R&D / Analytical Services
Biopharma Group offers an extensive selection of research and development (R&D) and analytical services for organisations that develop diagnostic reagents. These services are framed on our in-depth expertise in thermal and critical event analysis techniques, as well as our facility’s range of advanced equipment types. Developed inhouse, we use our Lyostat freeze-drying microscopy (FDM) and Lyotherm frozen state analyser to conduct a rigorous analysis of your liquid and freeze-dried product formulations. This approach provides you with a comprehensive understanding of your product’s quality, stability and solubility.
Informed by Quality by Design (QbD) and Design of Experiment (DoE) principles, our expert scientific team is equipped to assist you in resolving the diagnostics industry’s most complex lyophilisation challenges, while optimising the performance and cost-efficiency of your products.
We can also support your team in building efficient product development processes for your formulations. This helps to future proof your products by ensuring that they are fully prepared for scale up and market launch.
Process Analytical
Technology Services
Biopharma Group’s team – and our advanced lyo analysis instruments – are on hand to provide quality assurance across all phases of your product’s development:
Pre-lyo analysis:
- Lyostat freeze-drying microscopy (FDM): Through FDM, we can precisely identify and log the key events and collapse temperatures of your products using our proprietary Lyostat 5 technology.
- Lyotherm frozen state analyser: Enabling two analyses to be conducted at the same time, this approach combines electrical and thermal techniques to swiftly and accurately measure glass transition, eutectic temperatures and melting temperatures before lyophilisation.
Post-lyo analysis:
- MicroPress post-lyo process assessments: Our MicroPress technology is used during post-lyo analysis to understand the mechanical properties of lyocakes and lyobeads. This approach ensures that products can be safely handled and shipped by assessing their strength and durability.
- Karl Fischer titration: This quality control technique measures residual moisture content after freeze-drying, allowing us to verify that your products meet your exact specifications. We can also complete Dynamic Vapor Sorption (DVS) to understand the moisture sorption properties of materials.
Analytical
Lab Services
We offer analytical lab services that de-risk your formulation’s development process, while enhancing its performance. These include:
- Product and process assessment: We assess return on investment, characterise materials, review data, evaluate risk, and audit your product’s lyophilisation cycle.
- Proof-of-concept studies: We complete a pilot lyophilisation cycle and conduct further research on your product’s material characterisation. This sets out the most reliable and efficient method for achieving your product development aims.
- Formulation and cycle development: We develop your formulation and carry out stability studies using a robust QbD and DoE methodology.
- Scale up: We manage the process of preparing your product for full-scale production and develop technical approaches that enhance its scalability.
- Troubleshooting: Our freeze-drying experts conduct formulation and process development to ensure that your product is future-ready. Root cause analysis, consultancy, and further risk assessments are also completed.
- Technical transfer to production facilities: We deliver a feasibility lyophilisation cycle and prepare your product for manufacturing.
Collaborative
Research Services
Biopharma Group co-develops new lyophilisation methods, applications, prototypes and innovations with our industry partners. Some of the projects that we have supported include:
- Developing lyophilised diagnostic tests
- Freeze-drying human blood for long-term storage
- Freeze-drying collagen matrices for regenerative cartilage repair
As one of the leading innovators in lyobead technology, we also offer lyobead development services for our customers. Lyobeads – otherwise known as freeze-dried beads or lyophilised spheres – are rapidly freeze-dried products. To create lyobeads, we use liquid nitrogen (LN²) or polymeric gelation to generate a spherical format. With their reproducible dosage and faster reconstitution properties, opting for a lyobead-based approach can help you to accelerate your lyophilisation project timescales.