cgmp Production on RFH Campus

Size: px
Start display at page:

Download "cgmp Production on RFH Campus"

Transcription

1 cgmp Production on RFH Campus Dr Mark W Lowdell Director of Cellular Therapy Royal Free Hospital UCL Medical School London, UK Paul O Gorman Laboratory of Cellular Therapeutics Royal Free Hospital

2 How are cell therapy trials regulated? Pre Council of Europe begins proposals for regulation of clinical cell & tissue therapies 1997 UK DoH publishes CoP and voluntary accreditation scheme via MCA (MHRA) 1999 POG LCT accredits to voluntary scheme cgmp not required; proposal for EU GTP standards akin to FDA 2004 Clinical trials directives enacted include substantially modified somatic cells as IMP for the first time. cgmp manufacture required plus MA (IMP) and Qualified Person First LCT product to be deemed an IMP by MHRA 2009 ATMP Regulations published Procurement of starting material regulated by HTA and requiring licence nonsubstantial defined Inclusion of HEC for one-off, non-trial products

3 How are cell therapy medicinal products regulated? Investigational: MA(IMP) and QP required Clinical trials directives for conduct (GCP) Annex 1-13 of medicinal products directives ATMP regulations 2009 for manufacture (cgmp) HTA Quality & Safety Regulations Non-investigational: MA(Specials) (or HES) and QC required Annex 1-13 of medicinal products directives ATMP regulations 2009 for manufacture (cgmp) HTA Quality & Safety Regulations Both require full cgmp production

4 cgmp requirements cgmp production Document control Staff training Materials qualification, control & tracking Equipment qualification and validation Environmental control & monitoring Air borne particles (in process and at rest) Viable particles (settle plates, finger dabs and product testing) Open A in a B background (A in C in US) In isolators in D background Closed D environment Released products control & tracking AR/SAR reporting Paperwork more important than facility

5 How did we meet cgmp at RFH? New labs designed in 1999 to GTP standards in US Grade C background No Grade B gowning required so single stage change Opened in apparent that cgmp standards will be applied in UK Grade B background needed Increased air volume exchange no recirc possible Increased differential pressures increased fan speeds Grade B gowning Stage 1 change area needed BUT: cgmp gowning not compatible with human tissues (HOWIE rules) Wash hand basin required in de-gowning area Facility design imperfect for minimisation of X-contamination Process design to overcome limitations of facility design

6 EU vs FDA for open processes Grade Maximum permitted number of particles / m2 at or above size specified At Rest In Operation 0.5µm 5 m 0.5µm 5 m A ISO5 3, ,500 0 B ISO5 3, ,000 2,000 C ISO7 350,000 2,000 3,500,000 20,000 D ISO8 3,500,000 20,000 Not Defined Not Defined EU cgmp requires ISO5 in ISO5 background (at rest) but ISO7 background in operation FDA cgmp requires ISO5 in ISO7 background at rest and in operation (effectively a C )

7 How did we meet cgmp at RFH? Lab 2 - Class B Class C lab 28.26m 3 Locker Room & Stage 1 Change Store Room Quarantine 15.9m 3 Stage 2 Change 8..8m 3 Class C Stem cell and pre-imp processing Laboratory Lab 1 - Class B 40.8m 3 Lab 3 - Class B CO 2 incubator Fridge / freezer Bench (under bench) Class II microbiological cabinet Class A Lab 4 - Class B 18.0m 3 Critical work area Transfer hatch Wash hand basin

8 The RFH cgmp facility Lab 4 Lab 2 Lab 3

9 How did we meet cgmp at RFH? Dual standard operation Non-cGMP production Labs operated to Class B air standard BUT Gowning to Class C standard cgmp production All labs operate to cgmp with full class B gowning Campaign use of Labs Lab 1 is preparation lab for starting material (the only lab to be used for non-cgmp work) Lab 2 is preferred lab for short process cgmp manufacture Lab 3 is preferred lab for mid length cgmp manufacture (2 days) Lab 4 is the only lab for long-term cgmp manufacture (lines) and for islet cell production (most open procedure currently) No access to Lab 4 when Lab 3 is in operation and vice versa

10 Gowning and access Non-cGMP production A in a D background Sterile docker used to make most processed closed Although some are open

11 Gowning and access cgmp production - A in a B background

12 Our first cell therapy IMP - TaNK Pre-clinical testing Regular research data repeated to GLP standards

13 STABILITY OF CTV-1 PHENOTYPE THROUGH 28 MEDIA CHANGES MNC CD56 CD56 Donor x10^9 x10^9 x10^7/kg CD2 CD3 ccd3 CD4 CD5 CD7 CD8 CD15 CD19 CD33 CD34 CD56 HLA-DR % POSITIVE Week Comparison of CTV-1 proliferation in TC flasks (RPMI+10%FCS ) with cells cultured in T-cell expansion bag in X-VIVO 10 Cell count/ml 5.0 P1 P2 P3 P4 P5 P RPMI +10%fcs XVIVO-10 Frozen vials of CTV-1 from same previous passage were thawed and cultured in either RPMI+10%FCS or X-VIVO 10. Initial cell conc. for both 0.5x106/ml. Cells were split 50:50 every 48hours (except P5 were cells fed after 72hrs)with fresh medium and cell conc. checked

14 Our first cell therapy IMP - TaNK Pre-clinical testing Regular in vitro research data repeated to GLP standards No animal model (xenogeneic system inappropriate for safety or efficacy e.g Tegenero)

