BIBITEC GmbH & Co. KG

What BIBITEC GmbH & Co. KG does

BIBITEC GmbH & Co. KG is a Bielefeld-based Contract Manufacturing Organization (CMO) that produces biological active pharmaceutical ingredients (APIs) under GMP using mammalian cell culture, primarily for pharmaceutical and biotechnology clients developing monoclonal antibodies, antibody fragments, enzymes, hormones, and recombinant proteins for clinical trials Phase I through III. The company was founded in 2001 as a spin-off of the Institute of Cell Culture Technology at the University of Bielefeld and has accumulated more than 20 years of process development and GMP manufacturing experience, including the production of the entire Phase III material for EPO-Zeta (Retacrit, Silapo), the second erythropoietin biosimilar approved by the European Commission.

The technical offering is structured as an integrated service portfolio covering upstream processing (batch, fed-batch, and perfusion cell culture; serum-free adaptation; Master and Working Cell Bank production), downstream processing (platform purification for mAbs and individualized purification for enzymes and glycosylated proteins; virus removal validation; scale-up from 1 mL to >200 L), comprehensive quality control analytics (CEDEX, RP/SEC-HPLC, HCP ELISA, residual CHO DNA qPCR, virus and stability studies), and full regulatory support from preclinical through worldwide registration. Pilot-scale production capacity extends to 200 L in-house, with scale-up to 2,000 L available through a partnership with sister company Nordmark Biotech, enabling end-to-end coverage from process development to market supply.

BIBITEC generates revenue through project-based, multi-year contract manufacturing engagements priced per project against scope, scale, and regulatory requirements. The company operates exclusively via direct B2B enterprise sales and is a wholly-owned subsidiary of Nordmark Pharma GmbH within the Nordmark group. Customer segments are primarily pharmaceutical and biotechnology companies, with academic and research institutions serving as a secondary segment. In August 2024 the company relocated to a new GMP-compliant facility on Gütersloher Straße in Bielefeld, reinforcing its positioning as a specialist, regulatory-licensed CMO for mammalian-cell-derived biologics.

Name

BIBITEC GmbH & Co. KG

Legal name

BIBITEC GmbH & Co. KG

Website

https://bibitec.de

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

BIBITEC is a Bielefeld, Germany-based Contract Manufacturing Organization providing GMP-compliant mammalian cell-culture protein production for pharmaceutical and biotechnology clients, spanning process development, purification, analytics, and regulatory support for clinical trials up to Phase III.

Ownership category

akta.pro rank

Headquarters

HQ city

Bielefeld

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services (CMO): BIBITEC operates as a Contract Manufacturing Organization providing GMP-compliant protein production services using mammalian cells. Revenue is generated through project-based contracts for drug substance manufacturing for clinical trials up to Phase III. Services include upstream processing, downstream purification, quality control, and regulatory support as integrated packages.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

BIBITEC is a Contract Manufacturing Organization (CMO) providing GMP-compliant active pharmaceutical ingredient (API) production using mammalian cell cultures for clinical trials up to Phase III. Its service portfolio covers four integrated pillars: cell culture (upstream processing), protein purification (downstream processing), quality control analytics, and regulatory consulting and registration support, delivered with a one-stop-shop approach through its parent Nordmark Pharma GmbH covering the entire value chain from process development to market supply.

Product overview

BIBITEC GmbH & Co. KG is a Contract Manufacturing Organization (CMO) providing comprehensive services for GMP-compliant protein production using mammalian cells. The company's offering is organized as an integrated service portfolio rather than a software platform. The core offering is GMP Protein Production, which encompasses the entire value chain from cell culture (Cultivation Services) through purification (Purification Services), quality analytics (Quality Control Services), and regulatory support (Regulatory Services). Production capacities span from lab scale (2 L) for development through pilot scale (200 L) for clinical trials to production scale (2,000 L) for market supply in partnership with Nordmark Biotech. The company specializes in monoclonal antibodies, antibody fragments, enzymes, hormones, and other recombinant proteins.

