ProJect Pharmaceutics
ProJect Pharmaceutics is a German CRO founded in 2010 that delivers formulation, lyophilization, and analytical process development for injectable parenteral drug products — including biologics, ADCs, cytotoxics, and viral therapeutics — serving biopharma, biotech, and CDMO clients across Europe, the US, and Asia from its Martinsried headquarters.
- Company typePrivate
- Founded2010
- HeadquartersMartinsried, Germany
- Headcount1–10
- GTM typeB2B
- OfferingServices
What ProJect Pharmaceutics does
ProJect Pharmaceutics GmbH, founded in 2010 in Martinsried near Munich, Germany, is a contract research organization (CRO) that delivers formulation and process development services for injectable parenteral drug products. The company specializes in technically demanding modalities — proteins, peptides, antibody-drug conjugates (ADCs), N-mustard cytotoxic drugs, liposomal systems, and live viral / gene-and-cell-therapy products (up to BSL-2 and GMO S2). Its technical foundation rests on a Quality-by-Design methodological base plus proprietary capabilities including Predictive Formulation Analytics (high-throughput screening via DLS, CG-MALS, and nanoDSC), Controlled Nucleation Technology, and Critical Pressure Scanning for lyophilization process optimization. The company operates dedicated OEL4 cytotoxic and BSL-2 viral safety laboratories, develops efficient lyophilization cycles that are described as reducible to a maximum of five cycles with secondary-drying sampling capability, and — as of December 2025 — extends analytical capacity with an Orbitrap Exploris 240 LC-MS system for multi-attribute analysis and native DAR determination of mAbs and ADCs.
ProJect Pharmaceutics monetizes exclusively through professional-services contracts (project-based fees), serving three principal customer segments: large biopharmaceutical companies, biotechnology firms developing novel biologics and ADCs, and CDMOs requiring formulation and lyophilization process development for client programs. Customer reach spans Europe (Germany, France, UK, Switzerland, Italy), the United States, and Asia Pacific (with BiGEN Co., Ltd. operating a Seoul-based Asian representative office routing inquiries back to the German HQ). Technology partnerships include LYOCONTRACT (GMP fill-finish manufacturing), Hof Sonderanlagenbau (pilot freeze dryers), and Teclen (Lyoprotect single-use bag systems). The company has developed formulations for over 25 ADCs with international top-tier pharmaceutical sponsors and runs regulatory-acceptable documentation (ICH, WHO, GLP-like, ISO) suitable for client submissions.
In September 2025, ProJect Pharmaceutics entered a partnership with Munich- and Frankfurt-based private equity firm Afinum Management GmbH to support its next phase of growth; founders Dr. Andreas Schütz and Klaus Hellerbrand remain as substantial co-investors and managing directors. The partnership is explicitly oriented toward international customer base expansion, service portfolio broadening, and targeted acquisitions. The firm also holds US Patent No. 11,752,135 (granted October 2023) covering a novel liquid formulation that stabilizes Bendamustine and related N-mustard anticancer agents at room temperature for up to 24 months.
ProJect Pharmaceutics firmographics
Firmographics- Name
- ProJect Pharmaceutics
- Legal name
- ProJect Pharmaceutics GmbH
- Website
- https://project-pharmaceutics.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- ProJect Pharmaceutics is a German CRO founded in 2010 that delivers formulation, lyophilization, and analytical process development for injectable parenteral drug products — including biologics, ADCs, cytotoxics, and viral therapeutics — serving biopharma, biotech, and CDMO clients across Europe, the US, and Asia from its Martinsried headquarters.
- Ownership category
- akta.pro rank
ProJect Pharmaceutics industry classification
Industry- Product category
- Pharmaceutical Contract Research Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)
- akta.pro secondary industries
- Formulation & Preclinical CMC Support (Nonclinical) (HLAGAFAL), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL), Solid-State Chemistry & Preformulation (Polymorph/Crystallization) (HLAGAHAI)
Keywords
Where ProJect Pharmaceutics is headquartered
LocationHeadquarters
- HQ city
- Martinsried
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
ProJect Pharmaceutics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Contract Research Services: CRO services for formulation and process development of injectable parenteral drug products, including drug substance and drug product development, lyophilization cycle development, analytical services, and technology transfer support. Revenue generated through project-based professional services contracts.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
ProJect Pharmaceutics product offering
Product offeringCore offering
ProJect Pharmaceutics provides formulation and lyophilization process development services for injectable parenteral drug products including proteins, peptides, ADCs, cytotoxic drugs, viral therapeutics, gene/cell therapies, vaccines, and liposomal systems. Operating as a CRO, the company offers drug substance and drug product development, lyophilization cycle development, analytical services, aseptic non-GMP preclinical manufacturing, in-use stability studies, and technology transfer to GMP manufacturing for biopharma, biotech, and CDMO clients worldwide.
