XenovaBio manufacturing capabilities

Manufacturing Capabilities
Over the past ten years, Xenova (formerly Cantab) has built up considerable expertise in the GMP manufacture of products for Phase I, II and III clinical trials. Xenova has a successful track record in biologics manufacture across a wide range of product types, including recombinant proteins, viruses and gene therapy vectors

	Key Features.

	11,000 sq. ft. manufacturing plant on Cambridge Science Park
	Our facility is GMP compliant, MHRA authorised and meets the requirements of the US FDA and EU Clinical Trials Directives. Cambridge Science Park has excellent road, rail and air links to the rest of the UK, Europe and the US.

	Two independent GMP suites
	Our facility features two compliant suites allowing the manufacture of both recombinant proteins and live bacterial and viral vaccines.

	Cell growth up to 50 litre scale
	Production capability using bacterial or animal cells, in free suspension or on microcarriers, designed and scaled to match your project needs.


	Mammalian, bacterial and insect cells
	Cells can be grown in batch and perfusion cultures with a capacity of up to 100 roller bottles.

	Cell banking from creation of cell lines to cell bank preparation and storage
	From the creation of cell lines, we are experienced in adapting cell lines to serum-free and protein-free, to cell bank preparation in suitable freezing mixtures, and to long term assured cryogenic storage.

	Product Isolation and Purification
	Downstream capability using chromatographic columns from 10mL to 50L, and membrane technologies from 50cm² to 2.5m²; we also have significant experience of virus removal operations for protein therapeutics; and aseptic processing for live virus products.

	Filling into vials and ampoules
	Clinical trial supplies can be filled into vials or ampoules, suitably labelled and stored safely and securely. We can also perform further labeling and shipping activities for all clinical studies including randomised double-blind designs, and coordinate study re-supply to your requirements.

	On-site QC function undertakes a wide range of analytical assays
	The manufacturing site QC function handles environmental and services testing, a dedicated Analytical team develops, validates and conducts product and in-process testing.

	Experienced QA function
	Our GMP compliance status is dependent on the high standards of our QA function operating in partnership throughout the manufacturing facility.