We are a world leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and advanced therapies.
With over 25 years of experience in process development and cGMP manufacturing, a dedicated staff of over 1,200 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.
Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.
Our network expands within three development and manufacturing facilities located in Billingham, United Kingdom, Redcar, United Kingdom, Research Triangle Park, North Carolina, USA, and College Station, Texas, USA.
We are licensed for the commercial manufacturing of six approved products.
Committed to work in partnership with our customers along the clinical path
Our Competencies and Capabilities
- Expertise with products expressed in a wide range of expression platforms including: microbial fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO , HEK, Vero, MDCK, EB66 and insect cells, and transgenics.
- In-house developed Microbial (pAVEway™) and mammalian (Apollo™) expression platforms
- Cell banking capabilities
- Full lifecycle biological and viral products manufacturing from initial concept to commercial product
- Center of excellence for Analytical and Formulation Development
- Cell Culture cGMP Manufacturing Capabilities ranging from 100L to multiple 2,000L
- Microbial Fermentation Manufacturing cGMP Capabilities ranging from 100L to multiple 5,000L
- High containment cGMP manufacturing capabilities (BSL2 and BSL3 capable)
- High Potency Biologics cGMP Manufacturing capabilities
- Center of Excellence for Process Characterization Studies
Our Platforms and Technologies:
- SaturnTM mAb Platform for the efficient and de-risked delivery of Monoclonal Antibodies
- pAVEway™ microbial (E.coli) expression platform – process development and manufacturing
- Apollo™ mammalian (CHO) expression platform – process development and manufacturing
- RAPTA – Statistical design tool for Laboratory Process Characterization (LPC) studies