Product overview
ProJect Pharmaceutics is a contract research organization (CRO) offering a comprehensive portfolio of formulation and process development services for injectable parenteral drug products. The core offerings include Drug Formulation Development, ADC Formulation Development, Cytotoxic Drug Development, and High Protein Concentration Formulations, supported by specialized Lyophilization Process Development (including Bulk Lyophilization Development) and Analytical Services and Method Development. Additional services encompass Aseptic Preclinical Batch Manufacturing, In-use Stability Studies, Downstream Process Development, Technology Transfer to Fill&Finish, Liposomal Formulation Development, and Live Viral Therapeutics/Gene & Cell Therapy/Vaccine development. A notable free service offering is the 'Check your Lyo Cycle' assessment for lyophilization optimization. The company operates dedicated cytotoxic safety laboratories (OEL4 and BSL-2) and has developed proprietary Predictive Formulation Analytics technology for accelerated formulation screening.
Differentiator
Problem solved
Functional benefit
Products and services
- Drug Formulation Development Quality-by-Design based development of parenteral formulations and innovative drug delivery systems for biopharmaceutics, cytotoxics, and viral/non-viral nanoparticular systems, delivered as a CRO service to pharmaceutical and biotech clients.
- ADC Formulation Development Innovative formulation and lyophilization process development for Antibody Drug Conjugates (ADCs), combining protein formulation and process expertise with cytotoxic drug knowledge to overcome ADC-specific stability challenges for biopharma and biotech clients.
- Cytotoxic Drug Development Formulation and lyophilization process development for cytotoxic and highly potent drugs including small molecules, generics, and Antibody Drug Conjugates used as anti-cancer therapeutics, leveraging dedicated OEL4 safety laboratories.
- High Protein Concentration Formulations Science-based development of high protein formulations for convenient use in pre-filled syringes, cartridges, and dual chamber systems, characterized by reduced aggregation, low viscosity, and smooth syringeability for biologic therapeutics.
- Lyophilization Process Development Development of efficient and robust freeze drying cycles for GMP manufacturing of all freeze-dried drug products, using high-end HOF pilot freeze dryers with process analytical technologies (PAT) including proprietary Controlled Nucleation and Critical Pressure Scanning technologies.
- Bulk Lyophilization Development Evaluation of critical bulk freeze-drying parameters and development of freeze drying cycles for bulk APIs or investigational bulk drug intermediates to obtain solid lyophilized cake or free-flowing lyophilized powder.
- Aseptic Preclinical Batch Manufacturing Non-GMP pilot batch manufacturing of pre-clinical batches for liquid and lyophilized drug delivery systems with assured sterility through permeable lyophilization bags, supported by valid documentation for pre-clinical study supply or Tox batch supply.
- In-use Stability Studies Evaluation of handling, material compatibility, and stability of injectable drug products during intended use in clinical trials, including compatibility with infusion media, storage stability, administration simulation, and adsorption evaluation.
- Technology Transfer to Fill & Finish Facilitation of technology transfer from development to GMP manufacturing, including primary packaging selection, container closure system compatibility, process mock-up studies, and scale-up support, often delivered in partnership with LYOCONTRACT.
- Analytical Services and Method Development In-depth analytical characterization of drug substance and drug product stability using state-of-the-art equipment including LC-MS, chromatography systems, spectroscopy, and thermal analysis for ICH stability testing.
- Downstream Process Development Rational design of cell harvest and protein purification steps in biologics drug substance manufacturing using Predictive Formulation Analytics to optimize chromatographic steps and avoid downstream processing product loss through aggregation or degradation.
- Liposomal Formulation Development Innovative GMP-compatible process for liposomal encapsulation of APIs and manufacturing of drug-loaded, lyophilized liposomes with high encapsulation efficiency, compatible with biomolecules and standard fill & finish equipment.
- Live Viral Therapeutics, Gene and Cell Therapy Products and Vaccines Formulation and lyophilization process development for gene and cell therapy products, live virus drugs, vaccine formulations, viral vectors (adenovirus, AAV, lentivirus), VLPs, and bacteriophages with safety requirements up to GMO S2 and BSL-2.
- Check your Lyo Cycle Service Free expert analysis of existing lyophilization cycles to identify optimization potential, product quality risks, technical weaknesses, scale-up risks, and opportunities for cycle length reduction.
- Excipient Quantification Service Analytical service offering for quantification of excipients including sugars, sugar alcohols, amino acids, detergents, buffer substances, antioxidants, and inorganic components using chromatographic and spectroscopic analysis methods.
