Process Development

At Waisman Biomanufacturing we recognize that every project is unique and we work closely with clients to transition a non-cGMP benchtop protocol into a fully scalable, reproducible, cGMP compliant process. Our solution-oriented strategy enables our scientific team to identify and resolve technical issues in a time and cost effective manner. This approach expedites the translation of your process technology, streamlining the move of your project from cleanroom to clinic.


PD Laboratory Services

• Production of research grade material that does not require cGMP status
• Process scale up prior to cleanroom production
• Process verification runs to confirm process robustness
• Formulation and stability studies
• Standalone research and development

Process Development Laboratories

Many manufacturing campaigns start in the Process Development Labs and accordingly, this space is in frequent use. The PD labs are comprised of three separate rooms.  Two rooms are specifically designated for mammalian tissue culture and the third is used for bacterial culture, buffer prep and chromatography purposes. It has been our experience that time and effort spent to establish a well defined protocol in the Process Development Labs results in a smooth and efficient transition into the cleanroom.

Equipment

• Class II Type B3 biosafety cabinets
• New Brunswick Bioflo 3000 fermentors (4 L capacity)

• Pilot scale (2.5L) bioreactors with the same control as the 50L and 250L counterparts
• GE Health Care ÄKTA column purification system
• UVP Gel documentation station
• Standard equipment includes: spectrophotometer, centrifuges, pH meter, temperature controlled shakers, tissue culture incubators, refrigerator and freezer storage