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.
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
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.
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.
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.