Differentiator

Problem solved

Functional benefit

Products and services

• GMP Protein Production Full-service GMP-compliant active pharmaceutical ingredient (API) production using mammalian cell cultures for clinical trials up to Phase III, specialising in non-recombinant proteins, monoclonal antibodies, antibody fragments, and recombinant proteins; production scales from lab (2 L) through pilot (200 L) up to 2,000 L via Nordmark Biotech partnership.
• Cultivation Services (Upstream Processing)

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and secondary.

• Nordmark Pharma GmbHcoreOthers100% parent company of BIBITEC. Provides centralized point of contact for all project needs. Together with Nordmark Biotech, covers entire value chain from process development to market supply. Production scale up to 2,000 L available through this partnership.
• Trenzyme GmbHsecondaryStrategic or Co-development PartnerGerman Contract Research Organization (CRO) offering cell line development and recombinant protein production services. Partner since 2000, serving clients from academia to large pharmaceutical companies.
• Biofidus AGsecondaryStrategic or Co-development PartnerBioanalytical company located in Bielefeld, Germany. Provides bioanalytical methods including spectroscopic, chromatographic, and mass spectrometric assays for protein and small molecule characterization.
• BAG Health Care GmbHsecondaryStrategic or Co-development PartnerPharmaceutical contract manufacturer specializing in aseptic filling and lyophilisation of parenteralia. Offers small to mid-size batch manufacturing for market supply or clinical trials, including analytical services, packaging, serialization, and drug product release.
• Norbitec GmbHsecondaryStrategic or Co-development PartnerJoint venture founded by BIBITEC with BIOCEUTICALS and NORDMARK for market supply of EPO-zeta. Located on Nordmark campus. Prof. Lütkemeyer headed the joint venture for the first four years.

Scale indicators5 records

Recent moves10 records

Expansion highlights4 records

Emerging players

• Trenzyme GmbH: Smaller German CRO/CDMO offering cell line development and recombinant protein production services; a comparable specialist in protein expression that overlaps with BIBITEC's upstream platform.

Direct peers

• ProBioGen AG: Berlin-based CDMO specializing in mammalian cell line engineering, process development, and GMP manufacturing of biologics — directly overlapping BIBITEC's mammalian cell culture and complex-protein capabilities.
• Celonic AG: German biopharmaceutical CDMO offering mammalian cell-based GMP manufacturing and process development services, with comparable focus on mAbs and complex biologics.
• IDT Biologika: German biologics CMO with mammalian cell culture capabilities and a similar customer base of pharma and biotech sponsors needing clinical-to-commercial supply.
• Glycotope GmbH: German biologics company with proprietary glycoprotein-expression technology and CMO services — comparable in offering high-end glycoprotein and complex-protein GMP production.
• Richter-Helm BioLogics: German biopharmaceutical CDMO with mammalian cell culture-based GMP production for clinical and commercial supply, comparable in size and scope to BIBITEC.
• Rentschler Biopharma: German family-owned CDMO specializing in mammalian cell culture-based biopharmaceutical production, with a comparable end-to-end value chain from process development through GMP manufacturing for clinical and commercial supply.

Broad incumbents

• AGC Biologics: Global CDMO with mammalian cell culture capabilities serving clinical and commercial biologics supply — a much larger incumbent competing for similar mammalian CMO engagements.
• Charles River Laboratories: Global CRO/CDMO with biologics manufacturing capabilities acquired via its Cobra Biologics and other deals — a broad incumbent offering end-to-end biopharma services overlapping with BIBITEC's CMO positioning.
• Boehringer BioXcellence: Large German pharma's contract manufacturing division offering end-to-end biologics services including mammalian cell culture; competes for the same enterprise pharma and biotech contracts but at significantly larger scale.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bibitec-gmbh-&-co.-kg

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 BIBITEC GmbH & Co. KG