The assesment of the appropriate and functional components in formulation development for biopharmaceuticals is a prerequisite for a market success of a new drug product. Formulation development support can start from the beginning accompanying the molecule development cyclewhen information on stability is not yet available. Protagen Protein Services (PPS) experts are highly experienced in the development of biopharmaceuticals including as ADCs, antibodies, fusion proteins, Fab fragments, vaccines and other formates. In a forward thinking way they can figure out specific formulation related questions for formulation optimization in e.g. early stage formulation development or late phase formulation and process development.
We support formulation development services for liquid and lyophilized drug product dosage forms for biopharmaceuticals and are performed integrating relevant container closure systems such as vials, stoppers and caps and appropriate drug product process manufacturing designs.
- Pre-formulation, Cevelopability, and candidate selection support
- Early stage formulation development
- Late phase formulation and process development
- Container-closure system selection and qualification
- Rapid automated high-throughput formulation screening
- In-use stability (simulated administration testing)
- Manufacturing of pre-clinical GLP drug product (e.g. toxicology testing)
- Long-term and accelerated drug product stability studies according to ICH guidelines
- Drug product manufacturing process setup and design, selection of unit operations and process ranges, selection of processing materials such as disposable tubing and filters and process development and characterization
- Technical transfer and scale-up support for clinical and commercial drug product manufacturing
- Regulatory support for Drug Product sections IND/IMPD, BLA/MAA documentation
PPS provides extensive support on formulation development and is currently expanding its analytical portfolio in that field. Up-to-date instrumentation allows high sample throughput and gives fast and reliable answers on many questions relevant for formulation development.
Among others, several orthogonal methods are in place to address aspects of higher order structure (e.g. by fast FT-IR analysis in aqueous solution), stability (e.g. by DSC equipped with autosampler) or aggregation behavior (e.g. by highly sensitive DLS or SEC-methods equipped with MALLS detection).