Augmenting your in-house expertise to achieve successful project & product results every time.
Areas of Expertise
in Freeze Drying
Expert CDMO Services for Dried Product & Liquid Formulations
Supporting international customers, Biopharma Group has a dedicated in-house lab & scientists based in Winchester, UK offering contract research for dried product and liquid formulation analysis. Additionally, there are over 15 freeze dryers on site to provide manufacturing services for the freeze drying stages of diagnostic & vaccine production, along with spray drying processing for suitable products. In Q4 2023, a new GMP facility will provide freeze drying for up to 3,200 2R vials, along with full isolation facilities in a grade A cleanroom environment for sterile production of both liquid and lyophilised products to pharmaceutical companies needing small batch production facilities for first-in-human trials.
The contract R&D services cover pre- and post- lyophilisation or spray drying testing, including pre-process comparable trial cycles to establish the best processing method for your product. Additionally, we have process analytical technology (PAT) incorporated within our freeze dryers for real-time data generation whether this be for pharmaceuticals, biotech products, diagnostics production through to specialist papers & organic materials. The range of services include pre-formulation studies & formulation development, cycle development, process reviews, product characterization, sample production (including IVDs & vaccines) through to scale-up/optimization and specialist post-process analysis such as Dynamic Vapour Sorption (DVS) and mechanical structure analysis of lyocakes and lyobeads using the MicroPress.
We also have a Class 7 cytotoxic handling facility available, allowing us to assist in cytotoxic, high potency and sensitive sample product development and processing. Contact our specialists to discover more.
Lyo Training Courses
For those who have their own freeze drying facilities, making sure that staff are up to date with the most current techniques, best practices and industry developments is key to ongoing success. Biopharma Group offers expert led freeze drying training courses, in the form of scheduled training courses across the UK, Europe and North America, customised on-site training catered to your specific requirements, live webinars, customised webinars, pre-recorded eLearning video modules along with our L6 course, accredited by the University of Limerick.
Process & Cycle Development
R&D and Troubleshooting
(Dedicated Team of Freeze Drying Specialists & ScientistS)
Cycle Audit and Regulatory Support
New Product Development
Collaborative R&D Services
Variable and Phased Scale Production
End-to-End Process Support
Lyo Training Courses
Design and Development of Proprietary Analytical Technology
In-House Technical Service Team
Support to Global Pharma, Biotech and Diagnostics Industries
Flexibility to Handle Project Changes
Dedicated Project and Account Managers
30+ Years Operational Experience
100+ Years of Combined Industry Expertise
KEY BENEFITS OF USING BIOPHARMA GROUP
CONTRACT RESEARCH & MANUFACTURING
Biopharma Group’s R&D consultancy and lab services division has over twenty years’ experience in freeze drying research and development.
Our expertise includes characterisation services, formulation development, cycle development and post process analysis. We have developed efficient and robust cycles for a wide varietyof products including foods, small molecules, diagnostic reagents and biological materials such as bacteria, viruses and blood products.
Biopharma Group runs scheduled and customised training courses on freeze drying technology and applications with highly experienced lecturers, during which we demonstrate how to use our machines*.
Additionally, our experts have products pre-recorded video modules that are available to purchase as budnles or indivually, and a micro-couse accredited by University of Limerick
*Winchester Training Courses
INSTALLATION & USER TRAINING
Installation and training packages are available for new and existing systems. The two-day service includes testing the equipment to ensure it is performing to specifications and explanation and demonstration of use. Unlike other suppliers, all our installation and training is carried out by scientists with practical, first-hand experience of the systems and interpretation of data.
MAINTENANCE & REQUALIFICATION
In order to ensure continued smooth and precise operation of your instruments we recommend that maintenance is carried out every year. Re-qualification can also be carried out to provide evidence of the accuracy of the data. Re-training is especially recommended when purchasing an upgrade or new accessories.
Contract Research Services
The unique characteristics of each product type, formulation and application mean that every project presents a different and new set of challenges. When you entrust your project to Biopharma Group you benefit not only from our many years of experience but also the breadth and depth of cumulative knowledge. In combining sophisticated analytical techniques with this in-depth knowledge, we ensure your freeze drying project progresses smoothly.
Main Contract Research & Analysis Services:
• Proof of Concept Studies
• Formulation Development for Liquid and Dried Products
• Process Development
• Freeze Drying Design Space & Trial Cycles
• Development of Freeze Dryable Spheres (Lyobeads)
• Product Characterisation (pre- / post- freeze drying)
• Controlled Nucleation
• Stability Studies
• Freeze Drying vs Spray Drying – Comparative Studies
• Dedicated Cytotoxic Facility for High Potency & Sensitive Samples Handling/Processing
• Diagnostics Production
• End-to-End R&D to Early Phase Clinical Trials Production
Key Benefits of Using Biopharma Group as your CRO Partner for Lyophilised Products:
• Optimise your Original Lyophilisation Cycle
• Dedicated Project & Account Managers
• 30+ Years Experience in Operational Freeze Drying
• Multi-disciplined, In-house Team of Specialists & Scientists with 100+ Years of Industry Expertise
• In-Depth Knowledge & Skills to Help Achieve your Long-term Production Goals
DECADES OF PRACTICAL PROCESS EXPERIENCE
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.
I worked with BTL and they provided an excellent service to Waters at the development phase of our project.
Both Dr. Laura Ciccolini and Mr. Nick White were very helpful and professional, [they] not only assisted me with the project but also gave me an understanding of the Freeze Drying process. The personnel at BTL are the experts in their field of freeze drying and really supportive to me as a client in our development phase and were really focused in adding value and optimising the process throughout.
I would highly recommend BTL for all Freeze Drying project and would 100% use them again.
…fast response to customer requests and provision of a quote.
Even though we had delays in confirming the order and providing the samples to btl, the analysis was conducted immediately and results provided swiftly, which is very helpful for a CMO like Vibalogics to keep our customers satisfied.
We are outsourcing our product for testing often[…] and getting the satisfactory results from [Biopharma] the company; also availing the additional benefits. We [are] assured to continue the same rapport with your esteemed organization. Thank you for your timely support. It’s our pleasure to outsource the products for testing with [your] esteemed and well established organization.