Facility and Capacities

GMP Facility Organization

Biomay operates a plant of 400 m2 which comprises the GMP core facility, nonGMP laboratories and offices. The GMP facility consists of following areas:

  • Clean room class D (fermentation, homogenization, refolding, primary recovery)
  • Clean room class C (downstream processing, ultra/diafiltration)
  • Clean room class A/B (unidirectional airflow units for aseptic filling/finishing)
  • Air locks for personnel and material flow
  • State-of-the-art heat ventilation and air conditioning system (HVAC)
  • Preparation, service and storage areas
  • Quality control laboratories

Personnel air locksClass A laminar hoods

Processing Equipment and Techniques

The complete process chain is established for processing of microbial-derived biopharmaceuticals. Production equipment is generally fully qualified (IQ/OQ/PQ) and procedures for equipment cleaning and cleaning validation are established. Whenever necessary or useful, Biomay includes disposable (single-use) materials into its manufacturing processes.

The following equipment and technologies are available:

Robust and reliable bioprocess engineering

Fermentation

  • Rotary shakers
  • Bioreactor 20 L
  • Batch or fed-batch cultivation mode
  • High cell density cultivation


Cell Separation and Homogenization

  • Continuous flow centrifuges
  • High pressure homogenizer
  • Alkaline or enzymatic cell lysis


Primary Recovery (Pre-Purification)

  • Precipitation techniques
  • Inclusion body processing / refolding


Chromatography

  • Ion exchange (CEC, AEC)
  • Hydrophobic interaction (HIC)
  • Size exclusion (SEC)
  • Immobilized metal affinity (IMAC)
  • Affinity (AC)


Filtration

  • Depth filtration
  • Ultra/diafiltration
  • 0.2 µm filtration

Fill and Finish (Clean Room Class A)

  • Aseptic filling of drug substance (API)
  • Lyophilization

NEWS

Meet Biomay at BIO International Convention in Chicago (May 3 – 6, 2010)

Biomay will promote its third party cGMP contract manufacturing business at BIO2010. In addition Read more >>

Boehringer Ingelheim RCV and Biomay Cooperate in GMP Manufacturing of Plasmid DNA (February 1, 2010)

Boehringer Ingelheim RCV GmbH & Co KG, one of the global leaders in the production of biopha Read more >>

New Aliquot Sizes and Prices of Research-grade Recombinant Allergens (Jan 20, 2010)

Biomay wishes to inform its customers about a few changes in the distribution of its research-gr Read more >>