Formulations for Pioneering Drugs

ProJect Pharmaceutics offers formulation and process development for parenteral drug products to the pharmaceutical and biotech industry.

Drug Formulation Development​

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 Formulations

A science-based approach to develop best-in-class high protein formulations for convenient use in pre-filled syringes, cartridges and dual chamber systems.

ADC Development / Cytotoxic Drug Development

Formulation and lyophilization process development for cytotoxic drugs (small molecule drugs, generics) and other highly potent drugs, including cytotoxic drug immunoconjugates (Antibody Drug Conjugates (ADCs)) used as anti-cancer drugs.

Live Viral Therapeutics, Gene and Cell Therapy Products & Vaccines

Formulation and lyophilization process development for gene and cell therapy products, live virus drugs, vaccine formulations and viral and non-viral nanoparticular drug delivery systems.

Accelerated Downstream Process Development

The rationale design of cell harvest protein purification steps in biologics’ drug substance manufacturing.

Lyophilization Process Development

The art of developing efficient and robust freeze drying cycles which also work under conditions of large scale manufacturing.

Bulk Lyophilization Development

API Lyophilization services: Evaluation of critical bulk freeze-drying parameters and development of freeze drying cycles of bulk APIs or investigational bulk drug intermediates to obtain a solid lyo cake or free-flowing lyo powder appearance, either filled into permeable lyophilization bags / trays or into conventional freeze drying stainless steel trays.

Aseptic Preclinical Batch Manufacturing / Non-GMP Pilot Study Supply

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.

Analytical Services and Method Development

In-depth analytical characterization of drug substance and drug product stability using state-of-the-art equipment paired with high-end sophisticated technologies.