15 Our first cell therapy IMP - TaNK Pre-clinical scale-up Anti-CD56 selection reagent Immunomagnetic sorting system

16 Our first cell therapy IMP - TaNK Pre-clinical scale-up problems Validation Product definition? (e.g. MSC) Gold Standard reference analyte? Validated GLP assays? GLP labs? PSF design Starting materials are human cells and thus highly variable Functional assays impossible to validate to usual pharmaceutical standards

17 Our first cell therapy IMP - TaNK Manufacturing for phase I/II trial Release criteria Lack of reference analyte Highly variable functional assays In vitro potency assays not available on thawed product Viability not available on thawed product Sterility not available on fresh product

18 Our first cell therapy IMP - TaNK Current status Trial commenced 10 months late 14 patients enrolled and 8 treated in 18 months (1 off trial) No deaths in treated group 7/8 patients responded to treatment Trial closed

19 Planned cgmp facility for RFH Female stage 1 Grade C T&CD processing +4C +4C Grade D T&CD processing & QC Grade B Lab 2 Male stage 1 Grade B Lab 1 Grade B corridor Air Lock Gene Rx culture lab +4C Grade B Lab 4 Grade B -ve Gene Rx preparation lab Grade C Lab +4C Grade B Lab 3 LN2 Grade B -ve +4C +4C Quarantine Goods Store Stage 2 change +4C +4C +4C

20 Conclusions Increasingly we will have to move to full cgmp compliance This is less about facilities than systems Process can be used to overcome inadequacies of design Pragmatism is the order of the day don t gold plate the regulations BUT

21 Sometime even the best process can t overcome the design!!!

Controlling cell-based bioassay performance through controlled preparation of bioassayready

Controlling cell-based bioassay performance through controlled preparation of bioassayready Controlling cell-based bioassay performance through controlled preparation of bioassayready cells Teresa Surowy September 2013 Promega Corporation Introduction The importance of cell-based bioassays and

More information

STERILITY TESTING OF PHARMACEUTICAL PRODUCTS

STERILITY TESTING OF PHARMACEUTICAL PRODUCTS STERILITY TESTING OF PHARMACEUTICAL PRODUCTS Tim Sandle CONTENTS Introduction xiii 1 STERILITY 1 Introduction 1 Sterility 3 Microorganisms and Microbial Growth 5 Types of microorganisms 7 Sterilization

More information

What the Transfusion Scientist should know about Stem Cells. Dr Claire Wiggins BBTS September 2017

What the Transfusion Scientist should know about Stem Cells. Dr Claire Wiggins BBTS September 2017 What the Transfusion Scientist should know about Stem Cells Dr Claire Wiggins BBTS September 2017 What is a stem cell? Undifferentiated cell Can divide and self renew for long periods Differentiate into

More information

EU Regulatory Update & GMP Deficiencies. Bryan J Wright July 2017

EU Regulatory Update & GMP Deficiencies. Bryan J Wright July 2017 EU Regulatory Update & GMP Deficiencies Bryan J Wright July 2017 Slide 1 PharmOut 2017 Outline Update on changes in EU GMP Guide Summary of GMP changes to the Guide Important details of changes over the

More information

your bioassay is in good hands: transfer from a CRO perspective MIKE MERGES March 4, 2013

your bioassay is in good hands: transfer from a CRO perspective MIKE MERGES March 4, 2013 your bioassay is in good hands: transfer from a CRO perspective MIKE MERGES March 4, 2013 Contact Information Michael Merges, M.S. Director Analytical Development Solutions Development & Clinical Services

More information

Graft processing across Africa: What is available? Jackie Thomson Alberts cellular therapy Pretoria

Graft processing across Africa: What is available? Jackie Thomson Alberts cellular therapy Pretoria Graft processing across Africa: What is available? Jackie Thomson Alberts cellular therapy Pretoria Purpose of the talk range of activities, staffing, any problems you face both scientifically, logistically

More information

Food safety checklist for business operators

Food safety checklist for business operators Food safety checklist for business operators GOLD COAST How well does your food business rate? Under the City of Gold Coast s (City) Eat Safe Gold Coast food safety rating scheme, all licensed food businesses

More information

Thawing MEFs (Mouse Embryonic Fibroblasts (MEFs)

Thawing MEFs (Mouse Embryonic Fibroblasts (MEFs) 1 FEEDER CULTURES The function of feeder cultures is to support the undifferentiated growth of hpsc. Typically primary fibroblasts are used for this purpose. We prepare our mouse feeder cells from ICR

More information

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT MEMBER STATES EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 5 November 2008 ENTR/F/2/SF D(2008) 34957 GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON

More information

Environmental Monitoring in the Cell Processing Laboratory What to do with the data?

