BioChem
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.
- Company typePrivate
- Founded1971
- HeadquartersKarlsruhe, Germany
- Headcount51–100
- GTM typeB2B
- OfferingServices
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.
BioChem firmographics
Firmographics- 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
BioChem industry classification
Industry- 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 primary industry
- Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF)
- akta.pro secondary industries
- Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL), Cell-Based & Potency Assays (Bioassays) (HLAGADAH)
Keywords
Where BioChem is headquartered
LocationHeadquarters
- HQ city
- Karlsruhe
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
BioChem business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- 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.
- 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.
- 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.
- 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
BioChem product offering
Product offeringCore 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
Companies that use BioChem
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles4 records
BioChem technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
BioChem partnerships and signals
Strategic signalScale indicators6 records
Recent moves12 records
Expansion highlights6 records
BioChem competitors and assessment
Company assessmentDirect 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
BioChem social profiles
Digital presenceBioChem compliance and trust
Trust signalCompliance9 records
BioChem financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioChem leadership team
Management profileNumber of profiles
Profiles15 records
BioChem subsidiaries and ownership
Company hierarchySubsidiaries3 records
BioChem funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioChem M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioChem
What does BioChem do?
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.
Is BioChem a public or private company?
BioChem is a private company. It is classified as family owned and is currently operating.
When was BioChem founded?
BioChem was founded in 1971. It employs 51 to 100 people.
Where is BioChem based?
BioChem is headquartered in Karlsruhe, Germany, in the Europe region.
How does BioChem make money?
Four revenue lines are on record. Contract Analytical Services are the primary driver. The others are QP Services, stability Studies and transport Service.
Who are BioChem's main competitors?
Direct peers on record are GBA Group, Labor LS SE & Co. KG, PHAST GmbH and Nelson Laboratories (Sotera Health). Broad incumbents are Eurofins Scientific, SGS SA, Intertek Group, Charles River Laboratories and WuXi AppTec. Mikrobiologisches Labor Dr. Michael Lohmeyer is listed as a regional player.
Does BioChem have an API?
No public API is recorded for BioChem.
What industry is BioChem in?
BioChem's product category is Contract Analytical Laboratory Services. Its primary akta.pro industry code is HLAGAGAF, Analytical Development & QC Testing (Release/Stability/Potency), with a secondary code of HLAGADAE, Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility). Its NAICS code is 621511 and its SIC code is 8734.