A number of patents for blockbuster biologics will expire in the foreseeable future, clearing the ground for the development of a growing number of biosimilars. Hence, alternative products for well-established blockbuster originators will be great opportunities for developers. At the same time the importance of new biological products as therapeutic options for various diseases is growing exponentially, and the development of first-in-class new biological entities (NBEs) is an economically appealing challenge. There is a distinctive need for more specific biopharmaceutical therapeutics in the market, and especially in nascent personalized medicine patients with serious rare diseases can benefit massively from tailored biologics in the future.
Instead of pinning their hopes on one singular format like mAb, ADCs, Gene Therapy etc., developers tend to put their efforts on the evaluation and identification of a vast scale of candidates of different formats, aiming at the development of a larger number of products with smaller expected economic results on an individual level, but with promising sales as a whole.
Paradigm Shift in Analytics
Increasing pipelines cause increasing demands for analytics. The more candidates you focus in order to properly select them, the less the application of traditional analytics will deliver the required solid results. „Only the most detailed knowledge at the earliest possible stage of development will guarantee the best and most reliable choices with regard to the developability of a candidate“, says Thomas Flad, Head of Business Development at Protagen Protein Services (PPS). This includes e.g. the earliest possible detection of critical quality attributes (CQA) and the comprehensive understanding of their specific linkage to a molecule‘s mode of action (MOA). Collaborating continuously with a single analytical CRO, starting with these first steps right through to the late clinical phases, is most beneficial for your success. A suchlike partnership will set a solid foundation and guarantee effective analytics without loss of information that inevitably would tend to occur due to precarious data hand-offs.
High-tech approaches, in particular MS technologies, such as the multi-attribute method (MAM), are able to deliver very concise and specific information from late research/early development on while at the same time allowing for high throughput and thus economizing time and costs. With more than twenty years of experience in the field of mass spectrometry and equipped with the most up-to-date devices and computational tools, PPS guarantees best support and guidance throughout the entire development process.
PPS – Your Partner From Clone to Clinic
Time savings, cost reduction and risk minimization are the undisputable triumvirate of success in the development of biopharmaceuticals. With regard to increasing demands for all-enclosing analytics PPS can guide you in developing your product from an early stage on. As your partner in drug development we help you to increase capacity, specificity and throughput. From cell banking and clone selection through to comprehensive process development and release testing services, PPS offers potent solutions that will be implemented in an individualized and context sensitive manner. Our approach is holistic and specific: We support you individually. Based on tailored solutions we offer clone-to-clinic support embedded in a unique partnership.
We will be happy to partner with you.