As a CDMO our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class GMP manufacturing facilities to advance tomorrow’s medicines. For over 25 years our focus has been on supporting our customers with the development and manufacture of recombinant proteins, viral vaccines and gene therapies.
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.
- Extensive viral vector experience, including the process development, scale up and GMP production of: Adenovirus, Adeno-associated virus (AAV), Lentivirus, Poxvirus and Baculovirus among others.
- In-house developed Microbial (pAVEway™) and Mammalian (Apollo™ X) expression platforms
- Cell banking capabilities
- Full life-cycle biological and viral products manufacturing from initial concept to commercial product
- Analytical and Formulation Development Services for biologics, vaccines and advanced therapies
- Expertise in Process Characterization Studies with over 44 programs completed
Our cGMP Manufacturing Capabilities
- Cell Culture cGMP Manufacturing Capabilities ranging from 100L to multiple 2,000L
- Microbial Fermentation Manufacturing cGMP Capabilities ranging from 100L to multiple 5,000L.
- 20,000L large scale microbial production in collaboration with MSD
- Low dose biologics cGMP Manufacturing capabilities
- Gene Therapy and viral vector cGMP manufacturing facilities supporting production from pre-clinical to commercial production
Our network expands within four development and manufacturing facilities located in:
- Teesside, United Kingdom
- Research Triangle Park, North Carolina, USA
- College Station, Texas, USA
- Hillerød, Denmark
Our Track Record
- Licensed for the commercial production of 14 approved products
- Completed over 50 Process Characterization/ Process Validation programs
- Delivered over 2,500 cGMP batches
Committed to work in partnership with our customers along the clinical path
Our Platforms and Technologies:
- SaturnTM mAb Solutions for the efficient and de-risked delivery of Monoclonal Antibodies
- pAVEway™ microbial (E.coli) expression platform – process development and manufacturing
- Apollo™ X mammalian (CHO) expression platform – process development and manufacturing
- RAPTA – Statistical design tool for Laboratory Process Characterization (LPC) studies