cgmp Production on RFH Campus
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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!!!
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