July 1, 2008
Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, their clinical development programme.
Process Development and Scale Up
Avecia’s experience ensures that process development is applied appropriately dependent upon the development needs of customer products at different clinical stages.
Expression in E. coli and yeast, including Pichia pastoris and Saccharomyces cervisiae
Wide range of constructs and expression options including developing a customer’s existing system or creating one de-novo from our family of microbial therapeutic protein production systems, including our pAVEway™ system
Purpose-built fermentation and cell culture development areas up to 100 L scale
100-L scale pre-cGMP pilot plant for process demonstration and supply of preclinical material
Full range of analytical methods available for in-process and final product analysis
Development of stable product formulations
Process development services for mammalian cell culture
cGMP Manufacturing
Four cGMP streams for the manufacture of microbially-derived biologics provide capacity from 100 L to 5,000 L:
cGMP cell banking facility for production of cGMP Master and Working Cell Banks
ABC1000: 100 L and 1,000 L fermentation scale cGMP pilot plant for rapid manufacture of phase 1-3 clinical product
ABC5000: 2 × 5,000 L manufacturing streams for large-scale and phase 3, process validation and commercial supply
Flexible plant configurations including disposables technology and refold volumes of 10,000 L
Full range of stability testing capabilities for drug substance and drug product
Quality and Regulatory Support
Independent Quality Unit with representation on programme teams:
MHRA inspected cGMP facilities
Compliance with Orange Guide Annex 18 and USA cGMP regulations
Regulatory support for IND/CTA Submission, DMF, and CMC as required
QC analysis and release of raw materials, environmental and water, in-process/final, retained samples
Ownership and use of qualified or validated methods
QualityAgreement/interactions with customers
Programme Management
Avecia brings a distinctive management approach to programmes:
Each programme is supported by a dedicated, multidisciplinary team led by a focused programme manager
Close customer interaction is promoted through regular teleconferences and face-to-face meetings
Programmes are milestone structured to ensure timely delivery
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