Quantifiable outcome
- Reduces lyophilization cycle development to 5 cycles maximum using algorithm-based approach
- +1 more outcomes
Companies that use ProJect Pharmaceutics
Customer profileSegments3 records
Ideal customer profiles3 records
ProJect Pharmaceutics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature6 records
ProJect Pharmaceutics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- BiGEN Co., Ltd.coreBiGEN serves as Asian representative office of ProJect Pharmaceutics GmbH, providing local support and forwarding inquiries from Asian customers. Located in Seoul, Republic of Korea, BiGEN acts as the primary point of contact for Asian market engagement.
- LYOCONTRACTcoreStrategic partnership to provide pharmaceutical industry with high quality parenterals from clinical to large scale commercial scale. LYOCONTRACT operates state-of-the-art pharmaceutical manufacturing site with capabilities for liquid and freeze-dried parenteral drugs production.
Scale indicators6 records
Recent moves7 records
Expansion highlights6 records
ProJect Pharmaceutics competitors and assessment
Company assessmentDirect peers
- Ardena: Specialized CDMO offering drug product formulation, lyophilization cycle development, and analytical services for injectables and complex molecules, closely mirroring ProJect's core offering in small-batch aseptic and CMC enablement.
- Vetter Pharma: Established CDMO specializing in aseptic fill-finish, lyophilization, and complex injectable drug products; competes for the same formulation-to-fill-finish hand-off programs as ProJect.
- AGC Biologics: Global CDMO with biologics formulation, fill-finish and analytical services including for complex modalities, operating at much larger scale across mammalian and microbial platforms.
- Recipharm: CDMO with injectables and lyophilization capabilities serving biologics and small molecules across sterile fill-finish; a partner-competitor for late-phase tech-transfer work.
- Almac Group: Pharmaceutical services provider spanning formulation development, analytical services, and clinical manufacturing for sterile drug products, including lyophilized injectables.
Broad incumbents
- Lonza: Largest pure-play CDMO with biologics formulation, fill-finish, and ADC capabilities operating at global scale; offers overlapping services within a much wider portfolio and competes on enterprise programs.
- Catalent: Global CDMO with strong injectables, biologics and oral dose capabilities; serves as a dominant incumbent that sponsors often consider before specialty CROs like ProJect.
- Piramal Pharma Solutions: Integrated CDMO with sterile injectables, lyophilization, and biologics development services; competes for client share in formulation, tech transfer, and fill-finish.
- Eurofins CDMO: Large analytical-services and contract research network with significant pharmaceutical CMC/formulation testing capability relevant to ProJect's analytical services offering.
- BioReliance (Merck KGaA): Biologics safety testing and CMC services arm of Merck KGaA; serves similar biopharma clients for analytical testing and biosafety support and competes for portions of ProJect's analytical/CMC scope.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
ProJect Pharmaceutics social profiles
Digital presenceProJect Pharmaceutics compliance and trust
Trust signalCompliance4 records
ProJect Pharmaceutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
ProJect Pharmaceutics leadership team
Management profileNumber of profiles
Profiles2 records
ProJect Pharmaceutics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ProJect Pharmaceutics 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 ProJect Pharmaceutics
What does ProJect Pharmaceutics do?
ProJect Pharmaceutics provides formulation and lyophilization process development services for injectable parenteral drug products including proteins, peptides, ADCs, cytotoxic drugs, viral therapeutics, gene/cell therapies, vaccines, and liposomal systems. Operating as a CRO, the company offers drug substance and drug product development, lyophilization cycle development, analytical services, aseptic non-GMP preclinical manufacturing, in-use stability studies, and technology transfer to GMP manufacturing for biopharma, biotech, and CDMO clients worldwide.
Is ProJect Pharmaceutics a public or private company?
ProJect Pharmaceutics is a private company. It is classified as private equity controlled and is currently operating.
When was ProJect Pharmaceutics founded?
ProJect Pharmaceutics was founded in 2010. It employs 1 to 10 people.
Where is ProJect Pharmaceutics based?
ProJect Pharmaceutics is headquartered in Martinsried, Germany, in the Europe region.
How does ProJect Pharmaceutics make money?
One revenue line is on record: contract Research Services.
Who are ProJect Pharmaceutics's main competitors?
Direct peers on record are Ardena, Vetter Pharma, AGC Biologics, Recipharm and Almac Group. Broad incumbents are Lonza, Catalent, Piramal Pharma Solutions, Eurofins CDMO and BioReliance (Merck KGaA).
Does ProJect Pharmaceutics have an API?
No public API is recorded for ProJect Pharmaceutics.
What industry is ProJect Pharmaceutics in?
ProJect Pharmaceutics's product category is Pharmaceutical Contract Research Services. Its primary akta.pro industry code is HLAIALAD, CMC & Pharmaceutical Development (Formulation/Process/Analytical Development), with a secondary code of HLAGAFAL, Formulation & Preclinical CMC Support (Nonclinical). Its NAICS code is 541714 and its SIC code is 8731.