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 to Clinical Manufacturing Workflow for Lyophilised & Liquid Products
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
Customer Testimonials
“We are very grateful for our collaboration with Biopharma Group and for their valuable help in the development of our lyophilization process. Their expertise and commitment played an important role in achieving results that exceeded our expectations. As a testament to our joint effort, we launched our first lyo-compatible qPCR mix - SolisFAST® Lyo- Ready qPCR Kit with UNG. We appreciate their genuine dedication to our project and look forward to continued success together.”
“Through my experience of working with Biopharma Group on various lyo projects, I can happily say that I have always been super impressed with the results that we have received! We will definitely continue to make Biopharma Group our first choice when needing to outsource freeze drying support.”
We have had the opportunity to work with Biopharma Group on several projects to optimize and improve freeze-drying processes. Biopharma Group has real expertise that is put to the benefit of its customers. The responsiveness of their teams and the tools used have always been highly appreciated.
We worked with Biopharma group very intensively around Lyo project development. I was very much impressed and enjoyed working with the team that provided detailed, and regular updates on project progress, challenges, and solutions.
The information provided by the Biopharma Group team helped me to improve the quality of our product, and in particular helped me to develop more effective and efficient processes for transferring our products from research to the production stage.
Theragenix has benefited from Biopharma Group services to develop a formulation suitable for lyophilisation. The project involved a freeze drying cycle and a series of analyses for stability studies. Both technical and commercial support has been very appreciated
“Thank you for being so professional, helpful, innovative and friendly. We were extremely impressed with the quality of your service.”
“We elected to work with Biopharma because of their full service and years of experience. They helped us with analysis and troubleshooting of our product and we were impressed by the quality and responsiveness of their scientists. We would definitely use them again.”
“Biopharma developed a successful cycle for us, their quality and technical support was excellent.”
“Biopharma helped develop our cycle, we are extremely satisfied with their quality and service and would thoroughly recommend them to others.”
“Biopharma Group quickly understood our radiopharmaceutical challenges and provided effective solutions. Their team is highly responsive, knowledgeable, and a pleasure to work with.”
“We chose Biopharma because of their reputation and expertise in the field of lyophilisation and we were impressed with their overall excellent level of service. We would recommend them.”
"Biopharma Group always offered fast and reliable results in our Freeze Dry Microscopy studies. Big thanks for a great team!"
“We worked with Biopharma Group for the development and deployment of an antibody freeze drying process to support preclinical studies. They rapidly provided technical insights to guide the design of the process development study and helped troubleshoot unexpected results. The team’s experience was critical to the success of this project, and we benefitted from an open and collaborative approach throughout.”
