Avecia Biologics: Development Expertise. Manufacturing Excellence

View PDF

 

 

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

Leave a Reply