Pharmaceutical Clinical Manufacturing Services
Launching pharmaceuticals to market is a highly complex and safety-critical process. When manufacturing these products, pharmaceutical organisations need to keep pace with sharp timescales and evolving regulatory frameworks, while maintaining the highest levels of quality.
By working with Biopharma Group, you can navigate these challenges with full assurance. Specialising in clinical manufacturing batches, our expert team offers flexible and scalable solutions that are tailored to your exact R&D and manufacturing requirements. This accelerates your freeze-dried or liquid product’s market readiness, enabling you to focus on connecting patients with the medicines they need most.
Biopharma Group’s services support all phases of the manufacturing process, from technical transfer and engineering batch production to clinical manufacturing, packing, handling and shipping. Our team ensures that each of these stages are completed according to Annex 1 of GMP (Good Manufacturing Practice) standards, while optimising your product and processes along the way. This sets the foundations for a safe, efficient and cost-effective commercial launch, future-proofing your product.
Our Manufacturing Approach
Once your product has progressed beyond research and development (R&D) – which Biopharma Group can also support through our formulation and lyophilisation centre – our expert team is on hand to manage the next stage of its launch: clinical manufacturing.
Biopharma Group accommodates all stages of the manufacturing process and can handle substances classified up to OEB 6 (occupational exposure band 6):
Why Choose Biopharma Group?
Established in 1989, Biopharma Group has specialised in developing freeze-dried and liquid formulations for over 35 years. During this time, we have delivered over 4,000 projects across 30 countries globally. We combine this long-standing experience with our deep domain expertise in manufacturing lyophilised products. Biopharma Group’s scientific team applies this experience to your product’s manufacturing process, supporting its swift, safe and cost-efficient launch.
By collaborating with Biopharma Group, your operations benefit from:
- Freeze-drying expertise: Our lyophilisation experts are available throughout the entire clinical manufacturing process, offering technical transfer support and troubleshooting guidance.
- Specialised facilities for OEB 6: With Biopharma Group’s advanced facilities, our team can handle substances classified up to OEB 6 (occupational exposure band 6) – the highest classification for hazardous substances.
- Sterile fill and finish: All products that Biopharma Group manufactures are filled and sealed under aseptic conditions.
- Minimised costs: Biopharma Group’s facility is designed for the specific requirements of small-scale production, allowing us to offer competitive pricing
- Flexible manufacturing: Biopharma Group’s solutions answer the unique needs of your project. We can support a wide range of project scopes and scales – with no minimum batch size.
- Accelerated timescales: We provide quick access to a manufacturing slot at our production facility, helping you to get your products into clinic on time.
- Expert regulatory support: Our expert team has an in-depth understanding of the latest industry regulations and standards – including Annex 1 of GMP guidelines – ensuring that your product is manufactured in full compliance with these.
- Qualified Person product certification: We offer Qualified Person (QP) batch oversight and certification as part of our services, enabling rapid release to clinic.
- An all-in-one solution: By choosing Biopharma Group, you can complete your R&D and early phase clinical manufacturing operations all in one place, streamlining your product development plans.
