Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs. From the lab to the market, we take your idea to the FDA and EMA for approval. With over 300 innovative biotechnology and pharmaceutical clients, Team Coté is led by Dr. Tim Coté, the former Director of the FDA’s Office of Orphan Products Development (OOPD).
DNAtrix is a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer.The company’s initial focus is on glioblastoma, a devastating brain tumor that is resistant to conventional therapies. DNAtrix’s lead product, DNX-2401, is a modified common cold virus that targets and kills cancer cells selectively. [Read more…]
Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S.
Working as an outsourcing partner, and with a long-standing tradition of quality and service, Paragon expands the capabilities of pharmaceutical companies, biotechnology companies and academic laboratories involved in identifying, developing and producing monoclonal antibodies, therapeutic proteins, disease biomarkers, vaccines and reagents for diagnostics… [Read more…]
FUJIFILM Diosynth Biotechnologies is a dedicated biopharmaceutical CDMO business with development and manufacturing sites in Billingham, UK and Research Triangle Park, North Carolina, USA, and College Station, TX, USA employing over 1000 staff. Globally we have over 30 years of clinical and commercial experience in biopharmaceutical development and cGMP manufacturing.
Vibalogics is a Contract Manufacturing Organisation (CMO) offering process development, cGMP manufacturing and fill/finish of products based on viruses and live bacteria for companies involved in the development of vaccines, gene and oncolytic viral therapies in the biopharmaceutical industry.
Vibalogics services include: Feasibility assessment; Technology transfer; Process development; cGMP manufacturing; Formulation; Fill/finish of liquid & lyophilized formulations; QC analysis; Product release.