Dependable, flexible and efficient, BPDF’s purification development group develops and optimizes robust and scalable purification processes suitable for GMP production. Our experienced scientific staff utilizes state of the art tools and a design of experiments (DOE) approach for timely and efficient process development. Development typically involves application of various column chromatography chemistries and tangential flow filtration (TFF) to achieve the level of quality and quantity specified by our client. Our staff has a strong knowledge of purifying proteins from various expression systems either secreted or intracellular, and soluble or inclusion body forms.
- Experience purifying vaccines, chemokines, interferons, fusion proteins, Fabs, enzymes, and other biomolecules
- Knowledge of large scale processing is applied to process development, avoiding time consuming scale-up challenges
- Documentation of engineering runs, confirming the developed process, via production batch records, facilitating successful technology transfer
- Evaluation of in-process hold steps, product formulation, and initial stability testing.