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