GMP Extracellular Vesicle (EV)/Secretome Products

Waisman Biomanufacturing specializes in CGMP manufacturing of extracellular vesicles and secretome products from stem cells or other mammalian cells. Our top priority is to collaborate on process development and quality control methods to help advance your program into Phase 1 or Phase 2 clinical trials. With years of experience in suspension and adherent mammalian cell culture, downstream purification through TFF and chromatography, validated aseptic fill services, and product characterization defined by critical quality attributes, we are equipped to support your program's success.

EV/Secretome Processes

Our manufacturing scientists have broad experience to transfer your established process or collaborate on developing one custom. All unit operations are well-established by past experience in similar programs:

• Large scale bioreactor (2.5-50-250L scale) / multi-tray (Cell Factory/Cell Stack, Hyperstack configurations) mammalian cell culture
• Harvest and washing by continuous centrifugation technologies (e.g. kSep and LOVO) or batch centrifugation
• Concentration and washing with single-use Tangential Flow Filtration skids
• Purification by column chromatography and a Sepragen skid
• Final packaging including AT-closed cyclic olefin co-polymer plastic vials, or ISO 2R/6R/10R glass taking advantage of WB's validated Aseptic Fill services.

EV/Secretome Analytical Support

Custom and established analytical support for extracellular vesicles or mammalian cell secretome products include:

• Total protein by BCA (Bicinchroninic Acid) or UV (Ultraviolet) absorbance
• Sizing by nanosight
• Extracellular vesicle marker presence by ELISA
• Compendial tests including appearance, pH, endotoxin, bioburden, sterility
• Other capabilities shown in WB's Quality Control page

Example Experience

• Process development of exosomes purified from bone marrow Mesenchymal Stromal Cells
• Tech Transfer of Rooster Bio cell culture and downstream processes (see press release)
• Bacterial outer membrane vesicle product purified by size exclusion chromatography and concentration/buffer exchange by UF/DF (ultrafiltration/diafiltration) using single-use TFF (Tangential Flow Filtration)