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
- 250+ projects successfully performed
- 180+ global clients from start-up to big pharma
- >99 % customers can keep their slot: Shorter lyo cycles than sectoral average
- >25 years of experience and knowledge in pharmaceutical industries
- >30 % of employees with > 10 years company affiliation
- < 4 weeks project start-up time
- Slim & reliable timelines from start to clinic
- Fee-for-service business model, no license fees, no royalties
- Working under our General Terms and Conditions (contract on demand)
Drug Formulation Development
Drug formulation development for all kinds of recombinant proteins and protein conjugates.
High Protein Concentration Formulations
A science-based approach to develop best-in-class formulations for convenient use in pre-filled syringes and cartridges.
Cytotoxic Drug Development
Formulation and lyophilization process development for cytotoxic and other highly potent drugs, including Antibody Drug Conjugates (ADCs).
ADC Formulation Development
Innovative formulation and lyophilization process development for Antibody Drug Conjugates (ADCs)
Virus Formulation Development
Formulation and lyophilization process development for live virus vaccines.
Liposomal Formulation Development
Innovative Liposome Technology: High Encapsulability & Superior Processability in GMP
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.
Technology Transfer to Fill&Finish
A strong network of expertise: Formulation. Lyophilization. Process. Primary Packaging. Technology Transfer. Manufacturing. Fill&Finish.
Analytical Services and Method Development
In-depth analytical characterization of API stability using state-of-the-art equipment paired with high-end sophisticated technologies.
Downstream Process Development
The rational design of cell harvest purification steps in biologics´ drug substance manufacturing.