Purification & Technology Transfer

Purification

Our purification scientists design and develop recovery and purification processes to meet quality and purity standards. Development objectives include:

Cost-effective and efficient processes
High yields
Compatible in a cGMP environment

We've developed processes for a wide variety of recombinant protein and peptide products using both high and low pressure chromatography techniques and a wide range of filtration technologies.
Protein Classes include:

MAbs
Hormones
Cytokines
Toxins
Transcription factors
Enzymes
Anticoagulants
Fusion proteins
Therapeutic vaccines

Recovery steps typically feature either centrifugation or filtration. Purification process steps routinely developed and operated at Diosynth Biotechnology include:

Reverse phase chromatography
Size-exclusion chromatography
Ion exchange chromatography
Hydrophobic interaction chromatography
Affinity chromatography
Expanded bed chromatography

Purification also uses a variety of filtration methods. These include:

Ultra/diafiltration
Microfiltration
Tangential flow filtration

Our team is also experienced in refolding processes and post expression modifications such as PEGylation.

Our purification scale is compatible with cell culture and fermentation. We also conduct analytical testing to support development and can develop a scaled-down model to support viral clearance studies.

Technology Transfer

Diosynth Biotechnology's process development group has unparalleled experience in transferring processes from customer facilities into our facilities and in transitioning developed processes from laboratory and pilot facilities into our cGMP manufacturing facilities. Processes successfully transferred range from bench-scale "research" processes through processes for products already on the market.

See also