Environmental Monitoring in the Cell Processing Laboratory What to do with the data? Environmental Monitoring in the Cell Processing Laboratory What to do with the data? Shelly Heimfeld, Ph.D. Fred Hutchinson Cancer Research Center Seattle Cancer Care Alliance ISCT President Somatic Cell

More information

Executive Summary for Executive Licensing Panel 20 May Dr Kamal Ahuja. Follow-up inspection 14 April 2010

Executive Summary for Executive Licensing Panel 20 May Dr Kamal Ahuja. Follow-up inspection 14 April 2010 Summary for Licensing Panel 20 May 2010 Centre number 0011 Centre name The London Sperm Bank Person Responsible Dr Kamal Ahuja Background Follow-up inspection 14 April 2010 1. The London Sperm Bank underwent

More information

ISCT Workshop #7 Perspectives in Cell Selection Immunomagnetic Selection

ISCT Workshop #7 Perspectives in Cell Selection Immunomagnetic Selection ISCT Workshop #7 Perspectives in Cell Selection Immunomagnetic Selection Carolyn A. Keever-Taylor, PhD Medical College of Wisconsin June 7, 2012 History of Available Devices CellPro CEPRATE Avidin/Biotin

More information

Webinar. Risk Assessment Reusable Polyester and Single Use Tyvek IsoClean Cleanroom Garments Dupont

Webinar. Risk Assessment Reusable Polyester and Single Use Tyvek IsoClean Cleanroom Garments Dupont Webinar Risk Assessment Reusable Polyester and Single Use Tyvek IsoClean Cleanroom Garments Dupont 15 June 2018 GOP-Innovations your Partner for Practical Training and e-learning Milenko Pavičić Pharmaceutical

More information

SOP History Number Date Reason for Change v1 10/10/2014 Original V2 10/10/2016 Update V3 10/10/2018 Update

SOP History Number Date Reason for Change v1 10/10/2014 Original V2 10/10/2016 Update V3 10/10/2018 Update Document Number: SASoM/METHOD/073.v3 Title: Version: Author: Lentivirus production from HEK293T cells v3 Paul Reynolds Effective from: 10/10/2018 Valid to: 09/10/2020 SOP History Number Date Reason for

More information

Human CD4+T Cell Care Manual

Human CD4+T Cell Care Manual Human CD4+T Cell Care Manual INSTRUCTION MANUAL ZBM0067.04 SHIPPING CONDITIONS Human CD4+T Cells, cryopreserved Cryopreserved human CD4+T cells are shipped on dry ice and should be stored in liquid nitrogen

More information

Il ruolo delle VEQ per la sicurezza trasfusionale

Il ruolo delle VEQ per la sicurezza trasfusionale Il ruolo delle VEQ per la sicurezza trasfusionale The role of EQA for transfusion safety Giulio Pisani CNCF Ist. Sup. Sanità Global Blood Product Safety, Roma 10 aprile 2019 Blood transfusion is an essential

More information

Some Critical Remarks from German Chemical Industry on Certification and Accreditation in NDT

Some Critical Remarks from German Chemical Industry on Certification and Accreditation in NDT Some Critical Remarks from German Chemical Industry on Certification and Accreditation in NDT Opening Lecture 5 th International Conference on Certification and Standardization in NDT Berlin, September

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 21 September 2006 EMEA/CHMP/BWP/298390/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON

More information

Use Tomorrow s Technology Today

Use Tomorrow s Technology Today Use Tomorrow s Technology Today Company Profile (MES) is a leading edge company specializing in rapid, automated semen analysis for both the human and the veterinary markets. The Company s comprehensive

More information

Summary of Significant Changes. Policy

Summary of Significant Changes. Policy This Policy replaces POL186/2 Copy Number Effective 01/04/14 Summary of Significant Changes Clarification of policy approval process Paragraph 2.2.1 Clarification of Kidney Fast Track Scheme offering criteria

More information

UNIVERSITY OF WASHINGTON MEDICAL CENTER Men s Health Center and Male Fertility Laboratory Sperm & Testis Cryopreservation Program Patient NAME and ID

UNIVERSITY OF WASHINGTON MEDICAL CENTER Men s Health Center and Male Fertility Laboratory Sperm & Testis Cryopreservation Program Patient NAME and ID UNIVERSITY OF WASHINGTON MEDICAL CENTER Men s Health Center and Male Fertility Laboratory Sperm & Testis Cryopreservation Program Patient NAME and ID CONSENT FOR MINOR s SPERM OR TESTIS CRYOPRESERVATION

More information

Overview Internal review

Overview Internal review Overview Internal review Presentation title: QRM, It s not all about the assessment Track title: Day 1, Session 2 Speaker: Seamus Orr Date / Time: 10 August 2015, 14.30 15.00 Time allotted: 30 minutes

More information

Environmental Monitoring How to Satisfy the Regulator. Presented by Tanja Varglien, July 2017

Environmental Monitoring How to Satisfy the Regulator. Presented by Tanja Varglien, July 2017 Environmental Monitoring How to Satisfy the Regulator Presented by Tanja Varglien, July 2017 Slide 1 PharmOut 2017 Using Glisser You will be able to tap the download link at the end of each presentation.

More information

Proper steps for bull semen dilution and freezing. IMV Technologies France

Proper steps for bull semen dilution and freezing. IMV Technologies France Proper steps for bull semen dilution and freezing IMV Technologies France Introduction Since Polge reported the first successful cryopreservation of spermatozoa in 1949, spermatozoa from many mammalian

More information

Clinical Translation of Immunotherapy using WT1 and CMV specific TCR Gene Transfer

Clinical Translation of Immunotherapy using WT1 and CMV specific TCR Gene Transfer Clinical Translation of Immunotherapy using WT1 and CMV specific Gene Transfer Dr Emma C Morris Reader, Dept of Immunology, UCL Consultant Haematologist (BMT), UCLH and RFH ISCT, 2/5/211 Gene Transfer

More information

Human Umbilical Cord Blood CD34 + /133+ Progenitor Cell Care Manual

Human Umbilical Cord Blood CD34 + /133+ Progenitor Cell Care Manual Human Umbilical Cord Blood CD34 + /133+ Progenitor Cell Care Manual INSTRUCTION MANUAL ZBM0065.04 SHIPPING CONDITIONS Human Umbilical Cord Blood CD34+/133+ Progenitor Cells, cryopreserved Cryopreserved

