SynCo Bio Partners B.V. is a
biopharmaceutical good manufacturing practices (GMP)
contract manufacturing organization
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organ ...
(CMO) located in Amsterdam, the Netherlands, licensed for clinical and commercial GMP manufacturing of bulk drug substances and drug products. SynCo offers a fully integrated range of biopharmaceutical development and manufacturing services supporting small biotech to large pharmaceutical organizations worldwide from the earliest stages in process development, through preclinical and clinical trials, approval and market supply.
SynCo’s multi-purpose GMP facilities offer manufacturing capabilities for
microbial
A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
- and
mammalian
Mammals () are a group of vertebrate animals constituting the class (biology), class Mammalia (), characterized by the presence of mammary glands which in Female#Mammalian female, females produce milk for feeding (nursing) their young, a ...
-based biopharmaceuticals for worldwide supply. It is one of approximately ten biopharmaceutical CMOs in the world with both clinical and commercial manufacturing experience.
SynCo is a fully owned subsidiary of Wacker Biotech GmbH (a subsidiary of
Wacker Chemie AG
Wacker Chemie AG is a German multinational chemical company which was founded in 1914 by Alexander Wacker. The company is controlled by the Wacker family holding more than 50 percent of the shares. The corporation is operating more than 25 prod ...
).
History
*1988 -
Cetus Corporation
Cetus Corporation was one of the first biotechnology companies. It was established in Berkeley, California, in 1971, but conducted most of its operations in nearby Emeryville. Before merging with Chiron Corporation in 1991 (now a part of Novarti ...
, Emeryville, CA, US establishes its European headquarters, EuroCetus B.V. in Amsterdam, the Netherlands.
*1990-1991 - EuroCetus facility licensed for production and release of
ProLeukin (IL-2) for Europe and rest of world, except US and Japan.
*1992 –
Chiron Corporation acquires Cetus Corporation. Eurocetus B.V. becomes Chiron B.V.
*1996 – Facility licensed for commercial production of
Pertussis vaccine.
*1997 – Facility licensed by WHO for commercial production of
Meningitis A polysaccharides.
*1997-1999 – Facility licensed by UK, MCA and Italian Health Branch for Meningitis C polysaccharide and CRM197 carrier protein for conjugated vaccine Menjugate.
*2000 – Facility acquired by Dr William J. Rutter. SynCo Bio Partners B.V. established.
*2001 – Facility licensed by
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
and
Health Canada
Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...
for Meningitis C polysaccharides and CRM197
carrier protein for Menjugate production.
*2004 – Installation of new air handling systems completed for all of its facilities.
*2005 – Installation of new aseptic filling machine in its Class A zone, allowing larger batches sizes and expansion of filling ranges.
*2005 – Expansion of GMP facilities to allow production of a wider range of protein, vaccine and live biotherapeutic products.
*2006 – Facility licensed by
Korean FDA for commercial production.
*2008 – Expansion of process development capabilities to enable a greater range of projects to be completed.
*2009 – Facility licensed by
Anvisa
Brazilian Health Regulatory Agency ( pt, Agência Nacional de Vigilância Sanitária, links=no, italics=yes, ''Anvisa'', literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during Presi ...
for commercial production.
*2011 – Expansion of the Class A zone of its aseptic filling facility successfully completed, allowing SynCo to support new product launches in the US and the rest of the world.
*2016 – Facility licensed by
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
for commercial production of VaxChora.
*2018 – SynCo Bio Partners B.V. acquired by Wacker Chemie AG and has become part of Wacker Biotech GmbH.
References
www.syncobiopartners.com
External links
{{Official website, http://www.syncobiopartners.com
Manufacturing companies based in Amsterdam
Dutch brands
Pharmaceutical companies of the Netherlands
Vaccine producers