Products We Support
Our consultants have the breadth and depth of experience to support a wide range of products to suit your needs.
Contact us today to learn what we can do for you.
Cellular and Immunotherapy Products
The number of cell therapy products in development continues to grow. These products offer tremendous promise for the treatment of grievous illness, yet each type of cell therapy product, whether allogeneic or autologous, present unique challenges. We have hands on experience with a number of cell therapy products and have dealt with and solved the problems many developers don't yet know they have. Put our expience to work for you and avoid the costly mistakes and delayed timelines.
Monoclonal Antibodies, Fragments, or ADCs
Development of antibodies to target specific receptors as a means of controlling biological pathways has become increasingly more common as a therapeutic avenue for managing various diseases. Whether you are developing an antibody (IgG1, 2, 3, or 4) or antibody fragment to directly treat an indication, or are using an ADC to deliver an agent, we have the know how to help you navigate from start to finish in the fastest and most efficient manner.
With decades of combined experience in the development, transfer and commercialization of protein based therapeutics, we can help you with all your needs. We have the expertise to support you from early stage discovery and expression vector design, creating relevant animal models, PK/PD and tox, through the latter stages of scale up, technology transfer, GMP manufacture, validation, and risk assessments, all the way through to your regulatory filings.
Recent changes in the regulations have made development and commercialization of biosimilars a practical reality. We are now starting to see approval of these products in various markets. Yet too often the complexities of the development of biosimilars are underestimated, causing significantly increased costs and delays. How do you take advantage of the accelerated pathway to approval? Let us assist you in getting it right the first time.