The clinical and commercial success of biotherapeutics hinges upon the development of robust and scaleable processes. The final process must provide the active pharmaceutical ingredient at the specified purity and meet safety, in-vivo potency and pharmacokinetics requirements. Furthermore, the process documentation must allow for rapid transfer from development to manufacturing, and the process must be easily scaleable in the environment of a typical biopharma manufacturing facility.

The intricacies of cGMP manufacturing must be carefully considered early in the development process so that the product proceeds smoothly into clinical and commercial manufacturing. A seasoned process development team evaluates the options and delivers processes that drive therapeutics into Phase I trials quickly with a seamless transition to later stage and larger scale production.

Process Development Services
A multidisciplinary team, experienced in meeting the challenges of successful process development, will combine technical skills and relevant experience including:
1) development of robust cell culture and fermentation processes
2) scaleable harvest and recovery procedures
3) well-designed, high-yield purification steps, and
4) rugged analytical methods suitable for validation.

Looking for information on Fermentation Development and other related resources?

Cell Culture capabilities include:
• Selection of clones
• Cell line evaluation and adaptation, with expertise in numerous mammalian systems, yeast, pichia, bacteria, insect, etc.
• Media development
• Development of nutrient feed strategies to prolong culture life and production
• Optimization of existing processes
• Identification of critical process parameters
• Development of process control strategies
• Production at pilot scale for preclinical studies (Phase 1 cGMP production is under development)
• Process cost analysis

Harvest, recovery and purification capabilities include:
• Centrifugation, tangential flow filtration and dead-end filtration
• Product capture by expanded bed and traditional chromatography
• Anion and cation exchange chromatography
• Hydrophobic interaction chromatography
• Reverse phase chromatography
• Viral inactivation and filtration processes
• A biophysical approach to purification development to ensure conformational stability and optimal biological activity