ABOUT Quality & Certifications

Biowest, 35 years of serving life sciences

Biowest is committed to the highest standards and guarantees quality, reproducibility, traceability and premium service. 

Our commitments

Biowest is committed to the highest standards and guarantees quality, reproducibility, traceability and premium service.

Biowest’s market success is founded on a combination of competitive prices and a wide range of geographical origins, along with scrupulous attention to accountability and traceability and a fully vertically integrated end-to-end service in which the entire sourcing, manufacturing, distribution and documentation process is owned in-house. Using specialized equipment, detailed SOPs and audits, Biowest ensures quality control at every stage and low intra-lot variation.

Our certifications

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°1069/2009

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

Download EDQM certified FBS

Download EDQM certified Calf Serum

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. 

Download ISO 9001
Download ISO 13485

Members of the International Serum industry Association are collectors, processors and users of animal serum and animal derived products. These products are used extensively in the growth of cells in culture for research and in the production of diagnostic kits, vaccines and biotherapeutic molecules.

The International Serum Industry Association was formed in June 2006 with a specific focus on the Serum Industry. Since that time the scope of the Association has broadened to include all animal derived products used in the multibillion dollar life science and biomedical sectors. The Association does not currently include food applications or human derived materials within its sphere of influence.

The ISIA’s missions :

Ethics :
ISIA shall establish, promote and assure compliance with uncompromised standards of excellence and ethics in the business practices of the global animal serum and animal derived products supply industry.

Safety and Safe Use :
Our primary focus will continue to be on safety and safe use of serum and animal derived products through proper origin traceability, and truth in labeling, and appropriate standardization and oversight.

Education :
We will work to educate stakeholders on the scientific foundation of the safe use of serum and animal derived products.