Supporting Biotech and Pharmaceutical companies to take their product from Molecule to First in Human Trials
Biopharma Group is committed to delivering agile and flexible manufacturing solutions for the sterile aseptic production of liquid and lyophilized drug products. Backed by our state-of-the-art annex I compliant facilities and experienced team, we provide comprehensive services tailored to the specific needs of pharmaceutical and biotech companies worldwide.
Our services cover drug development and manufacturing for small molecule, large molecule, and advanced therapy products. We prioritize transparency and efficiency, ensuring seamless support for your project from molecule discovery through early-stage clinical trials.
Our facility in the UK has been specifically designed and optimized for small-scale batch manufacturing of Investigational Medicinal Products (IMPs). Our operations are semi-automated, enabling us to customize and control manufacturing processes according to your defined process requirements.
Supporting Clinical Developments – Our Services
- GMP Sterile Batch Manufacture of Lyophilised Products
- Sterile Fill and Finish
- High Potency/Cytotoxic API products
- Formulation Development (Pre-clinical and late phase scale up)
- Manufacturing process development
- Technical Transfer
- Analytical Method Development and Verification
- ICH Stability Studies
- Drug Product Release Testing
- Clinical Labelling and kitting
- Qualified Person Release
View our GMP Services Overview Here
Our Experience:
With over 35 years of experience in pharmaceutical formulation and process development, Biopharma group has worked on a range of product modalities, including:
Download a copy of our Pharmaceutical Services & Solutions overview brochure.
More Information
Our Clinical GMP Manufacturing Facility
- Uni-flow manufacturing design to minimise contamination risk.
- Negative pressure isolator designed for cytotoxic/highly potent API’s.
- ATS Hull S10 freeze dryer located within a negative pressure isolator, equipped with Sterilization in Place (SIP) capabilities. This system is further enhanced with CFR21 software for meticulous control and monitoring.
- Flexicon peristaltic semi-automated pump for liquid dispenses.
- Gas overlay capabilities.
- Dedicated storage areas for incoming, quarantined and released materials.
- In-facility cameras for remote observation of manufacturing processes.
Formulation and Process Development
- Material characterisation
- Lyophilisation cycle development or optimisation
- Formulation optimisation to suit both liquid and lyophilised drug formats for early-phase trials.
- Development of placebo formulations.
- Re-formulation and optimisation for late-phase scale up activities.
Preparation
Clinical Manufacturing Capabilities and Capacity
- Bulk lyophilisation up to 10.6L in Lyoguard trays.
- Lyophilised drug product in vials up to 3,200 vials per batch dependant on vial size.
- Sterile fill-finish into a range of primary vessels (batch sizes up to 5,000 vials per batch).
- Gas overlay capabilities.
- In-house final product release testing for lyophilised products
- Partner labs to support with analytical method development and ICH stability studies.
- Drug product release testing through in house capabilities and partner labs.
- In-house QP (Qualified Person) for fast product release
