Xenova Biomanufacturing - Biologics Contract Development and Manufacture

Xenova Biomanufacturing is a contract-manufacturing organisation providing biologics development and manufacturing to the biopharmaceutical industry. We deliver your vaccines, therapeutic proteins and viral vectors from research, through process development and into manufacture, for phase I, II and III clinical trials.

Our team of highly-qualified and experienced scientists offer process and analytical development and the manufacture of a broad range of biological medicines, from therapeutic proteins to live viral products.

Our facility operates in compliance with the GMP expectations of both EU and US regulatory bodies. It has been issued a manufacturing licence by the MHRA and satisfies the manufacturing requirements of the EU clinical trials' directive.

We deliver your success through

• Quality: in our people, facilities and procedures
• Reliability: we consistently deliver to specification on time and within budget
• Experience: we have extensive expertise in the development and manufacture of a wide range of biologics for many biotech and pharma clients, and are proud of their record for repeat commissioning

EXTENSIVE BIOLOGICS DEVELOPMENT AND MANUFACTURE

On commissioning we establish project teams dedicated to resolving your particular development, process or manufacturing issues. Supported by commercial-level quality assurance and project-management staff, our service provides excellent and consistent value for money.

VACCINES, THERAPEUTIC PROTEINS AND VIRAL VECTORS

Xenova, a leader in the biotechnology sector for many years, has built up an impressive expertise in bringing vaccines, therapeutic proteins and viral vectors from research, through process-development, and into manufacture, for phase I, II and III clinical trials.

This expertise is offered commercially, as are the facilities we have developed. Our services are based on our thorough understanding of the issues that small companies and project teams face when taking a product through development into the clinic. We provide high-quality services, which are cost-effective yet flexible to your specific needs.

Development capabilities:

• Efficient and well developed project-management skills, together with a clear understanding of regulatory requirements
• Upstream and downstream process-development
• Analytical and formulation development
• Documentation development
• Effective process-transfer

Manufacturing capabilities:

• 11,000ft² clinical-trial manufacturing plant in the Cambridge Science Park, UK
• Two independent GMP suites for production of recombinant proteins and live vaccines (bacterial or viral)
• Cell growth up to 50L using mammalian, microbial and insect cells in suspension or micro-carrier culture
• Cell growth can be carried out in batch, fed-batch or perfusion culture
• Cell banking from cell line adaptation to cell bank preparation and storage
• Virus bank preparation and storage
• Product isolation and purification
• Aseptic filling into vials and ampoules
• On-site QC function undertakes a wide range of analytical assays
• Experienced, commercial level QA function

CONTRACT-MANUFACTURING FACILITIES

Xenova's contract-manufacturing facilities are modern, versatile and efficient. They comprise two independent suites, for protein as well as live virus-product manufacture, each with separate aseptic filling suites classified as class 100 / grade A / ISO class five. Our facilities are GMP-compliant, MHRA authorised for the manufacture of IMPs and meet the requirements of the United States FDA and the EU clinical trials' directive.

EXPERIENCE IN CLINICAL TRIALS

Xenova Biomanufacturing has an impressive track record of process innovation in the development, manufacture and quality control of products for clinical trials, across a wide range of product types, including recombinant proteins, conjugated vaccines, viruses and gene therapy vectors.