About BioChem

Founded in the early 1970s, BioChem Labor für biologische und chemische Analytik GmbH is one of the leading GMP-certified analytical contract laboratories for the pharmaceutical, medical devices, diagnostics, cosmetics and chemical industries in German-speaking countries.

Our core competences are:

  • Microbiology
  • Analytics
  • Molecular biology/bioanalytics
BioChem laboratory building, Karlsruhe, Germany

Since 2022, in addition to the GMP certificate, BioChem also holds the manufacturer’s authorisation. The laboratory has been registered with the U.S. Food and Drug Administration (FDA) for many years and has been successfully inspected repeatedly.

At its Karlsruhe site, BioChem employs more than 110 highly qualified staff with many years of professional experience who are experienced in the application of pharmacopoeia-relevant and client-specific methods as well as in working with highly effective and/or toxic substances e.g. narcotics, cytostatic drugs, hormones, antibiotics and CMR substances (carcinogenic, mutagenic, reproductive toxicity).

BioChem’s range of services includes:

Quality control and pharmaceutical development:

  • Raw materials, excipients, intermediate or finished products of any dosage form
  • Method development, transfer and validation
  • Identity, content, purity, residues
  • Cleaning validation

Release and stability tests:

  • EU Re-analysis
  • Storage according to ICH guidelines

GMP/GLP-compliant documentation:

  • Test specifications, plans and reports
  • Registration and approval support

BioChem has a licence to handle narcotics and narcotic precursors as well as to operate a genetic engineering facility of safety levels 1 and 2 (project-related, on request). We notified the authorities of the handling of pathogenic organisms and epizootic disease germs.

In the highly modern, newly equipped laboratory rooms in Gerichshain (near Leipzig), opened in July 2023, the performance of time-critical microbial count determinations such as water tests, as well as the incubation and evaluation of samples from environmental monitoring are offered

The laboratory is independent, family-owned and belongs to the BioChem Group. It is composed of BioChem Holding, Karlsruhe, and four subsidiaries:
BioChem Labor für biologische und chemische Analytik GmbH, Karlsruhe, Germany, www.biochem.de
BioChem agrar Labor für biologische und chemische Analytik GmbH, Gerichshain, Germany, www.biochemagrar.de.
BioChem Agrar Polska Sp. z o.o., Urbanowice, Poland and
BioChem AGROLOGIA SLU, Sevilla, Spain, www.biochemagrologia.es

In addition to the laboratory services as full-service provider, our worldwide clients value our comprehensive consulting services on all relevant topics, regardless of which phase of the life cycle their products or projects are in.

We attach particular importance to a trusting, partnership-based and long-term cooperation in which we competently support our clients in solving their problems. Our clients can safely rely on our quality and flexibility and trust our reliability.

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Our history

2023: New opening of the GMP-certified microbiology laboratory in Gerichshain (near Leipzig), Germany
In the highly modern, newly equipped laboratory rooms, the performance of time-critical microbial count determinations such as water tests, as well as the incubation and evaluation of samples from environmental monitoring are offered

2022: Obtaining manufacturer’s authorisation 
for human and veterinary medicinal products and human investigational medicinal products: microbiological, chemical/physical and biological quality control for medicinal products, raw and starting materials, active pharmaceutical ingredients and packaging materials

2018: Acquisition of nadicom division
Acquisition of nadicom’s GMP division to strengthen and expand BioChem’s molecular biological laboratory, including takeover of personnel

since 2017: Modernisation of laboratory building
Extensive modernisation and expansion measures of the laboratory building Daimlerstraße 5b | D-76185 Karlsruhe

2014: Foundation of BioChem Holding
Spin-off of all administrative and commercial tasks of the BioChem Group into the
BioChem Holding Beteiligungs- und Management GmbH

1998: Change of shareholders
Take-over of the laboratory after the death of the founder by his daughter, Dr. Lysan Massmann

1987: New building Daimlerstraße
New construction and occupation of the present laboratory building
Daimlerstraße 5b | D-76185 Karlsruhe

1981: Change of type of company to GmbH
Change of type of company to today’s
BioChem Labor für biologische und chemische Analytik GmbH

1973: Foundation of BioChem
Founded by Dr. Walter Massmann (†1998),
Specialist in pharmacology, microbiology and in occupational medicine

Our value system

BioChem attaches particular importance to a trusting, cooperative and long-term partnership in which we competently support our clients in solving their problems. Our clients can safely rely on our quality, flexibility and our reliability.

BioChem’s value system consists of 5 areas:

  1. Our mutual behaviour is characterised by fairness.
  2. We strive for sustainability in the form of lasting business relationships, high quality awareness and consistent competence.
  3. We see ourselves as a constantly learning organisation committed to a continuous improvement process.
  4. We promote and support responsible behaviour and positive-constructive cooperation among all.
  5. We are committed to social responsibility towards employees, society and the environment.

Read more about how we understand and live our values below.

  1. Our mutual behaviour is characterised by fairness.
    Fairness means respect and appreciation as a basic attitude. This includes recognising the needs of others, promoting individuality and showing respect, transparency and openness in dealing with each other. Towards our environment, an appreciative and respectful use of resources is a central guiding principle.
  2. We strive for sustainability in the form of lasting business relationships, high quality awareness and consistent competence.
    In the spirit of trustful cooperation, we are committed to creating the conditions for long-term prospects for our staff with optimal working conditions and to promote their development. It is our responsibility towards our business partners to secure their long-term trust.
  3. We see ourselves as a constantly learning organisation committed to a continuous improvement process.
    Changes in the company, in the market or with clients require continuous further development and adaptation in order to improve quality and performance.
  4. We promote and support responsible behaviour and positive-constructive cooperation among all.
    Within a finely tuned framework, we create the conditions for independent work – for a culture of reliability and trust in which clarity, the ability to reach a consensus, the ability to criticise and reflect are lived.
  5. We are committed to social responsibility towards employees, society and the environment.
    As a successfully operating company, we see the long-term safeguarding of the future as the basis of our welfare concept. Acting in a socially responsible manner also means allowing employees, society and the environment to share in our success.

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