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GMP Freeze Drying Clinical Manufacture Facility – For Your Early Phase, First-in-Human Clinical Trials - Contact Us Today
Biopharma Group provides a wide range of services and innovative solutions, spanning from GMP production to liquid and lyophilized formulation development, and more, tailored to meet the precise needs of the biopharmaceutical industry.
Biopharma Group stands as a dynamic and versatile CDMO partner in the pharmaceutical industry, offering comprehensive R&D and manufacturing services. Our commitment to Quality by Design (QbD) and Design of Experiment (DoE) methodologies drives innovative and efficient drug formulation and lyophilisation process optimisation.
Biopharma Group’s Annex 1 compliant, GMP (Good Manufacturing Practice) freeze drying production facility supports partners with the transition of their product from the R&D phase to clinical manufacture. The UK based facility has been designed to accommodate small batch manufacture of both cyto and non-cytotoxic products for first-in-human (FIH) trials to offer access to fast, efficient GMP manufacturing paired with flexible manufacturing solutions.
Tackling issues like poor shelf life, cold chain supply, or product performance? Biopharma Group's diagnostic R&D to manufacturing services offer trouble-shooting solutions for those dveloping diagnostic reagents, including process audits, product & cycle development, optimisation, and reformulation. We operate a full custom packing facility, capable of handling individual kits to final shipper cartons. With secure worldwide shipping expertise spanning temperatures from -80oC to ambient, you can trust us to handle your samples correctly at every stage.
Biopharma Group has extensive experience in handling cytotoxic and sensitive HPAPI samples, ensuring the safety of all involved and maintaining product integrity. With a strong focus on containment and protection procedures, we provide the expertise needed to process cytotoxic compounds with rigorous safety measures.
Biopharma Group takes pride in having developed its advanced analytical lyophilization instruments, including the Lyostat freeze-drying microscope (FDM), Lyotherm DTA and impedance analyser, MicroPress and the new LyobeadPRO lyobead generator. These innovative tools have been meticulously designed to support professionals engaged in freeze-drying technologies for both production and research projects. As a testament to our commitment to excellence, we continuously enhance and update these instruments to provide cutting-edge solutions to meet the evolving demands of the industry.
Biopharma Group offers comprehensive lyophilization training courses designed to guide you on the principles of lyophilization processes. These courses cover a wide range of topics, including theory, practical applications, best practices and troubleshooting techniques. Whether you are new to lyophilization or seeking to enhance your existing skills, our training courses provide valuable insights and hands-on experience at our site in Winchester, UK, your site, via online webinars or pre-recorded eLearning modules.
Biopharma Group endeavors to support international customers by offering contract research and development services for dried product and liquid formulation analysis. All performed within our in-house lab, our team of scientists also have the capabilities to provide comprehensive manufacturing services for the freeze-drying stages of diagnostic & vaccine production.
Get to know our board of highly-experienced directors – responsible for the trusted reputation of Biopharma Group - who are dedicated to providing flexible, customised CDMO solutions and services in a confidential, safe, and industry compliant manner.
From their scientific specialisms to their roles at Biopharma Group, learn more about the individuals that work to offer customer-centric CDMO services.
Overview
Pharma CDMO Services
GMP Production
Diagnostic CDMO Services
Cytotoxic & High Potency Samples Handling/ Processing
Analytical Lyo Instruments
Lyophilization Training Courses
Freeze Dryers
Pharma & Biotech Freeze Dryers
Food Production Freeze Dryers
Fill-Inish Solutions & Processing Lines Equipment
Cryopreservation Storage Equipment
Faster Airflow Equipment
Centrifugal Solvent Evaporation Systems
High Pressure Homogenisers & Liposome Extruders
[email protected] | +44 (0)1962 841092
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