Avecia Biologics: Development Expertise. Manufacturing Excellence
July 1, 2009
Adedicated contract manufacturing organization supporting the biotechnology and pharmaceutical industries from preclinical process invention to postlaunch, commercial scale manufacture.
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, its clinical development program.
Process Development and Scale Up
Avecia’s experience ensures 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 cerevisiae
Wide range of constructs and expression options including development of 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
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 program teams
FDA and 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
Quality Agreement/interactions with customer
Program Management
Avecia brings a distinctive management approach to programs:
Each program is supported by a dedicated multidisciplinary team led by a focused program manager
Close customer interaction is promoted through regular teleconferences and face-to-face meetings
Programs are milestone structured to ensure timely delivery
Mammalian Cell Culture
In addition we are also able to help customers working with mammalian cell culture derived biologics, with essential process development and preclinical manufacturing services:
Vector construction and rapid cell line selection/amplification
Cell culture process creation and development
Downstream process development including viral clearance and resin recycle studies
Assay development and validation
Scale up studies
Technology transfer options for CGMP at customer or partner facilities
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