More information

Human Umbilical Vein Endothelial Cell Manual

Human Umbilical Vein Endothelial Cell Manual Human Umbilical Vein Endothelial Cell Manual INSTRUCTION MANUAL ZBM0079.03 SHIPPING CONDITIONS Human Umbilical Vein Endothelial Cells, cryopreserved Cryopreserved cells are shipped on dry ice and should

More information

To place an order, please visit lifelinecelltech.com or call customer service at

To place an order, please visit lifelinecelltech.com or call customer service at Human Melanocyte Cells Instruction Manual HEMn Human Epidermal Melanocytes, Neonatal HEMn-HP Human Epidermal Melanocytes, Neonatal-Highly Pigmented HEMa Human Epidermal Melanocytes, Adult HEMa-HP Human

More information

Human Induced Plutipotent Stem Cell (ipsc) Handling Protocols: Matrigel and mtesr/e8 Media

Human Induced Plutipotent Stem Cell (ipsc) Handling Protocols: Matrigel and mtesr/e8 Media General Guidelines for Handling Human ipsc cells ipsc are cryopreserved in plastic cryovials and shipped on dry ice. If storing the ipsc before thawing, store in liquid nitrogen vapor. Storage directly

More information

Accreditation of BMT units & EU Regulations

Accreditation of BMT units & EU Regulations Accreditation of BMT units & EU Regulations April 1, 2008 EBMT Annual Meeting Workshop: EU regulation/standardisation of cellular therapy Presentation: JACIE: aims and current activities EU regulation

More information

MHRA Manufacturing Authorisation for - Investigational Medicinal Products (MA-IMP) - Specials

MHRA Manufacturing Authorisation for - Investigational Medicinal Products (MA-IMP) - Specials RCTS MHRA Manufacturing Authorisation for - Investigational Medicinal Products (MA-IMP) - Specials Cells for cellular therapies Viral vectors for gene therapy Stem cells for regenerative medicine Production

More information

Quality and Safety of HSCT in Autoimmune Diseases

Quality and Safety of HSCT in Autoimmune Diseases Quality and Safety of HSCT in Autoimmune Diseases Dr John Snowden Stem Cell Transplant Programme Director Sheffield Teaching Hospitals and University of Sheffield & JACIE Medical Director 1 HSCT is GROWING

More information

cryotubes Information from Biochrom AG, May 23, 2011

cryotubes Information from Biochrom AG, May 23, 2011 Recommendations on how to safely freeze and thaw cell cultures in TPP cryotubes Information from Biochrom AG, May 23, 2011 Cryopreservation can be used to store cell cultures for a virtually indefinite

More information

Human Mammary Luminal Epithelial Cells. Manual

Human Mammary Luminal Epithelial Cells. Manual Human Mammary Luminal Epithelial Cell Manual INSTRUCTION MANUAL SHIPPING CONDITIONS ZBM0071.00 Human Mammary Luminal Epithelial Cells Orders are delivered via Federal Express courier. All US and Canada

More information

Biopharmaceutics Classification System: Defining a Permeability Class

Biopharmaceutics Classification System: Defining a Permeability Class Biopharmaceutics Classification System: Defining a Permeability Class Blair Miezeiewski, M.S. Senior Scientist, In Vitro Permeability Lab Definition of Bioequivalence The United States Food and Drug Administration

More information

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer

Medidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer Nano-Tera.ch 05 February 2015 part 4 Intro ISO GMP - GLP Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 Introduction to ISO 13485, cgmp s and GLP s Context

More information

Jovona Powelson, B.S. MLT (ASCP) Director of Laboratories

Jovona Powelson, B.S. MLT (ASCP) Director of Laboratories Jovona Powelson, B.S. MLT (ASCP) Director of Laboratories Blood Products From the Donor to You Objectives Deliver a brief virtual tour of a blood center. Describe the number of donors needed to meet the

More information

Regulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help.

Regulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. Regulatory Support for Tobacco Products Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. PREMARKET TOBACCO (PMTA) HUMAN FACTORS STUDIES SUBSTANTIAL EQUIVALENCE

More information

Human ipsc-derived Ventricular Cardiomyocytes. Protocol version 3.1

Human ipsc-derived Ventricular Cardiomyocytes. Protocol version 3.1 Human ipsc-derived Ventricular Cardiomyocytes Protocol version 3.1 Protocol version 3.1 Table of Contents Product Information 2 Recommendations 2 Preparing Cardiomyocyte Maintenance Medium 3 Cardiomyocyte

More information

AmoyDx TM BRAF V600E Mutation Detection Kit

AmoyDx TM BRAF V600E Mutation Detection Kit AmoyDx TM BRAF V600E Mutation Detection Kit Detection of V600E mutation in the BRAF oncogene Instructions For Use Instructions Version: B3.1 Date of Revision: April 2012 Store at -20±2 o C 1/5 Background

More information

Comparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome

Comparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome Comparability and quality of experimental data under different quality systems S. Caroli Istituto Superiore di Sanità Rome Programme of this presentation Part I. Background information Part II. Key aspects

More information

Critical process for vaccine manufacturing and process validation

Critical process for vaccine manufacturing and process validation Critical process for vaccine manufacturing and process validation Inactivation Influenza Vaccine Production Project The Government Pharmaceutical Organization Presented by Ms RATSAMIKORN SINGCHAREON and

