Diosynth Biotechnology, based in Research Triangle Park, NC (USA) and MSD Biologics (formerly Avecia Biologics) based in Billingham, UK have combined to form the BioManufacturing Network. Together the two organizations offer industry-leading CGMP contract manufacturing services for recombinant proteins, vaccines, and monoclonal antibodies with an attractive geographical footprint in the USA and Europe. Our combined expertise enables our customers to improve the cost-effectiveness of new therapies by providing fast-track progress into and through their clinical development program, process validation, commercialization, and supply.

Proven Track Record

Our track record in delivering successful programs will provide manufacturing support as your product reaches its next clinical stage quickly, economically, and on time. Our experience includes:

• Development and manufacturing of more than 140 proteins
• Extensive clinical and commercial CGMP manufacturing experience, including four commercial products
• Expression in Escherichia coli, yeasts (including Pichia pastoris and Saccharomyces cerevisiae), CHO, baculovirus (BEVS), NS0, and SP2/0
• Development, scale-up, and validation of PEGylation unit operations — including site specific PEGylation chemistry as well as linear and branched forms of PEG
• World-class technical services and R&D teams on both sites for seamless technical transfer and scale-up to CGMP manufacturing
• A track record of on-time delivery through experienced and distinctive program management teams
• Routine commercial supply of drug substance to support regulatory approvals in multiple markets.

Process Development and Scale-Up

Our experience ensures process development is applied appropriately, dependent upon the development needs of customer products at different clinical stages:

• 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 and mammalian therapeutic protein production systems, including our award-winning pAVEwayâ„¢ system
• Microbial capability in the development laboratories include multiple 5-L, 15-L, and 140-L fermentors
• Mammalian capability in the development laboratories include multiple 2-L, 5-L, 10-L, 15-L, 20-L, and 110-L bioreactors, Wave 20/50, and 200-L Xcellerex single-use systems
• ~100-L scale pre-CGMP pilot plant for process demonstration and supply of pre-clinical material.

CGMP Manufacturing

At our sites in Research Triangle Park, NC and Billingham, UK, we offer fully flexible clinical and commercial CGMP facilities for both microbial and mammalian cell culture production. We employ protocol-driven technology transfer processes to bring in projects from customers and seamlessly integrate them into these facilities. We are currently licensed to manufacture four commercial products with additional products pending approval.

Microbial Fermentation: Various scales for rapid CGMP manufacture of material for phase 1–3 clinical supply, process validation and commercial supply (1 × 100 L; 1 × 140 L, 1 ×1,000 L; 1 × 2,000 L; 2 × 2,000 L; 2 × 5,000 L) with flexible plant configurations including disposables technology and refold volumes of up to 10,000 L.

Cell Culture: 2 × 110 L and 1 × 2,000 L train (20, 145, and 650 L) for CGMP manufacture of material for phase 1–3 clinical supply, process validation, and commercial supply.

Manufacturing Support Services: The following additional services are offered to reduce complexity and risk of multiple suppliers:

• CGMP cell banking facilities for production of master and working cell banks
• Buffer screening studies to support downstream process development
• Development of stable product formulations
• Generation and characterization of reference material
• Full range of in-house analytical methods available for in-process and drug substance and drug product analysis
• Full range of stability testing capabilities for drug substance and drug product.

Quality and Regulatory Support

As you would expect of a world-class CMO, we provide all the necessary quality and regulatory support through an independent quality unit to ensure your product meets international regulatory requirements. Our combined regulatory inspection history includes FDA (CBER and CDER), MHRA, EMEA, Health Canada, ANVISA, and certification by JMHLW:

• Regulatory support for IND/CTA submission, DMF, and CMC as required
• QC analysis and release of raw materials, environmental and water in-process/final, with sample retention
• Ownership and use of qualified or validated methods
• Quality agreement followed by routine interactions with customer throughout the program.

Program Management

Our distinctive approach to program management ensures open communications and performance of programs on time and on budget, thereby ensuring we deliver to your expectations:

• Each program is supported by a dedicated, multidisciplinary team led by an experienced and focused program manager
• Close customer interaction is promoted through regular teleconferences and face-to-face meetings
• Programs are milestone structured to ensure timely delivery.

BioManufacturing Network is a part of Merck. Merck is known as MSD outside the United States and Canada.

Author Details
Bridget Hall is communications manager for MSD Biologics in Billingham, UK, and Anitra B. Johnson is a marketing specialist for Diosynth Biotechnology, 101 J. Morris Commons Lane, Morrisville, NC 27560; anitra.johnson@merck.com, https://merck.com/bmn.