Temperature Intelligence Solutions. Thermostability of Vaccines
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1 Thermostability of Vaccines
2 Why are all vaccines sensitive to heat and some to freezing? Why is thermostability of vaccine important? What can be done to improve the thermostability of vaccines?
3 Goals of stability studies in product development Establish product stability characteristics: Understand factors that influence stability strategies to minimize product decay during storage Generate real time and real condition stability data support proposed shelf life for licensure Establish forced degradation characteristics support post-licensure manufacturing changes Generate data at temperatures relevant to CTC From: WHO Informal Consultation on Scientific and Regulatory Considerations on Stability of Vaccines under a Controlled Temperature Chain Dean Smith &Tong Wu, Ph.D., Health Canada 4 June 2013, PEI, Langen, Germany
4 General considerations for stability studies Adequate testing points rates of product decay may differ at different intervals over the shelf-life Potency assessment using a battery of tests note that all tests have limitations Data analysis: Note trends, not just compliance with specifications Determine the rate of product decay using appropriate statistical methods: explore alternate approaches From: WHO Informal Consultation on Scientific and Regulatory Considerations on Stability of Vaccines under a Controlled Temperature Chain Dean Smith &Tong Wu, Ph.D., Health Canada 4 June 2013, PEI, Langen, Germany
5 Stability-indicating parameters Potency: most critical for vaccines Safety Residual toxin / reversibility of toxoid Toxicity of degradation products Additional parameters Moisture content for lyophilized vaccines: ph Adsorption to alum or other adjuvant characteristics From: WHO Informal Consultation on Scientific and Regulatory Considerations on Stability of Vaccines under a Controlled Temperature Chain Dean Smith &Tong Wu, Ph.D., Health Canada 4 June 2013, PEI, Langen, Germany
6 Vaccine Antigens: Complex Macromolecular Structures Review: Kumru O et al, Biologicals 42: 237 (2014) Live, Attenuated Virus: Measles, Mumps, Rubella, Varicella, Yellow Fever, Vaccinia, Rotavirus, Polio, Adenovirus Inactivated Virus: Recombinant Virus-like Particles: Live, Attenuated Bacteria: Inactivated Bacteria: Bacterial (proteins): Bacterial (polysaccharides): Hepatitis A, Polio, Influenza Human Papillomavirus, Hepatitis B BCG (tuberculosis), Typhoid Fever Anthrax, wpertussis apertussis, Diphtheria, Tetanus Haemophilus B, Pneumonia, Meningitis (often linked to protein carriers)
7 Examples of Commercial Vaccine Dosage Forms Review: Kumru O et al, Biologicals 42: 237 (2014) Recombinant or Inactived Viral Vaccines Adjuvant Formulation Delivery HPV, Hepatitis B Aluminum Liquid Injection Hepatitis A, Polio, Influenza (some with new adjuvants) Inactived, Purified or Conjugated Bacterial Vaccines wpertussis, Anthrax apertussis, Diphtheria, Tetanus, Anthrax Aluminum Liquid Injection Haemophilus B, Pneumonia, Meningitis (many linked to protein carriers) Live, Attenuated Viral Vaccines Measles, Mumps, Rubella, Varicella, None Lyophilized Injection Yellow Fever, Vaccinia Rotavirus, Polio, Liquid Oral Influenza Liquid Nasal Adenovirus Lyo/Tablet Oral Live, Attenuated Bacterial Vaccines BCG (tuberculosis), Typhoid Fever None Lyophilized Injection, Oral Slide Courtesy of Prof. David Volkin, Univ of Kansas
8 Vaccine Distribution World-Wide: Stability Issues in the Vaccine Cold Chain Review: Kumru O et al, Biologicals 42: 237 (2014) Freeze Sensitive? Heat Sensitive? Live Viral Vaccines - / Live Bacterial Vaccines - / Recombinant or Inactive Viral Vaccines / + Inactived, Purified or Conjugate Bacterial Vaccines / + Slide Courtesy of Prof. David Volkin, Univ of Kansas
9 Temperature sensitivity of vaccines B. Schreiber & D. Chang Blanc - TechNet Bangkok 2015
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11 Controlled Temperature Chain: No Ice packs for days Challenge for vaccine stability, safety and efficacy
12 Overview of Novel Approaches to Stabilize Vaccines Formulation Composition New additives New approaches to identify combinations of additives Formulation Processing Technologies Novel drying or delivery technologies Novel Antigens with Improved Stability Molecular design of current antigens New macromolecules: e.g., DNA/RNA vaccines Slide Courtesy of Prof. David Volkin, Univ of Kansas
13 Analysis of Some Interesting Approaches Formulation Composition Past Examples Formulation and Rationale Trehalose in the 1980s Deuterium Oxide in the 1990s Polyethylene glycol in the 2000s Lyophilized for heat stability Liquid for heat stability Liquid for freeze stability of alum vaccines Examples from Today Silk protein Vaxess Buffer mixtures Arecor Sucrose and raffinose Stabilitech Lipid mixtures VBI Vaccines Overall, novel additives have had a limited impact to date Slide Courtesy of Prof. David Volkin, Univ of Kansas
14 Novel approaches to identify stabilizers Increasing number of research papers on the use of high throughput screening technologies: Empirically identify unique combinations of common excipients Empirically focus on specific vaccine and specific stress Most likely will become useful tool in future, but more from point of view of resources, time, and potentially patents Slide Courtesy of Prof. David Volkin, Univ of Kansas
15 Novel drying and delivery technologies General Examples Formulation and Rationale Freeze-drying Lyophilized formulations of aluminum vaccines Spray-drying Lyophilized for heat stability Foam-drying Lyophilized for heat stability Microneedles Novel delivery technology Specific Examples: PATH Sologenix Aridis Aktiv-dry Nova Labs Slide Courtesy of Prof. David Volkin, Univ of Kansas
16 Novel Antigens with Improved Stability Molecular design to improve stability of antigens Many research papers and programs to improve antigen stability at molecular level Long term research programs New classes of macromolecular antigens with potential of improved stability e.g., commercial polysaccharide and protein VLP vaccines are more stable than viral vaccines e.g., peptide and nucleic vaccine candidates. RNA as vaccine candidates include: Curevac Moderna Novartis Vaccines (now GSK ) Slide Courtesy of Prof. David Volkin, Univ of Kansas
17 Highly Stable Rotavirus Vaccine 540 days at 37 C
18 Requirements to Implement From a Published Review from PATH Chen D, Kristensen D, Expert Rev Vaccines May;8(5): Opportunities and challenges of developing thermostable vaccines
19 Links to Pertinent Publications 19
20 Thank you!!!
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