More information

AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY BACHELOR OF DENTAL PROSTHETICS PROGRAM. August 2017

AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY BACHELOR OF DENTAL PROSTHETICS PROGRAM. August 2017 AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY BACHELOR OF DENTAL PROSTHETICS PROGRAM August 2017 1. EXECUTIVE SUMMARY Program provider Program/qualification name Program/qualification

More information

Town and Country Compounding and Consultation Services, LLC 10/17/17

Town and Country Compounding and Consultation Services, LLC 10/17/17 Town and Country Compounding and Consultation Services, LLC 10/17/17 Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973)

More information

15. Procuring, processing and transporting gametes and

15. Procuring, processing and transporting gametes and 15. Procuring, processing and transporting gametes and embryos Version 6.0 On this page: : Extracts from the HFE Act Directions HFEA guidance: Documented procedures: general Patient selection and procurement

More information

Autologous plasma eye drops. Patient information

Autologous plasma eye drops. Patient information Autologous plasma eye drops Patient information Autologous plasma eye drops are made from the patient s own blood and are used to help treat their corneal surface defects and diseases. This leaflet gives

More information

Validation Introduction. Presented by John Montalto 27 March, 2013

Validation Introduction. Presented by John Montalto 27 March, 2013 Validation Introduction Presented by John Montalto 27 March, 2013 John Montalto Bachelor of Science Management Diploma >15 years of Industry Experience Consultant to United Nations various Government Regulatory

More information

Guide to the preparation, use and quality assurance of blood components

Guide to the preparation, use and quality assurance of blood components Contents Foreword...3 Members of the European Committee (Partial Agreement) on Blood Transfusion... 8 Members of the GTS working group... 22 Members of the TS066 working group... 30 Recommendation No.

More information

Temperature Excursion and Digital Data Loggers. Vaccine Cold Chain. Maintaining the Cold Chain 6/7/2018

Temperature Excursion and Digital Data Loggers. Vaccine Cold Chain. Maintaining the Cold Chain 6/7/2018 Temperature Excursion and Digital Data Loggers Jayme Lewis, RN & Allison Alejos, RN, BSN & Bradley Carpenter environment of all Kansans. Vaccine Cold Chain Elements for an Effective and Reliable Cold Chain:

More information

Biological Consulting Services of North Florida, Inc.

Biological Consulting Services of North Florida, Inc. Biological Consulting Services of North Florida, Inc. March 20, 2017 Project Manager 6915 Meade St. Pittsburg, PA 15208 757-817-3897 uriel@rorusinc.com Client ID: Core Filter 1, Core Filter 2, Core Filter

More information

ACTG Laboratory Technologist Committee Revised Version 2.0 ACTG Lab Man HIV Syncytium-Inducing (MT-2) assay 29 April 2004

ACTG Laboratory Technologist Committee Revised Version 2.0 ACTG Lab Man HIV Syncytium-Inducing (MT-2) assay 29 April 2004 HIV SYNCYTIUM-INDUCING (MT-2) ASSAY 1. BACKGROUND and CLINICAL SIGNIFICANCE Host and viral factors may play a role in determining the way in which an individual responds to anti-retroviral therapy. Presence

More information

Pluricyte Cardiomyocytes

Pluricyte Cardiomyocytes Pluricyte Cardiomyocytes Manual Version 2.1 / March 2018 Contents 1. Introduction 2 2. Equipment, Materials and Reagents 3 3. Methods 4 3.1 Coating of tissue culture plates 4 3.2 Thawing Pluricyte Cardiomyocytes

More information

Guidance for Pharmacists on Extemporaneous Dispensing

Guidance for Pharmacists on Extemporaneous Dispensing Guidance for Pharmacists on Extemporaneous Dispensing Pharmaceutical Society of Ireland Version 1 June 2015 Contents 1. Introduction 2 2. Legislative Basis and Implications 3 3. Guidance 4 3.1 Key Responsibilities

More information

The New Regulations - Special IVD Issues

The New Regulations - Special IVD Issues The New Regulations - Special IVD Issues Dirk Stynen, Ph. D. President - Principal Consultant Qarad Geel, Belgium RMD Brussels October 2018 The IVD Regulation 2017/746 October 29, 2018 www.qarad.com 2

More information

Sterility Assurance and Risk Management: A CDER Microbiologist s Perspective

Sterility Assurance and Risk Management: A CDER Microbiologist s Perspective Sterility Assurance and Risk Management: A CDER Microbiologist s Perspective John W. Metcalfe, Ph.D. Senior Review Microbiologist FDA/CDER/OPQ/OPF/Division of Microbiology Assessment Center for Drug Evaluation

More information

Latest range of highest quality sterile and filtered cleanroom alcohols

Latest range of highest quality sterile and filtered cleanroom alcohols Latest range of highest quality sterile and filtered cleanroom alcohols Shield Medicare Company Profile Shield Medicare is a market leader in the supply of specialist contamination control products to

More information

17. Storage of gametes and embryos

17. Storage of gametes and embryos 17. Storage of gametes and embryos This guidance note contains: Mandatory requirements Extracts from the HFE Act 1990 (as amended) Extracts from licence conditions Reference to relevant HFEA Directions

More information

Single Dose Vial / Repackaging FactFinder

Single Dose Vial / Repackaging FactFinder Single Dose Vial / Repackaging FactFinder Committed to providing helpful information to International Spine Intervention Society members about key patient safety issues, the Society s Patient Safety Committee

