ProJect Pharmaceutics GmbH
About us
ProJect Pharmaceutics is a leading formulation and process development partner (CRDO) for liquid and lyophilized parenteral drug products in preclinical to commercial stages across all therapeutic modalities, including antibody drug conjugates (ADCs), recombinant proteins/biologics, cytotoxics, and live virus vaccines.
As specialists, we integrate Quality-by-Design principles into pharmaceutical formulations and drug-device delivery systems to maximize stability, safety, and administration convenience.
Address
Fraunhoferstraße 22
82152 Martinsried
Germany
E-mail: info@project-pharmaceutics.com
Phone: +49 161 78349971
Internet: project-pharmaceutics.com/
Contact person:
Products & Services
Schedule a time to meet with ProJect Pharmaceutics during BIO
Formulation Development services
Formulatability assessment / predictive formulation analytics
Formulation optimization and platform formulation robustness testing
Liquid, liquid/frozen, lyophilization formulation development
High concentration (re)formulation development
(Accelerated) Stability studies
Material/device compatibility and primary packaging studies
Clinical administration and in-use stability monitoring
Analytical, Process, & Manufacturing Services
Analytical method development
Manufacturability assessment & drug product process simulation
Stability & toxicology batch manufacturing (non-GMP)
(Bulk) Lyophilization process development (pilot-scale) and tech transfer
Lyophilization cycle optimization and robustness testing
Formulation Services
Quality-by-Design based drug formulation development: development of parenteral formulations and innovative drug delivery systems for all kinds of biopharmaceutics, cytotoxics and viral/non-viral nanoparticular systems.
High protein concentration formulation development
Cytotoxic drug formulation development
Live Viral Therapeutics, Gene and Cell Therapy Products & Vaccines
Clinical administration & in-use stability testing
Evaluation of handling, material compatibility and stability of an injectable drug product during the intended use in clinical trials.
Non-GMP Manufacturing Services
Non-GMP pilot batch manufacturing of pre-clinical batches for liquid and lyophilized drug delivery systems: ensured sterility through use of permeable lyophilization bags, and supported by valid documentation for pre-clinical study supply or Tox batch supply.
Lyophilization Formulation & Cycle Development
The art of developing efficient and robust freeze drying cycles which also work under conditions of large scale manufacturing.
Lyophilization process development
Drug-Device Combination Services
A strong network of expertise: Formulation. Lyophilization. Process. Primary Packaging. Technology Transfer. Manufacturing. Fill&Finish.
Analytical Services & Method Develompent
In-depth analytical characterization of drug substance and drug product stability using state-of-the-art equipment paired with high-end sophisticated technologies.
Accelerated Downstream Process Development
The rationale design of cell harvest protein purification steps in biologics’ drug substance manufacturing.
