Biopharma Technology LLC’s R&D and analytical lab services for the diagnostics industry enable you to solve complex lyophilization challenges, while optimizing your lyophilized and liquid formulations. Framed on Quality by Design (QbD) and Design of Experiment (DoE) principles, these elevate the quality and cost-efficiency of your products.
Analytical Lab Services For Diagnostics
Working from our laboratory in Carlsbad, California, we provide analytical lab services that support all stages of your formulation’s development and drive increased product performance. These include:
- Product and process assessment: We anticipate return on investment, characterize materials, review data, assess risk, and audit your product’s lyophilization cycle.
- Proof-of-concept studies: Our team completes a trial lyophilization cycle and carries out further research on your product’s material characterization.
- Formulation and cycle development: Using a QbD and DoE methodology, we develop your formulation and carry out stability studies. We also construct the process design space at this stage.
- Scale up and technical transfer: We manage the process of preparing the product for scaled production, while developing technical approaches that boost its scalability.
- Troubleshooting: Our scientists provide remote formulation and process development to future-proof your product. Root cause analysis, consultancy, and further risk assessments are also delivered.
- Technical transfer to production facilities: We complete a feasibility lyophilization cycle and prepare your products for manufacturing.
Process Analytical Technology Services
Biopharma Technology LLC’s selection of advanced analytical tools are available to support you across all phases of your product’s development:
Pre-lyo analysis:
- Lyostat freeze-drying microscopy (FDM): Through lyophilization (aka freeze-drying) microscopy, Biopharma Technology LLC can accurately identify and log the key events and collapse temperatures of your products.
- Lyotherm frozen state analyzer: By combining electrical and thermal techniques, this allows for two analyses to be conducted at the same time, enabling the measurement of glass transition, eutectic temperatures and melting temperatures to be swiftly and accurately completed before lyophilization.
Post-lyo analysis:
- MicroPress post-lyo process assessments: This is used as part of the post-lyo analysis to determine the mechanical properties of lyocakes and lyobeads. This measures the strength and durability of products to ensure that they can be safely handled and shipped.
- Karl Fischer titration: This measures residual moisture content after lyophilization to provide reliable quality control.
Collaborative Research Services
In addition to co-producing new products, Biopharma Technology LLC collaborates with industry partners to develop new lyophilization methods, applications, and innovations. These projects include:
- Developing Lyophilized Diagnostic Tests
- Lyophilizing Human Blood for Long-term Storage
- Lyophilization of Collagen Matrices for Regenerative Cartilage Repair
Biopharma Technology LLC also delivers lyobead development services for its customers by applying its expertise as one of the industry’s leading innovators in this technology. Lyobeads are lyophilized spheres of material that are created through rapid freezing. The advantage of using lyobeads is that they have a larger surface area than traditional lyocakes, which results in a significantly faster reconstitution process.
