Services and Products
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, frequently implementing Design of Experiment, enables our scientific team to collaboratively 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
- Pilot production of material that does not require CGMP compliance
- Process scale up prior to cleanroom production
- Process verification runs to confirm process robustness
- Formulation and stability studies
Process Development Laboratories
The Process Development labs are comprised of multiple rooms specifically designated for development and optimization of bacterial fermentation, mammalian cell culture, and downstream purification as applicable. 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
- Upstream Capabilities
- Pilot scale (2.5L) bioreactors with controlled feed readily scalable to larger 30L, 50L, and 250L counterparts
- T-flasks and single layer plasticware scalable to Cell Factory/Cell Stack, and Hyperstack configurations
- Cedex bioanalyzer for media analysis
- Downstream Capabilities
- ÄKTA and Sepragen chromatography systems
- High-throughput chromatography screening
- Pilot scale filtration and UF/DF systems
- Additional standard equipment includes: spectrophotometer, centrifuges, pH meter, temperature controlled shakers, tissue culture incubators, controlled rate freezers