BioChem

What BioChem does

BioChem Labor für biologische und chemische Analytik GmbH is a family-owned, GMP-certified contract laboratory headquartered in Karlsruhe, Germany, with a second GMP-certified microbiology site in Gerichshain near Leipzig opened in July 2023. Founded in 1971 by Dr. Walter Massmann and now controlled by the Massmann family through BioChem Holding Beteiligungs- und Management GmbH, the company employs over 140 highly qualified staff and serves worldwide clients across the pharmaceutical, medical device, diagnostics, cosmetics, and chemical industries. BioChem holds Manufacturer's Authorisation for human and veterinary medicinal products (since 2022), GMP and GLP certifications, and FDA registration under FEI 3004058183 with a track record of successful inspections.

The company operates three core analytical departments: Microbiology, Physico-chemical Analytics, and Bioanalytics. Capabilities span microbiological testing (sterility, endotoxin via LAL/rFC, Monocyte Activation Test, environmental monitoring), chromatographic and spectroscopic analyses (HPLC/UHPLC, GC, ICP-MS, FT-IR, AAS, capillary electrophoresis), and bioanalytical/molecular biology methods for biological contamination, mycoplasma, cell-based assays, and increasingly characterisation of monoclonal antibodies and large molecules. It also operates an LIMS/GxP IT infrastructure, ICH-conditioned stability storage, and a partner laboratory network for highly specialised techniques beyond its core portfolio.

BioChem generates revenue on a project-based transaction-fee model with individual quotes per client specification, supplemented by Qualified Person (QP) services, stability study programmes, and a regional sample transport service within ~300 km of Karlsruhe. Go-to-market is sales-led with direct enterprise engagement, supplemented by participation in trade shows (CPHI Frankfurt 2025, PharmaLab 2025 Düsseldorf, LOUNGES Cleanroom Processes 2026), LinkedIn presence, technical publications in pharmind, and downloadable company collateral. Recent strategic moves include a 2026 expansion of the Bioanalytics department targeting the biopharmaceutical industry, a December 2025 launch of the animal-free MAT pyrogen test aligned with the EU ban on the Rabbit Pyrogen Test, and the 2023 Gerichshain site opening to add capacity for time-critical microbiology.

Name

BioChem

Legal name

BioChem Labor für biologische und chemische Analytik GmbH

Website

https://biochem.de

Company type

Private

Founded year

1971

Operating status

Operating

Headcount range

51–100 employees

Short description

BioChem is a family-owned, GMP-certified German contract laboratory in Karlsruhe with a second site in Gerichshain, providing microbiological, physico-chemical, and bioanalytical testing services to pharmaceutical, medical device, diagnostics, cosmetics, and chemical industry clients worldwide.

Ownership category

akta.pro rank

Product category

Contract Analytical Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAGAF

Analytical Development & QC Testing (Release/Stability/Potency)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Biopharma Manufacturing Services (Biologics/Cell & Gene)

SECONDARYHLAGADAE

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Testing & Analytical Services

SECONDARYHLAGAGAL

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Biopharma Manufacturing Services (Biologics/Cell & Gene)

SECONDARYHLAGADAH

Cell-Based & Potency Assays (Bioassays)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Testing & Analytical Services

Keywords

• Contract analytical services
• Pharmaceutical quality control
• Microbiological testing
• GMP certified laboratory
• Bioanalytical services

Headquarters

HQ city

Karlsruhe

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. Contract Analytical Services: Project-based contract analysis services for pharmaceutical, medical device, diagnostics, cosmetics, and chemical industries. Services span entire product lifecycle from pharmaceutical development through routine quality control. Pricing provided via individual offers based on client specifications, test parameters, and volume.
2. QP Services: Qualified Person (QP) services including confirmation of quality control by QP, storage of retention samples per § 18 AMWHV, consulting on obtaining manufacturer's authorisation, and GMP/regulatory consulting.
3. Stability Studies: Stability study services including storage (climate-controlled rooms) and analytical testing per ICH guidelines. Expenses determined by test material specifications, quantities, and study protocols.
4. Transport Service: Sample transport service within ~300 km radius of Karlsruhe under qualified conditions (e.g., 2–8°C) for reliable and cost-effective shipping.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

BioChem is a GMP-certified independent contract analytical laboratory providing full-service quality control testing in three departments: Microbiology, Physico-chemical Analytics, and Bioanalytics. The company serves pharmaceutical, medical device, diagnostics, cosmetics, and chemical industry clients with method development and validation, release and stability testing, QP services, and regulatory consulting. The laboratory holds manufacturer's authorisation for human and veterinary medicinal products, is FDA registered, and operates a second microbiology facility in Gerichshain.

Product overview

BioChem is a GMP-certified independent quality control laboratory offering a broad portfolio of laboratory and consulting services in three core areas: Microbiology, Physico-chemical Analytics, and Bioanalytics. Their services encompass contract testing for pharmaceuticals, medical devices, diagnostics, cosmetics, and chemical industries. The service offering is structured as a unified full-service model where clients receive comprehensive analytical testing, method development and validation, stability studies, and regulatory consulting (QP Service) from a single provider. Key offerings include microbiological testing (sterility, endotoxins, hygiene monitoring), physico-chemical analyses (chromatography, spectroscopy), bioanalytical testing (biological contamination detection, cell-based assays), and specialized services such as the Monocyte Activation Test (MAT) as an animal-free pyrogen testing alternative, stability storage, and sample transport.

