ProJect Pharmaceutics GmbH was founded in 2010 and is headquartered in Martinsried, the Munich biotech cluster, where it operates about 850 m² of development laboratory space. Business development is also conducted from Boston, Massachusetts. The company reports 270 formulation, process, and CMC projects completed, 140 lyophilisation development programmes, and more than 250 stability runs. It also reports that 178 formulations have advanced to GMP manufacturing, of which 98 are in clinical trials and 80 have reached market approval. These are company-stated figures and have not been independently verified.

The company’s model centres on manufacturability: formulations are developed with the sponsor’s chosen manufacturer’s process mocked up at pilot scale, so the formulation transfers with critical process parameters and ranges defined. Each programme is staffed with one project manager and one lead scientist, and clients work directly with the scientists running their experiments. The company states that results are reported within five days, projects typically start two to four weeks after scope agreement, and average scientist tenure exceeds eight years. A Top 5 pharma client testimonial describes its flexibility, agility, and speed as more valuable than integrated capabilities.

The company does not manufacture GMP clinical supply. It produces aseptic, non-GMP preclinical batches and then transfers the formulation and process to the sponsor’s GMP manufacturer. Its facilities include cytotoxic containment up to OEB5 (SafeBridge category 4), BSL-1 and BSL-2 laboratories, and physically separated laboratories for biologics, cytotoxics, and live viral vaccines.

Key Products and Services

Formulation Development

• Liquid, frozen, and lyophilised formulations developed using design of experiments under a quality-by-design approach
• Preformulation screening to assess developability across lead candidates
• High-concentration and subcutaneous formulation, including viscosity and stability challenges for monoclonal and bispecific antibodies

Process and Lyophilisation Development

• Freeze-drying cycle design, optimisation, and troubleshooting, with pilot runs set to the limits of the manufacturer’s freeze-dryer
• Downstream process development, scale-up, manufacturability assessment, and process mock-ups before transfer

Analytics

• Analytical services and method development using chromatography, mass spectrometry, light scattering, and particle analysis, set up alongside formulation work

Stability and Clinical Use

• Accelerated, real-time, and forced degradation and stress studies following ICH stability guidelines
• In-use stability and clinical administration studies

Non-GMP Manufacturing and Technology Transfer

• Aseptic, non-GMP toxicology and stability batches, including ADCs and cytotoxic compounds
• Technology transfer to fill and finish manufacturers, with defined critical process parameters

Molecule and Application Focus

• Antibody-drug conjugates — formulation of the conjugate and its intermediates, including lyophilisation of linker-payloads from organic solvents
• Cytotoxic and high-potency APIs — formulation, compounding process development, and non-GMP batches under containment up to OEB5
• Antibodies, peptides, small molecules, viral vectors (adenovirus, AAV, lentivirus, and virus-like particles), and liposomes; the peptide, Fc-fusion, viral vector, and liposome pages are marked “coming soon” on the site

ProJect Pharmaceutics occupies a focused niche as a formulation and process development specialist for parenteral drug products, a stage where scientific depth matters more than manufacturing scale. Its non-GMP scope means it complements rather than competes with fill and finish CDMOs, and its manufacturer-specific process mock-ups address a common cause of delays when formulations move to GMP. Its strengths include high-concentration biologics, lyophilisation, ADCs, and cytotoxic compounds with OEB5 containment, which are technically demanding areas with limited specialist capacity. Its scale is small and project-based, with a lean team and a single laboratory site, which suits sponsors who value direct scientist access over integrated services.