Biochrom
The company
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). All sera are prescreened prior to acceptance; only those
lots that meet strictly quality control requirements are accepted for further
processing and subsequent sale to customers. Serum products are tested for
sterility, adventitious viral agents, physico-chemical parameters, and
biological performance.
The manufacturing processes are designed for the specific needs of customers
engaged in biotechnological research, developement and biopharmaceutical
production.
BIOCHROM specializes in meeting customers‘ specifications 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. As part of this exciting development,
BIOCHROM puts growing research efforts in the developement of media suitable for
applications such as somatic cell therapy, tissue replacement and organ
transplantation, manufactured according to GMP standards.
Through in-licensing and 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 manufacturing 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.
Products are prepared by an aseptic process for which each step has been
validated to ensure that all liquids do meet the highest standards.
BIOCHROM has established Standard Operating Procedures (SOPs) for all its
manufacturing and quality procedures. The company validates its equipment and
processes on a regular level to ensure that they meet specific 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
purified 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 specifications, manufactured under GMP, and ISO 9001
guidelines. Production incorporate a rigorous specification and approval process
that includes screening of all incoming related raw material, this specifies
Ph.Eur. grade components, and/or components of non-animal origin.
All BIOCHROM process liquids are intensively tested prior to QC release, and
packed in containers ranging from 100, 500 and 1000 ml PET-bottles, 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.
Product Navigation
Antibiotics Antisera, Antibodies Balanced Salts and Buffers Cell Attachment Factors Cell Culture Diagnostics Cell Culture Media Cell Culture Reagents Complete Culture Media Other Separating Solutions and Lectins Sera Tissue Desintegration Enzymes
|