Differentiator

Problem solved

Functional benefit

Products and services

• Microbiology Services Comprehensive microbiological testing services including examination of non-sterile products, sterility testing, endotoxin testing (LAL test and rFC test), identification of microorganisms via morphological, mass spectrometric (MALDI TOF), and molecular biological methods, antimicrobial preservation efficacy testing, and microbiological hygiene monitoring. Serves pharmaceutical, medical device, cosmetics, and chemical industry clients in GMP-regulated environments.
• Physico-chemical Analytics Wide range of physico-chemical analytical testing services including chromatography (TLC, HPLC/UHPLC, IC, GC), spectroscopy (UV/VIS, FT-IR, AAS, ICP-MS), electrochemical analyses, physical property testing, particle testing, method development and validation, stability studies, and pharmaceutical water testing. Serves pharmaceutical, medical device, diagnostics, cosmetics, and chemical industry clients.
• Bioanalytics Bioanalytical testing services including detection of biological contaminations (DNA, RNase, ATP, bacterial endotoxins via rFC test, mycoplasma), content and identity determination via fluorometric and photometric methods, capillary electrophoresis, amino acid analyses, molecular biological identification of microorganisms, and cell-based assays. Strategic 2026 expansion adds CE-SDS, cIEF, IEC, SEC, and CE techniques for monoclonal antibody and large-molecule characterization.
• QP Service (Qualified Person Services) Qualified Person (QP) services including confirmation of quality control, storage of retention samples per §18 AMWHV, consulting on obtaining manufacturer authorization, and additional GMP and regulatory consulting services. For pharmaceutical manufacturers needing QP oversight and regulatory guidance.
• Stability Studies (Storage and Analyses) Stability storage and analysis services for pharmaceutical products including stress and photostability testing, short- and long-term stability studies using computer-monitored climate rooms storing samples at ICH conditions (-20°C to 40°C/75% r.h.). Includes narcotics storage capability. Pricing determined by test material specifications, quantities, and study protocols.
• Monocyte Activation Test (MAT) Animal-free in vitro pyrogen test per Ph. Eur. 2.6.30 that detects both endotoxin and non-endotoxin pyrogens (NEPs) by simulating human immune response through monocyte activation. Launched December 2025 as an alternative to the Rabbit Pyrogen Test (RPT) banned in Europe from July 2025.
• Sample Transport Service Transport service for reliable and cost-effective shipping of samples within approximately 300 km of Karlsruhe under qualified conditions (e.g., 2-8°C). Arranged through the headquarters contact.

Quantifiable outcome

• Successfully completed multiple FDA inspections and maintained FDA registration under FEI 3004058183
• +2 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators6 records

Recent moves12 records

Expansion highlights6 records

Direct peers

• GBA Group: Hamburg-based independent analytical laboratory group serving the pharmaceutical, food, environmental, and life science sectors with GMP/GLP testing. Closest German-headquartered peer to BioChem in scale, service portfolio, and pharma QC focus.
• Labor LS SE & Co. KG: German contract analytical laboratory providing GMP-compliant pharmaceutical quality control, microbiological testing, and stability studies. Direct head-to-head competitor in the German pharma QC contract lab market.
• PHAST GmbH: German pharmaceutical contract laboratory specializing in GMP-compliant analytics, release testing, and method development. Highly comparable to BioChem in target customers (pharma manufacturers) and service mix.
• Nelson Laboratories (Sotera Health): US/Europe-based contract laboratory specializing in microbiological and analytical testing for medical devices and pharmaceuticals. Comparable in GMP microbiology, sterility, and endotoxin testing to BioChem's core offering.

Broad incumbents

• Eurofins Scientific: Global leader in contract laboratory testing including pharmaceutical, biopharma, and microbiological services. Provides a broad incumbent benchmark for scale, regulatory reach, and pricing pressure on mid-sized European pharma labs.
• SGS SA: Global testing, inspection, and certification company with a large life sciences / pharma contract services division. Competes with BioChem for international pharma QC work and stability programs.
• Intertek Group: Global quality-assurance provider with pharmaceutical services spanning analytical testing, release, and stability. Overlaps with BioChem on multinational pharma client programs.
• Charles River Laboratories: Major biopharma contract research organization with extensive analytical, microbiological, and biologics safety testing. Represents the scaled global competitor BioChem is positioning its Bioanalytics 2026 expansion against.
• WuXi AppTec: Global CRO/CDMO with large-scale biologics analytical testing capabilities for mAbs and large molecules. Defines the global capacity benchmark for the biopharma testing category BioChem is entering.

Regional players

• Mikrobiologisches Labor Dr. Michael Lohmeyer: Specialized German contract microbiology laboratory serving pharmaceutical and medical device manufacturers. Regionally comparable niche player in GMP microbiology, though narrower in scope than BioChem.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/biochem
• Xx.com/biocheminka

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BioChem