Category: Contract Research & Manufacturing
Phone: + () 617.401.8030
Fax: + () 617-401-8031
Location: Woburn, MA
Therapeutic Areas: Cancer/Oncology, Dermatology, Ophthalmology
Upstream Process – Cell Culture and Methods Development
Cell culture technology transfer will begin with the expansion of a RCB to produce a WRCB and confirm media and procedures for viable cell density, doubling time and split ratios in small shaken cultures. During this activity, procedures for counting cells and expansion methods of the seed train for manufacturing will be established. The fed batch process will be confirmed in small shaken cultures to test the WRCB and fed batch culture process. Bench-top bioreactors will be used to confirm and finalize the fed batch process.
The culture method will be tested for scale up using a 2L Applikon vessel to a 10L Rocker bag and finally to our 50L Single Use HyClone Bioreactor using Delta Software from Finesse. A minimum of two (2) successful runs for each reactor scale will be performed. Material produced in this phase of the project will be used to confirm downstream processing methods and for reference standard preparation and characterization.
Downstream process – Purification Methods
In collaboration with Pall Corporation, material produced above will be used to confirm the purification process and the purity and quality of the resulting product. Protein prepared in these early experiments will be used to qualify existing lot release assays and to develop protein specific potency assays. These small-scale purification runs will be done to confirm aspects of the purification process such as resin capacity, buffer volumes for wash/elution steps and product recovery.
The small scale purifications will provide background information for scale down modeling for future viral inactivation experiments. Key process intermediates will be frozen and tested for particles, SEC-HPLC and CIEF to confirm stability of frozen in-process intermediates intended for viral inactivation studies.