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Serving Life Sciences since 1973
All Biowest equipment, chemicals and raw materials are of the highest quality.
We are committed to the highest standards and guarantee quality, reproducibility, traceability and premium service.
Our success is built on competitive pricing, global sourcing, full traceability, and a fully integrated in-house service from sourcing to delivery.
Using specialized equipment, detailed SOPs and audits, we ensure quality control at every stage and low intra-lot variation.
Our Certifications
All documentation is available in both printed and digital formats. Use the dropdown below to find and access the documents you need.
French Ministry of Agriculture Registration
Biowest SAS France is registered by the French Ministry of Agriculture (Regulation EU n°1069/2009) under the agreement number FR 49.231.001 for the production of animal sera and plasma – Intermediate Products & Technical Plant.
Download regulation EU n°1069/2009EDQM certified FBS and Calf Serum
EDQM certified FBS and Calf Serum is your guarantee that the origin and the manufacturing process of the product have been certified by the European Directorate for the Quality of Medicines & HealthCare.
The EDQM protects and promotes public and animal health in Europe.
Its mission is to :
- Promote the basic human right of access good quality medicines and healthcare.
- Develop and preserve human and animal health by means of official manufacturing standards.
- Implement quality control of medicines to the signatory states of the Convention for the elaboration of a European Pharmacopoeia.
Biowest produces sterile fetal bovine serum and calf serum, filtered and packed in its own facilities, which conforms to the current version of the products monograph no 1483 of the EDQM’s Pharmacopoeia concerning the risk of transmitting animal spongiform encephalopathy’s agents.
Biowest uses EDQM certified countries for FBS importation including Argentina, Brazil, Chile, Colombia, France, United States of America, Mexico, Panama, Costa Rica, Denmark, Ireland, Italy, Spain, Uruguay and Paraguay. Biowest uses only an EDQM certified country for the collection of Calf serum : France
ISO 9001 – ISO 13485 Certification
Biowest’s French production facility is certified to ISO 9001: 2015 and ISO 13485: 2016 standards while products meet EC Regulations 1069/2009 health rules for animal by-products and derived products not intended for human consumption.
It also complies with EC Regulation 999/2001, under which all European animals are tested for BSE before the corresponding blood processing.
Human Serum Regulation
The product is intended for in vitro, laboratory use only. Do not use in therapy, for human or veterinary applications.
The handling and sale of human-derived products in Europe are requires authorization.
In France, this authorization is granted by the Ministry of Higher Education, Research, and Innovation after the submission of a detailed file. Biowest holds the following authorizations :
- Import and export activities for scientific purposes of organs, tissues, and cells derived from the human body and their derivatives, blood, its components, and derived products.
- Conservation and preparation activities of human body elements for their transfer for scientific use.
In order to be able to sell these products to its customers, Biowest must register its clients in its import/export file and submit this updated document to the authorities for validation. The validation process takes between 1 and 3 months.
The following information is essential for this registration : name, delivery address, phone number, and intended use of the products.
Biowest cannot be held responsible for misuse of its human products by end users.