Drug Formulation Development
Formulation services from early stage formulation to late phase formulation: Development of injectable protein formulations, antibody formulations, and other parenteral formulation drug delivery systems for all kinds of biologics, recombinant proteins and protein conjugates, supported by formulation robustness testing and definition of design space for liquid and lyophilized injectable formulations.
High Concentration FormulationsA science-based approach to develop best-in-class high concentrated liquid or lyophilized formulations for convenient use in prefilled syringes and cartridges for subcutaneous injection (s.c.): pre-filled syringe formulations particularly featuring less aggregation, low viscosity and smooth syringeability.
ADC / Cytotoxic Drug Development
Formulation and lyophilization process development for cytotoxic small molecule injectables and other highly potent drugs and therapeutic cancer drug delivery systems, including stabilization of Antibody Drug Conjugates (ADCs) and other HPAPIs.
Gene and Cell Therapy, Live Virus Drug and Vaccine Formulations
Formulation and lyophilization process development for virus-like particles, bacteriophage, live virus and vaccines, and cell and gene therapy delivery systems (lentivirus, AAV and adenovirus formulation, lyophilization, stabilization).
Downstream Process DevelopmentDownstream processing / DSP optimization / process scale-up: the rationale design of cell harvest purification steps in biologics’ drug substance manufacturing, supporting drug substance formulation, accelerated DSP development and increased drug substance stability.
Lyophilization Process Development
Lyophilization cycle development: the art of developing efficient and robust freeze drying cycles which also work under conditions of large scale manufacturing, from aqueous solution or solubility enhancement-triggering organic solvent systems for poorly soluble drugs or liposomal formulation, supported by lyophilization process robustness testing and definition of lyophilization process design space.
Bulk Lyophilization Development
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 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.