SCV Cell Substrate for Manufacturing

Sementis Propriety SCV Platform Technology SCV Platform

•       SCV platform vaccine delivery vehicle – replication incompetent as proven by in vitro and in vivo infectivity studies (data published in Eldi etal (2017) Molecular Therapy, October edition)

•       Manufacturing friendly – CHO based cell substrate:

•       Suspension culturing in bioreactor – scalability

•       Culture in chemical defined medium

•       Production yields high

•       Applications in vaccination against infectious diseases as exampled by Sementis’ SCV-CHIK vaccine (data published in Eldi etal (2017) Molecular Therapy, October edition)

•       Applications in single vectored multidisease vaccines for infectious diseases as exampled by Sementis’ dual SCV-CHIK/ZIKA vaccine (data submitted for publication and in peer-review process)

•       Application in the treatment and cure for allergies (data to be ready for publication soon)

Molecular Therapy publication download from:

Principles of the SCV Approach

Live viral vector that offers:

•       the properties of attenuated vaccine

•       unable to multiply upon vaccination providing the added safety of inactivated vaccines

•       Accommodate multiple antigens to give the broad spectrum of subunit vaccines

A manufacturing process scalability by using a proprietary genetically engineered suspension cell substrate to produce all SCV vaccines

The SCV cell substrate for manufacturing is CHO based – industry gold standard for production of biologicals with the following advantages:

•       Biotechnology friendly: bioreactor and processes are standardize to CHO cells

•       Fastest growing cell substrate, important for upscaling

•       Suspension culture requiring low surface area to volume culturing systems

•       Most characterised cell line used for the production medicinal biologicals

•       Well know and understood by medical control agency around the word (TGA in Australia, FDA in USA, EMEA in Europe)

How does SCV Work: Originated from Smallpox Vaccine

Cell Substrate for Manufacturing

Development of a cell substrate for the rescue of progeny virus required to manufacture SCV

CHO cells were chosen for the basis of constructing a transgenic SCV-rescue cell line for the following reasons:

Yields & Scale up ability

• Fast rate of growth
• High cell density culturing
• Suspension culture in BioReactors
• Chemically defined protein-free growth media available

Characterisation

• Most characterized cell line
• Genome recently sequenced by the CHO Consortium
• Refractory to infection by human viruses
• Endogenous retroviral like particles are proven to be non-infectious

Regulatory experiences

• Well known to medical control agencies such as FDA and EMEA
• 20 years of proven history as a cell substrate for the production of licensed biological products, eg, monoclonal antibodies, hormones and enzymes
• Guidelines available for the development of transgenic-CHO cell lines as a cell substrate for biopharmaceutical products

Scaling up to 500L Bioreactor

Sementis’ SCV-cell substrate for manufacturing was derived from GMP produced CHO-S cell line:

•       Suspension cell line – suitable bioreactor production

•       Cultured in serum-free chemically defined medium

Vaccine Industry Practices

Witty CEO GSK: Big Pharma can help the poor and still make money

For GSK, it means making at least some profit in every single market, no matter how small that profit may be. Some investors might balk at that strategy and demand a greater return. But there’s also a compelling logic to the idea.

“We literally rank the world by [gross national income] per capita” when it comes to certain drugs such as vaccines, said Witty. Glaxo then applies a tiered pricing strategy based on economic need. And on the flip side, organizations like Gavi, the massive global public-private vaccine partnership, ensure a certain amount of purchases (albeit for a significantly reduced price) as long as companies commit to providing a reliable stream of treatments.

It’s a low-margin, high-volume proposition. But it’s one that Witty deeply believes is integral to serving the world’s “other six billion” who don’t live in middle-to-high income nations while hewing to the profit motive. He points to successes such as the part GlaxoSmithKline has played in reducing childhood mortality in sub-Saharan Africa by investing in an expensive vaccine manufacturing plant in Singapore.