Multi-Specific Monoclonal Antibodies

whitePaper | January 31, 2023

The first biosimilar approved under the abbreviated pathway established by the Biologics Price Competition and Innovation Act launched in the U.S. in 2015.

whitePaper | March 16, 2021

Cell and gene therapies have emerged as a new treatment paradigm, and with them has come the potential to alter the course of many rare diseases. In many cases, there is an opportunity to correct the underlying dysfunction with a one-time administration of a therapy and provide either a functional cure or a substantial improvement in health outcomes. In other cases, long term symptom relief will be the primary therapeutic objective. Some of these indications may require more than one dose to achieve continued symptom relief and scientists and companies are working on technologies that will enable the use of a repeat dose.

whitePaper | May 27, 2023

The Human Genome Project was a monumental effort over more than a decade to determine the human DNA sequence and analyze genetic variation among individuals. The hope was that, armed with this understanding, phenotypic differences would be explainable by genetic variation, and health benefits could follow.

whitePaper | July 17, 2023

As your API demand grows, we grow with you. While we can manufacture volumes in metric tons, we can also go small. If you have a chemistry-based compound and need smaller batches for clinical or commercial use, we can offer the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.

whitePaper | August 5, 2022

The field of gene and cell therapy is experiencing a renaissance, with innovations in the use of viral vectors as a gene delivery vehicle being a key factor in the field’s growth.

whitePaper | December 5, 2022

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.