The complexity and scope of gene therapy may give you multiple considerations for your assay strategies.
We have the experience and knowledge to help you navigate this complex area.
The diversity and inherent power of the immune system has paved the way for new types of cancer therapies. We can help with determining assay strategies, getting non-invasive analytical tools and establishing which technologies should be used.
It is paramount for a biosimilar to show comparability to its originator product - not only to ensure safety and efficacy, but also to allow for exchangeability. We help with assay strategy design as wells as with development of customized methods if no off-the-shelf solutions are available.
Recent advancements in drug development technologies have fueled the pursuit of new peptide drugs. We have a deep understanding for the requirements of assay strategies for peptides, and can assist with immunogenicity risk assessment and assay strategies.
An orphan drug is a pharmaceutical used to treat conditions so rare, that they are profitable without government assistance. Orphan designation qualifies for various development incentives and we can assist with risk assessment and assay strategies within relevant service fields.
With our long track record and extensive knowledge within the bioanalytical field we can help improve the basis for decision making and strengthening the position towards regulatory authorities for our sponsors.
