Expediting Viral-Vector Based Vaccine Development for Covid-19: Solving the Supply Chain and Regulatory Challenges
As the impact of the Covid-19 pandemic continues to be seen across the world, government bodies, academic collaborations and pharma companies race to produce effective vaccine candidates. With more than 115 companies actively engaged in this endeavour, we see approximately 20% of these vaccine candidates focused on viral vector delivery systems, some already entering phase I clinical trials. Speed to clinic is of paramount importance, however, as producing a commercial vaccine can take many years; how then can we accelerate vaccine development with speed and safety in mind?
First entry into the heavily regulated world of GMP manufacturing and drug product release can challenging. Fortunately, working with experienced partners can guide and accelerate your progression from vector design to phase I manufacturing. In this presentation we will examine how integrated approaches to cell banking & testing; viral vector testing, cell culture media manufacturing and single use manufacturing solutions can be adopted into your production strategy to simplify progression and ensure rapid release of your drug product. Further we will present the regulatory testing requirements for each critical component and manufacturing process step and offer guidance on potential rapid release strategies.
Key Message of Webinar
- Sartorius viral vector expression platform integrated solutions will accelerate your vaccine development with speed and safety
- Sartorius cell culture media manufacturing services will increase safety of supply and continuity for vaccine manufacture and scale-up
- Sartorius ready to use buffer solutions will save time; money and provide quality assurance into your manufacturing process
- Cell bank manufacturing and testing of your MCB / WCB in a closed system with highly experienced production and quality professional ensures rapid movement from development to manufacturing
- Viral Vector regulatory biosafety testing is complex and time consuming, Sartorius can provide quality assured ready to use solutions to meet global regulatory standards and rapid testing solution strategies
Key Learning Objectives
- Sartorius integrated cell line testing & banking, viral vector testing, media manufacturing & single use manufacturing solution specific to viral vector manufacture
- Cell banking options and regulatory release requirements
- The complexity of ensuring viral safety from contaminating agents in a viral vector drug product and the methodologies to address this
- Viral Vector biosafety testing regulatory requirements for the Master Virus; Working Virus Seed Stocks, Bulk Harvest, Bulk drug Substance and Drug Product
- How to use rapid testing methods to accelerate the manufacturing process
Meet Our Experts
Product Manager: Viral Vector Applications
Lorraine Borland BSc, 30 years’ experience in biotechnology industry, specialising in cGMP contract manufacturing of viral vector products such as Adenovirus (serotypes 4, 5 & 7 / Non- Human Primate Adenovirus); HSV, retrovirus, Sendia, rMVA and VEEV, as well as plasmid DNA, mammalian cell based products, cell therapy and whole cell bacterial vaccines for phase I-III clinical trials.
Érica Schulze, PhD
Title Product Manager: Virus Applications
Érica Schulze PhD, was appointed several research associate positions throughout her academic career in Brazil, Canada and Germany, in which she worked with mammalian cell culture for the process development of vaccines, recombinant proteins and gene therapeutics. She worked as Media Application Specialist at Sartorius Stedim Biotech in Germany to support customers in cell culture media applications for the production of biopharmaceuticals in EMEA. In 2018 she was assigned the role of Product Manager for Cell Culture Media to support Vaccine Applications worldwide. She is responsible to set the feature definition for vaccine product lines and for guiding the success of these products.