BLAs + Master Files
Cell / Gene
FDA’s approval of Amgen’s Mvasi, a biosimilar version of Roche’s Avastin, illustrates the ongoing contradiction of large biotech an...
"BPTC’s expert help in auditing our Indian manufacturing partner and writing our first regulatory filing was instrumental in launching our first cGMP-manufactured product. The BPTC team ensured preparation of an excellent Master File under aggressive timelines."
"When BPTC is involved in the CMC development programs of our early stage customers, they are able to provide real-world CMC development experience and expertise that streamlines the development and enables our customers to make knowledge-based strategic decisions based on data and regulatory mandates."
"The breadth of expertise in all areas of process development and manufacturing of antibodies and peptides was invaluable to our company in prioritizing our development activities and planning for future expenditures to advance our cutting edge oncology product towards the clinic."
"BioProcess Technology Consultants provided invaluable help in the development of our lead product TT-173. Their experience and professionalism helped our Company detect deficiencies and solve them in an efficient and timely manner with significant cost savings. We continue to use BPTC's services, and will contract them in future projects."
"BPTC’s extensive knowledge and experience in the development and commercialization of biologic products has been invaluable to The Medicines Company. They have helped us develop strategic manufacturing and pharmaceutical development plans, as well as applying their extensive industry knowledge to identify and evaluate appropriate contract manufacturing partners."