More information

Federal Agency for Medicines and Health Products

Federal Agency for Medicines and Health Products Federal Agency for Medicines and Health Products FAMHP Active partner in the EU regulatory framework Supporting innovative drug development Greet Musch BRUSSELS, 9 September 2017 1. Strategy of the FAMHP

More information

Curriculum Vitae. Lone Cleveland Andersen. Courses

Curriculum Vitae. Lone Cleveland Andersen. Courses Courses and continuing education, listed by subjects. GMP courses API Curriculum Vitae Lone Cleveland Andersen Courses ICH Q7; Compliance for API s manufactured by cell culturing and fermentation, European

More information

Reprocessing of Intra-Cavity Ultrasound Transducers

Reprocessing of Intra-Cavity Ultrasound Transducers GUIDELINE Reprocessing of Intra-Cavity Ultrasound Transducers This guideline describes the minimum recommended requirements for reprocessing Intra-cavity Ultrasound Transducers in Queensland Health facilities.

More information

2018 CDC VFC Compliance Visit Requirements & Recommendations

2018 CDC VFC Compliance Visit Requirements & Recommendations 2018 CDC VFC Compliance Visit Requirements & Recommendations ELIGIBILITY & DOCUMENTATION Changes to Key Staff All changes in key staff must be communicated to the Immunization Program in the manner and

More information

IVF Hammersmith Hospital (0078) Date of inspection 26 th July Date of Licence Committee 30 th November 2005

IVF Hammersmith Hospital (0078) Date of inspection 26 th July Date of Licence Committee 30 th November 2005 Human Fertilisation and Embryology Authority Report of an interim inspection at IVF Hammersmith Hospital (0078) Date of inspection 26 th July 2005 Date of Licence Committee 30 th November 2005 1 Contents

More information

Chris Bohl, Ph.D. Global Technical Support Manager- Products

Chris Bohl, Ph.D. Global Technical Support Manager- Products Chris Bohl, Ph.D. Global Technical Support Manager- Products cbohl1@xenotechllc.com Sekisui XenoTech Overview GLP-compliant in vitro ADME-DMPK CRO founded in 1994 at the University of Kansas Medical Center

More information

Capturing lightning In A Bottle

Capturing lightning In A Bottle Capturing lightning In A Bottle Featured In: Manufacturing & Capabilities I Facility of the Year I ISPE By Stephen Hall, Senior Director, Engineering, MannKind Corporation; Juergen Martens, Chief Technical

More information

Information about. Egg donation. Tel. (UK): +44(0) Tel. (Spain):

Information about. Egg donation.  Tel. (UK): +44(0) Tel. (Spain): Information about Egg donation www.ginefiv.co.uk Tel. (UK): +44(0)203 129 34 19 Tel. (Spain): +34 91 788 80 70 Index This brochure contains the following information: Index About Ginefiv...3 Our Egg Donation

More information

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 8.12.2008 COM(2008) 818 final 2008/0238 (COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety

More information

Human Gingival Epithelial Cells. Protocol version 1.0

Human Gingival Epithelial Cells. Protocol version 1.0 Human Gingival Epithelial Cells Protocol version 1.0 Protocol version 1.0 Table of Contents Human Gingival Epithelial Cells 2 Recommendations 2 Thawing and Plating 2 Passaging 3 Usage Statement 3 1 Human

More information

SCAN RDI PROTOCOLS FOR ENVIRONMENTAL MONITORING

SCAN RDI PROTOCOLS FOR ENVIRONMENTAL MONITORING SCAN RDI PROTOCOLS FOR ENVIRONMENTAL MONITORING Menu Surface monitoring using ChemSwab Air Monitoring using Coriolis µ Bioburden in raw materials and intermediates 2 Menu Surface monitoring using ChemSwab

More information

Human Keratinocytes. Protocol version 1.0

Human Keratinocytes. Protocol version 1.0 Human Keratinocytes Protocol version 1.0 Protocol version 1.0 Table of Contents Human Keratinocytes 2 Recommendations 2 Thawing and Plating 2 Passaging 3 Usage Statement 3 1 Human Keratinocytes Human

More information

Developing Bioanalytical Methods Balancing the Statistical Tightrope

Developing Bioanalytical Methods Balancing the Statistical Tightrope Developing Bioanalytical Methods Balancing the Statistical Tightrope Lee: can I use this number? Process Development GSK, 1997 2 it s about 40 about 40? probably... 3 Enlightenment? 5 Unconscious Conscious

More information

Directions given under the Human Fertilisation and Embryology Act 1990 as amended. Ref: 0006 Version: 4

Directions given under the Human Fertilisation and Embryology Act 1990 as amended. Ref: 0006 Version: 4 Directions given under the Human Fertilisation and Embryology Act 1990 as amended Import and export of gametes and embryo Ref: 0006 Version: 4 These Directions are: GENERAL DIRECTIONS Sections of the Act

More information

6/7/2017 CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE DISCLOSURE OBJECTIVES

6/7/2017 CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE DISCLOSURE OBJECTIVES CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE John Karwoski, RPh, MBA DISCLOSURE I, John Karwoski, RPH, MBA have business relationships with the companies MOBIUS THERAPEUTICS, LLC, Cubex, and

More information

Implication and Experience of AFSSAPS in the release of Poliomyelitis Vaccines

Implication and Experience of AFSSAPS in the release of Poliomyelitis Vaccines Implication and Experience of AFSSAPS in the release of Poliomyelitis Vaccines 7 th WHO/UNICEF Consultation with OPV/IPV Manufacturers and RNAs S. MORGEAUX- CVV Unit DLC Lyon site Inactivated Poliomyelitis

More information

Database on Blood Safety 2009 in ECO Member States

Database on Blood Safety 2009 in ECO Member States Database on Blood Safety 2009 in ECO Member States Section 1: Administrative Information Information provided by: 1.1 Name: 1.2 Title: 1.3 Position: 1.4 Organization: 1.5 Address: 1.6 Country: 1.7 Tel.

