Aseptic inNOVAtion from lab to launch
Nova designs and constructs its own isolator equipment and has developed an expertise in the application of gassed isolator technology for aseptic manufacturing processes. With our unique in-house engineering services, we have successfully incorporated many complex processes into them, including the world’ s first cGMP spray drying process approved by both the EMA and FDA.
In partnership with our clients Nova has utilised this technology for a wide range of novel applications, including the commercial aseptic manufacture of antibiotic bone cements, contract filling and assembly of aseptically prepared products for development and clinical trials, aseptically spray dried products and ATMPs.
Nova has a purpose built live biologics facility, dedicated to the manufacture of CAR-T cell and gene therapies( viral vectors) for clinical and commercial use. This facility has been operational for 15 years and offers unparalleled levels of sterility assurance. Nova has collaborated closely with OXB for over 12 years supporting the development, clinical and commercial manufacture of lentiviral vector ATMPs, leading to the approval of the worlds first CAR T-cell therapy.
Thanks to our technical excellence and specialised experience we have a global reputation for complex aseptic processing of pharmaceutical, biopharmaceutical and medical device products when terminal sterilisation is not an option. Capable of routine liquid fill / finish from small hand filled batches to automated batches of up to 20,000 vials, we are your trusted partner for any clinical trial work from pre-clinical testing through to large Phase III trials and commercial supply of high value niche products. We also provide a“ turnkey” solution with in-house analytical and microbiological testing, clinical trial labelling and packaging, and QP release.
Our extensive experience in filling a wide range of products, either formulated in-house or preformulated, includes:
• Small molecules
• Peptides
• Proteins
• Monoclonal and polyclonal antibodies
• Immunoconjugates
• DNA plasmids
• Live biologicals BSL1 and 2 Viral vectors
Find out more
Visit our website www. novalabs. co. uk
+ 44( 0) 116 223 0100 info @ novalabs. co. uk
Nova Laboratories Ltd, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL