R&D and Analytical Services for the Pharmaceutical Industry
Biopharma Group offers a range of research and development (R&D) and analytical services for pharma applications. With our long-standing experience in the industry, these specialist services enable you to develop cost-efficient, stable and robust formulations for your drug products – in both liquid and freeze-dried formats.
We apply our team’s deep understanding of freeze-drying – including thermal and critical event analysis – in all our services. This expertise is complemented by our facility’s advanced lyophilisation technology, which is used to rigorously examine the formulations that we develop. Through this approach, we ensure that your products meet the highest quality standards.
Expert Consultancy
Our expert scientific team provides tailored consultancy services that refine your formulations, internal processes, and future strategies. We deliver actionable insights that can be swiftly applied to improve your products and freeze-drying techniques.
R&D Services
Our R&D and analytical services support your formulation across all stages of its development – from initial product and process assessment to scale up and technical transfer.
- Product and process assessment: Biopharma Group characterises materials, reviews data, evaluates risk, audits your product’s freeze-drying cycle, and assesses its cost-efficiency. When completing material characterisation, we conduct pre-lyo analysis – using a Lyostat 5 freeze-drying microscopy (FDM) – to accurately identify key events and analyse the collapse temperature of your product. Additionally, the Lyotherm frozen state analyser is used at this stage, which enables quick and accurate measurement of glass transition, eutectic temperatures and melting temperatures before lyophilisation.
- Proof-of-concept studies: Proof-of-concept studies provide important insights into your product’s reliability, integrity and feasibility. To gather this data, we conduct a pilot lyophilisation cycle and complete further research on your product’s material characterisation. When compared with spray drying, oven drying and centrifugal drying for example, a lyophilisation cycle protects heat-sensitive drugs, reduces the risk of degradation, and improves product stability and solubility. By choosing proof-of-concept services, you can futureproof your approach from the outset, elevating product performance and avoiding potential delays.
- Formulation development: Our lab team develops your formulation, whether it is liquid, frozen, or lyophilised and carries out stability studies and testing to assess the quality of your product. Biopharma Group can support from early research to late-phase development.
- Scale up: Our experts prepare your freeze-dried or liquid product for full-scale production. During this stage, the team develops technical approaches that improve your product’s scalability.
- Troubleshooting: To increase your product’s resilience – both physically and commercially – Biopharma Group also offers troubleshooting services including root cause analysis, consultancy, and additional risk assessments should you need them. This is offered on completion of the formulation and process development phase to provide full assurance.
- Technical transfer to production facilities: Whether your product is liquid or lyophilised, we support in the tech transfer of your manufacturing process to your other sites or to us.
Specialist Analytical Services
Biopharma Group offers specialist analytical services that optimise your product’s development. These include:
- Preformulation studies and early formulation screening
- Comparability studies
- Stability studies
- Assay testing (HPLC)
- Forced degradation studies
- Particle characterisation:
- Light obscuration
- Micro-flow imaging
- Particle identification
- Surfactant characterisation
- Chemical change analysis
- Cycle development
Lyophilisation Analytical Services
Analytical services for liquid or solid formulations:
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- Headspace moisture analysis (HMA)
- Freeze-drying microscopy (FDM)
- Lyotherm analysis (DTA + Electrical impedance)
- Differential scanning calorimetry (DSC)
- Gas adsorption analysis
- Scanning electron microscopy (SEM)
- X-ray powder diffraction (XRD)
- MicroPress testing for mechanical properties
- Friability testing
- Visual assessment
- Reconstitution testing
- pH testing
- Osmolarity testing
- Dynamic Vapour Sorption (DVS)
Support of Product Types
A broad range of experience in this area also allows support of the following product types:
- Antibiotics
- Radiopharmaceuticals
- Hormones
- Peptides
- Cells and stem cells
- Human and animal tissues
- Collagen
- Plasma derivate product and blood factors
- Microbiome
- Probiotics
- Aerobic and anaerobic bacteria
