Biotech Report Berlin-Brandenburg 2004/2005 - Biotechnologie.de

ADDRESS:
Biochrom AG
Leonorenstraße 2-6
D-12247 Berlin
CONTACT:
Phone +49 30 77 9906-0
Fax +49 30 771 00 12
info@biochrom.de
www.biochrom.de
BIOCHROM is a company dedicated to being a primary supplier of cell culture media
and quality animal sera. Established in 1981, the company manufactures and distributes
the full range of products related to mammalian cell culturing technique: standard
cell culture media, complete media tailored for particular cell types and cell lines, custom
formulations and animal sera, such as Fetal Bovine Serum (FBS). Serum products
are tested for sterility, adventitious viral agents, physico-chemical parameters, and biological
performance. BIOCHROM specializes in meeting customers‘ specifi cations and
regulatory concerns, to facilitate the manufacture of custom media, consistent with
Good Manufacturing Practice (GMP). The media are produced in a strictly controlled
environment; chemicals used conform, where applicable, to grade standards of European
Pharmacopoeia and US Pharmacopoeia. Cell culture as a platform technology,
and tissue engineering is becoming an important part in human health care. Through
numerous research projects with both universities and biotech companies, BIOCHROM
is connected to intellectual resources specializing in today’s cell culture applications.
Manufacturing standards
BIOCHROM offers highest quality and competitive pricing at the same time; all
manufac turing processes and strict quality systems enable and guarantee low endotoxin
levels for liquid bulk products. BIOCHROM follows Good Manufacturing Practice
(GMP) guidelines: this requires validation, and documentation of all operational procedures,
systems, functions, facilities, materials, and equipment. BIOCHROM has established
Standard Operating Procedures (SOPs) for all its anufacturing and quality procedures.
The company validates its equipment and processes on a regular level to ensure
that they meet specifi c designed criteria in adaptation to internal and external quality
assurance. Audits are performed to verify that manufacturing and quality control functions
are being properly executed.
Sterile Process Liquids, Buffers and Balanced Salts from BIOCHROM
Rapid advances in biopharmaceutical production have created a growing need for reliable
sources of sterile process liquids delivered ‘just in time’. BIOCHROM’s production
of bulk sterile liquids is based on its source of highly purifi ed water, that does meet the
Water for Injection (‘WFI’) criteria. All commonly used buffers, balanced salts and cell
culture media are available according to customer’s own specifi cations, manufactured
under GMP, and ISO 9001 guidelines. All BIOCHROM process liquids are intensively tested
prior to QC release, and packed in containers ranging from 100, 500 and 1000 ml PETbottles,
100 ml to 50 ltrs media bags or larger volumes of 200, 500 and 1000 ltrs media
bags, shipped out in appropriate stainless steel containers.
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