Pharmaceutical development for biopharmaceuticals - from formulation to process development.

ProJect Pharmaceutics offers pharmaceutical development services for:

  • product formulations and processes for all kinds of bio-pharmaceutic drugs like monoclonal antibodies, ADCs, cytotoxics, live virus vaccines, etc.
  • highly concentrated protein formulations e.g. for subcutaneous administration
  • protein drug delivery systems (liposomes, nanoparticles, composite scaffolds, etc.)
  • highly efficient and robust lyophilization processes from aqueous and organic solvents
  • process development for follow-on biologics / biosimilars
  • material supply for preclinical studies
  • technology transfer of fill and finish processes from pilot scale to clinical and commercial manufacturing
  • analytical method development and implementation for proteins, drug products and processes including accelerated stability testing

We deliver:

  • optimized liquid or freeze-dried formulations for biopharmaceuticals
  • tailored for parenteral, topical or inhalative administration
  • tailored manufacturing processes and transfer to GMP manufacturing
  • development reports ready for submission to regulatory authorities

Drug Formulation Development

Drug formulation development for all kinds of recombinant proteins and protein conjugates.

High Concentration Formulations

A science-based approach to develop best-in-class formulations for convenient use in pre-filled syringes and cartridges.

ADC / Cytotoxic Drug Development

Formulation and lyophilization process development for cytotoxic and other highly potent drugs, including Antibody Drug Conjugates (ADCs).

Gene and Cell Therapy, Live Virus Drug and Vaccine Formulations

Formulation and lyophilization process development for live virus vaccines.

Downstream Process Development

The rational design of cell harvest 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

Freeze drying of investigational bulk drug intermediates to obtain a solid lyo cake or free-flowing lyo powder.

Aseptic Preclinical Batch Manufacturing

Aseptic pilot batch manufacturing for liquid and lyophilized drug delivery systems supported by valid documentation.

Analytical Services and Method Development

In-depth analytical characterization of API stability using state-of-the-art equipment paired with high-end sophisticated technologies.