GMP Live Biotherapeutic Products

Waisman Biomanufacturing (WB) has unique expertise in developing live biotherapeutic products up to Biological Safety Level 2 for vaccine or therapeutic use. WB can transfer or develop an aerobic fermentation process for high-density production in equipment scalable to late-stage clinical or commercial manufacturing.

WB also has expertise developing closed downstream processes that can be validated with aseptic process simulation (media fill) studies to ensure microbial live biotherapeutic products (LBP) are not contaminated. All LBP Drug Substances are manufactured in dedicated Microbial Processing Suites and can be filled as Drug Product for clinical use via WB's Aseptic Fill/Finish services. WB also offers full Quality Control support for live biotherapeutic products. 

Live Biotherapeutic Product Processes

• Fermentation in a 30L (w/v) high-density fermenter
• Harvest, concentration, and washing with close system transfer to single-use Tangential Flow Filtration systems
• Aseptic fill by automated, robotic fill and capping into a variety of glass vial sizes

Aseptic Processing

• Final, client-specific manufacturing workflows can be validated for aseptic processing by media fill simulations
• USP <62> testing to ensure there is no contamination by specified microorganisms

Full Quality Control Support

• Cell counts and optical density of solutions
• Cell viability
• Microbial purity
• Antibiotic sensitivity/resistance tests consistent with CLSI standards
• Custom assays such as PCR for verifying genetic modifications (e.g. attenuation)
• A variety of technologies to support potency (e.g. ELISA/Western blot)