Name: Biovolutions
Address: 1 Presidential Way # 108, Woburn, MA, 01801-1071, USA
Telephone: (617) 401-8030

Cell Culture Process Development

Our development efforts for cell culture and purification and to confirm performance at intermediate manufacturing scale will begin upon receipt of the following:

•Draft product specifications for key process intermediates
•Extinction coefficient of the MAb
•RCB
•Raw materials list for cell culture and purification
•Cell culture media and methods for upstream processing
•Purification methods for downstream processing
•Product specific potency (ELISA) analytical method
Upstream Process – Cell Culture media 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 3L New Brunswick vessel and finally to our 50L Single Use HyClone Bioreactor. 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

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.
The purification of protein from the 50L will produce approximately 25 g of GLP material. A portion of the final formulated material will be dispensed in 200µL aliquots and frozen at -80°C and will be used to prepare the reference standard. The remaining material will be filled in 10 ml vials. The vialed material would be suitable for use in preclinical stability testing, product characterization or toxicology studies.

Biovolutions

Business Info

Contact Business

Company Summary

Similar Businesses Nearby

Competitive Landscape

Payments Accepted

Hours

Photos

Business Credit Report

Facebook

Twitter

Yelp

Customer Resources

Our Company

Our Network

Site Links