More information

Regulation of ART. S.T.A.R.T. Melbourne, 19 th February, 2017

Regulation of ART. S.T.A.R.T. Melbourne, 19 th February, 2017 S.T.A.R.T. Melbourne, 19 th February, 2017 Regulation of ART Phill Matson Fertility North, Joondalup, WA & Edith Cowan University, WA Chair, Reproductive Technology Accreditation Committee Regulation of

More information

Human Pluripotent Stem Cell Cardiomyocyte Differentiation Kit (PSCCDK) Introduction Kit Components Cat. # # of vials Reagent Quantity Storage

Human Pluripotent Stem Cell Cardiomyocyte Differentiation Kit (PSCCDK) Introduction Kit Components Cat. # # of vials Reagent Quantity Storage Human Pluripotent Stem Cell Cardiomyocyte Differentiation Kit (PSCCDK) Catalog #5901 Introduction Human pluripotent stem cells (hpsc), including embryonic stem cells (ESC) and induced pluripotent stem

More information

Quality Management Aspects of Sperm and Testicular Tissue Cryobanking

Quality Management Aspects of Sperm and Testicular Tissue Cryobanking ESHRE Campus, Granada (Spain), 25-26 March 2010 Quality Management Aspects of Sperm and Testicular Tissue Cryobanking Dr David Mortimer, PhD Oozoa Biomedical Inc Vancouver, BC, Canada Commercial Conflicts

More information

ab LDL Uptake Assay Kit (Fluorometric)

ab LDL Uptake Assay Kit (Fluorometric) ab204716 LDL Uptake Assay Kit (Fluorometric) Instructions for Use For rapid, sensitive and accurate measuring of LDL uptake. This product is for research use only and is not intended for diagnostic use.

More information

Cisbio Bioassays MAP-Tau assay is only intended for quantitative measurement of microtubule-associated protein tau (MAP-Tau) using HTRF technology.

Cisbio Bioassays MAP-Tau assay is only intended for quantitative measurement of microtubule-associated protein tau (MAP-Tau) using HTRF technology. MAP-TAU KITS PROTOCOL Part # 63ADK008PEG & 63ADK008PEH Test size#: 500 tests (63ADK008PEG), 10,000 tests (63ADK008PEH) - assay volume: 20 µl Revision: 02-Jan.2018 Store at: -20 C or below (63ADK008PEG);

More information

CryoStor CS2, CS5 and CS10 FREEZE MEDIA

CryoStor CS2, CS5 and CS10 FREEZE MEDIA CryoStor CS2, CS5 and CS10 FREEZE MEDIA Pre-Formulated Serum-Free Protein-Free cgmp Manufactured FDA Master File Sterility, Endotoxin, and Cell-Based Release Testing CryoStor, a series of cell-specific,

More information

PRIME-XV Dendritic Cell Maturation CDM

PRIME-XV Dendritic Cell Maturation CDM PRIME-XV Dendritic Cell Maturation CDM Chemically defined, animal component-free medium for dendritic cell culture Optimized for differentiation of monocytes into immature dendritic cells (idcs) and subsequent

More information

For research or further manufacturing use only. Not for injection or diagnostic procedures.

For research or further manufacturing use only. Not for injection or diagnostic procedures. PRIME-XV T cell Expansion XSFM PRIME-XV T Cell Expansion XSFM is a xeno-free, serum-free medium optimized for the activation and expansion of human T lymphocytes. This medium contains gentamicin and requires

More information

AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY DOCTOR OF CLINICAL DENTISTRY IN PERIODONTOLOGY. May 2015

AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY DOCTOR OF CLINICAL DENTISTRY IN PERIODONTOLOGY. May 2015 AUSTRALIAN DENTAL COUNCIL REPORT OF AN EVALUATION OF GRIFFITH UNIVERSITY DOCTOR OF CLINICAL DENTISTRY IN PERIODONTOLOGY May 2015 1. EXECUTIVE SUMMARY Program provider Program/qualification name Program/qualification

More information

The Texas Medical Center

The Texas Medical Center ISCT Regional Meeting November 2 4, 2007 Cryopreservation - Evaluation of Different Processes Presenters: Carlos Lee & Renee Smilee The Texas Medical Center Center for Cell & Gene Therapy The Feigin Center

More information

MHC MULTIMER PROFICIENCY PANEL 2017

MHC MULTIMER PROFICIENCY PANEL 2017 MHC MULTIMER PROFICIENCY PANEL 2017 August 2017 CONTACT Charlotte Halgreen ProficiencyPanel@immudex.com FOR MORE INFORMATION www.proficiencypanel.com MHC MULTIMER PROFICIENCY PANEL 2017 This report summarizes

More information

How Do You Know If a Sterilized Package Remains Sterile?

