R&D and Analytical Services for the Diagnostics Industry
Biopharma Group offers a range of research and development (R&D) and analytical services for diagnostics applications. With our long-standing experience in the industry, these specialist services enable you to develop cost-efficient, stable and robust formulations for your diagnostics and point-of-care products – in both liquid and freeze-dried formats.
We apply our team’s deep understanding of freeze-drying – including thermal and critical event analysis – to 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.
Applications for Diagnostics
Our team has worked on a diverse range of projects in the diagnostic products field in both lyocake and lyobead formats. This enables us to accommodate a host of applications, including:
Molecular Assays (Nucleic Acid-Based)
- PCR (Polymerase Chain Reaction)
- qPCR (Quantitative PCR)
- LAMP (Loop-mediated Isothermal Amplification)
- RT-PCR / RT-qPCR (Reverse Transcription PCR for RNA detection)
- NASBA (Nucleic Acid Sequence-Based Amplification)
Enzyme-Based Assays
- Enzymatic biosensors
- Substrate conversion assays
Point-of-Care / Rapid Diagnostics
- Lyophilized reagents for handheld diagnostic kits
Immunoassays
- ELISA (Enzyme-Linked Immunosorbent Assay)
- Lateral Flow Assays (LFAs) / Rapid Diagnostic Tests
- Multiplex immunoassays
- Fluorescence- or chemiluminescence-based antibody assays
Microbiological Assays
- Viability-based assays (bacteria, yeast, fungi)
- Enzymatic activity assays
- Antibiotic susceptibility tests (when reagents are included in lyophilized format)
Which Diagnostics Formats & Products Are Supported?
Biopharma Group has supported the development of numerous product types and formats including lyobeads.
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: Biopharma Group’s specialist 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 your product from early research to late-phase development.
Selecting the appropriate excipient and concentration is crucial for the long-term stability and mechanical strength of a freeze-dried product. This is particularly important for lyobeads, due to the handling steps involved in their development. If lyobeads lack mechanical robustness, there is an increased risk of bead breakage during handling. Our scientists specialize in developing robust freeze-dried formulations for the lyobead format, ensuring ease of handling and reliable pick-and-place processes. - 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.
