Salute

CMC Biologics Expands European GMP Manufacturing Capacity

- -- Bioreactor 6Pack™ facility design provides innovative, flexible solutions to customers for phase III and commercial production

SEATTLE and BERKELEY, California and COPENHAGEN, Denmark, May 20, 2015 /PRNewswire/ -- CMC Biologics, Inc., a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that as part of its global manufacturing capacity expansion strategy, it will add approximately 14,000 liters of additional manufacturing capacity to its Copenhagen, Denmark facility.

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Customers will soon have greater flexibility in the manufacture of large-scale, late-stage and commercial products through CMC Biologics' innovative single-use Bioreactor 6PackTM facility design. The Bioreactor 6Pack™ configuration consists of six 2000L production bioreactors in one manufacturing line, allowing for flexible production with scales from 2,000L to 14,000L in a single production suite. The bioreactors can be run singly or in groups, simultaneously, sequentially or in staggered fashion to achieve production needs.

The Copenhagen installation, scheduled for initial GMP production in November 2015, will consist of a Bioreactor 3Pack™ configuration consisting of a seed train and three 2,000L single-use production bioreactors. Three additional 2,000L bioreactors will be added at a later date to complete the Bioreactor 6Pack™ line. We have completed construction of the Bioreactor 6Pack™ in the Seattle facility and will conduct the first GMP run mid-2015, and will be in full production for a commercial launch later this year.

"CMC Biologics is significantly investing in innovative facility design to address our customers' need for production flexibility, to meet aggressive regulatory and production timelines and to speed their products to market," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "We are changing the way CMOs operate and our novel Bioreactor 6PackTM facility design is one more step in leading the market in technical excellence."

About CMC Biologics CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes.

More detailed information can be found at www.cmcbiologics.com.

20 maggio 2015 ADNKronos
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