Rentschler Biopharma SE

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Further Collaborations ProJect Pharmaceutics GmbH

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

LI

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 & syringeability 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

Proprietary liposome technology

› High encapsulation efficiency › Hydrophilic and lipophilic APIs › Cost-efficient aseptic manufacturing conditions

Freeze drying

› Rational cycle development (robust, collapse-safe, cost and time efficient) › Bulk lyophilisation (solid or powder) › Freeze drying out of organic solvents › Annealing and controlled nucleation › Easy lyophilisate reconstitution › Aseptic freeze drying › Robustness testing (definition of design space) › Smooth technology transfer and process scale-up › Lyophilisation in vials, (dual chamber) systems and syringes, bulk trays, containers in nest&tub configuration › Scanning electron microscopy (SEM) › Time lapse video and IR thermal camera monitoring

ADCs and cytotoxics

A deep understanding of the challenges when processing highly potent drugs, such as limited solubility in water and rapid degradation, paired with long experience and comprehensive know-how of lyophilisation from various organic solvents and solvent / water mixtures enables us to provide specific solutions for cytotoxics and ADCs.

Viral therapeutics and GCT products

› Virus particle stabilisation (lyophilised formulation) › Full factorial DoE formulation design › Aggregation tendency screening › Lyo cycle development › Aseptic pilot batch manufacturing

Fill&finish

As state-of-the-art development experts we are teamed up with state-of-the-art contract manufacturing experts to provide high-quality parenterals from pre-clinical to clinical and large commercial scale.