Bacthera tailor live biotherapeutic product services to meet your needs, whether you are an early start-up, a fully established biotech company, or part of a pharma company working with live biotherapeutic products.
We offer a compelling set of services across the live biotherapeutic product value chain, from technical development right through to cGMP manufacture and release of drug substance and drug product.
Bacthera can help you with:
- A wide variety of strains, including fastidious and oxygen sensitive anaerobes, risk group 1 and 2 strains, and GMO1 strains.
- Cell banking and strain safety assessment.
- Integrated process development and upscaling to manufacture cell banks, drug substance, and drug product.
- Manufacturing of cell banks, drug substance, and drug product for use in pre-clinical studies clinical trials, and future commercial supply.
- Analytical development, including design and execution of stability programs, as well as characterization and release of live biotherapeutic products.
- Clinical trial set-up, production capacity models, IND and regulatory fillings.
- Design of drug development programs for live biotherapeutic products, including timelines, budgets and route to market / manufacturing ramp-up.