How Do You Know If a Sterilized Package Remains Sterile? How Do You Know If a Sterilized Package Remains Sterile? 1 Acknowledgments Bioaerosol and Applied Microbiology Team Brian Heimbuch, MS Group Lead Del Harnish, MS Lead Technical Mike McDonald, MS Lead Engineer

More information

WHAT DO MANUFACTURERS AND IMPORTERS HAVE TO DO TO PREPARE FOR EU MEMBERSHIP?

WHAT DO MANUFACTURERS AND IMPORTERS HAVE TO DO TO PREPARE FOR EU MEMBERSHIP? WHAT DO MANUFACTURERS AND IMPORTERS HAVE TO DO TO PREPARE FOR EU MEMBERSHIP? pharmaceutical regulatory affairs consulting and education www.rapharm.eu Vesna Koblar, MD. PhD. EU28: Science, Medicines, Health

More information

Certificate of Analysis JCCRM 811-1

Certificate of Analysis JCCRM 811-1 Reference Material Institute for Clinical Chemistry Standards (ReCCS) Certificate of Analysis Certified Reference Material for Measurement of Uric Acid in Human Serum JCCRM 811-1 Intended use This certified

More information

How Do You Know If Your Sterilized Instruments Remain Sterile?

How Do You Know If Your Sterilized Instruments Remain Sterile? How Do You Know If Your Sterilized Instruments Remain Sterile? Disclosure Harry Shaffer is the first author of the sterility maintenance study covered in this presentation and has been compensated by Halyard

More information

Blood Supply and Wastage

Blood Supply and Wastage Blood Supply and Wastage Inga Willett Lab Matters, Oake Manor, 21 st June 2017 Blood supply UK supplied by 4 blood services: SNBTS NIBTS NHSBT WBS http://commons.wikimedia.org/wiki/file:uk_map_home_nations.png

More information

THE UNIVERSITY OF NEWCASTLE- DISCIPLINE OF MEDICAL BIOCHEMISTRY. STANDARD OPERATING PROCEDURE PROCEDURE NO: GLP 072 MOD: 1st Issue Page: 1 of 6

THE UNIVERSITY OF NEWCASTLE- DISCIPLINE OF MEDICAL BIOCHEMISTRY. STANDARD OPERATING PROCEDURE PROCEDURE NO: GLP 072 MOD: 1st Issue Page: 1 of 6 Page: 1 of 6 Making Polyacrylamide gels - Ashman 1. Risk Assessment: This Risk Assessment is to be used as a general guide and as such, cannot accommodate all the varying factors that may be encountered

More information

CELL LINE INFORMATION FORM

CELL LINE INFORMATION FORM CELL LINE INFORMATION FORM To: Cell Biology & Imaging Division. National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar. Hertfordshire. EN6 3QG UK Please complete

More information

Biomanufacturing Training and Education Center (BTEC) s International Influenza Vaccine Manufacturing Training Program

Biomanufacturing Training and Education Center (BTEC) s International Influenza Vaccine Manufacturing Training Program Biomanufacturing Training and Education Center (BTEC) s International Influenza Vaccine Manufacturing Training Program 5 th Meeting with International Partners on Prospects for Influenza Vaccine Manufacturing

More information

ACTG Laboratory Technologist Committee Revised Version 1.0 ACTG Lab Man Qualitative CSF/PBMC Microculture Assay 22 April 2004

ACTG Laboratory Technologist Committee Revised Version 1.0 ACTG Lab Man Qualitative CSF/PBMC Microculture Assay 22 April 2004 1. PRINCIPLE QUALITATIVE CSF/PBMC MICROCULTURE ASSAY 1.1 Human immunodeficiency virus (HIV) has been shown to be the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS). Isolation of HIV-1 from

More information

3 Introduction. Figure 1.1. Figure 1.2. Board of Directors. Professional Advisory Board. Executive Committee. Finance

3 Introduction. Figure 1.1. Figure 1.2. Board of Directors. Professional Advisory Board. Executive Committee. Finance 1 Introduction It seems that we hear news reports of disasters in IVF clinics almost weekly. Public concern over these reports has resulted in governments introducing regulation of IVF labs around the

More information

Methodology for the Extraction of Plasmodium Protein. Learning Objectives:

Methodology for the Extraction of Plasmodium Protein. Learning Objectives: Proteomics Extraction of Plasmodium Protein Methodology for the Extraction of Plasmodium Protein Extraction of entire protein from the sample requires an optimized protocol and many protocols have been

More information

Parametric Release Regulatory Requirements. Terry E. Munson Technical Vice President PAREXEL International, LLC

Parametric Release Regulatory Requirements. Terry E. Munson Technical Vice President PAREXEL International, LLC Parametric Release Regulatory Requirements Terry E. Munson Technical Vice President History First application approved for parametric release in 1985 Formed the basis for the FDA Compliance Policy Guide

More information

Status Update on the Review of DMFs

Status Update on the Review of DMFs Status Update on the Review of DMFs Presented by Dave Skanchy, Ph.D. Director DMF Review Staff GPhA/FDA CMC Workshop June 4, 2013 1 Outline Changes to the DMF Review Staff: Update on GDUFA hiring and the

More information

Monday, 22 January 2018 HFEA, 10 Spring Gardens, London SW1A 2BU

Monday, 22 January 2018 HFEA, 10 Spring Gardens, London SW1A 2BU Monday, 22 January 2018 HFEA, 10 Spring Gardens, London SW1A 2BU Panel members Members of the Executive External adviser Caylin Joski-Jethi (Chair) Jessica Watkin Helen Crutcher Bernice Ash Nana Gyamfi

More information