Name Address/P.O. Box Postal Code/City Country Telephone Fax Email Website Social Media Founded (year) Type of Laboratory
Areas of Activity
Biological Patents External Collaborations
Request for Further Collaborations
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ProJect Pharmaceutics GmbH
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Fraunhoferstrasse 22 82152 Martinsried Germany +49-89-45-22-89-700 +49-89-45-22-89-717 info@project-pharmaceutics.com www.project-pharmaceutics.com
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LI
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2010 Contract research and development; chemistry; cytotoxic; S1 (BSL-1); S2 (BSL-2) Analytical characterisation; preformulation screening; formulation development; freeze drying cycle development; lyophilisation process and scale-up; pre-clinical batch manufacturing; technology transfer Several patents in freeze drying and formulation Operating a network for seamless development from expert to expert, from pre-clinic to fill/finish. Competence network player as formulation specialist for DS and DP CMOs worldwide / process specialist for scalable drug products ensuring manufacturability. Cross-country competence hub with business partners in Asia. Credited laboratory for Wyatt Technology in Europe. We partner with small biotechnology, mid-size pharma, as well as large top players in pharma/biotechnology – from DSP development to early and late drug product phases up to life cycle management. We offer customised solutions for challenges in formulation, analysis or process and particularly for unmet needs not yet supported by the industry.
ProJect Pharmaceutics is one of the leading European CRO service providers specialised in formulation and manufacturing process development for parenteral drug products including biologics (rec. proteins, antibodies, fusion proteins), peptides, ADCs, cytotoxics, small molecules, generics, viral therapeutics, GMOs, ATMPs, VLPs, and other nanoparticular drug delivery systems. We pursue innovative, quality-by-design based, rational concepts of pharmaceutical development following ICHQ8 and other guidelines. We support our worldwide clients to develop a consistently high-quality pharmaceutical product, transferable, scalable, and manufacturable under GMP conditions. ProJect Pharmaceutics is led by experts with >25 years of experience in pharmaceutical industries. In about 850 m2 we operate dedicated labs for biologics, cytotoxics (OEL4), and a BSL-2 unit.
Drug formulation › Accelerated development – faster to clinic and market › Pre-formulation, early state, and late phase formulation › Liquid and lyophilised formulation (DoE-based)
High concentration protein formulation › › › › ›
Low viscosity formulation for s.c. application UF/DF process development Particle size distribution and aggregate analysis Analysis of subvisible particulate matter Viscosity determination & s yringeability testing in prefilled syringe or cartridge
Process and manufacturing › › › › › › › ›
Container closure system compatibility testing Thermal characterisation Forced stress studies Real-time, accelerated, and in-use stability studies Detergent and excipient quantification Fill&finish process mock-up Manufacturability assessment Aseptic pre-clinical batch manufacturing
Downstream process › Smart optimisation of UF/DF & purification steps › Stabilisation concepts (e.g. higher yield, decreased loss) › Testing for a common BDS and DP formulation
