Services & Solutions

We also have vast experience in the conjugation of different linker-payload combinations. Beyond cytotoxins like auristatin, maytansine, PBD, and deruxtecan, we have achieved conjugation of proteins with non-toxic functionalities such as PEG, peptides and oligonucleotides.

Development of an extensive number of downstream unit operations and purification steps have been established for a wide variety of different bioconjugates including development of a series of platform purification technologies for ADCs. These purification schemes include UFDF and various column chromatography technologies such as IEX, HIC, and protein-A and utilize state-of-the-art instruments and equipment to perform custom processes of all types and scales. See the table for examples of the type of instruments and equipment utilized in our conjugation/purification laboratories and pilot manufacturing facilities.
 

Based on the contemporary concept of Quality by Design (QbD), we optimize processes by focusing on critical quality attributes (CQAs), and scale-up from the processing of micrograms to hundreds of grams to achieve controllable and stable pilot / non-GMP and GMP manufacturing. We have the capability of generating more than 50 batches (hundreds of grams per batch) of non-GMP products per year.

 
Under the Quality Assurance (QA) system, the Process Development team strictly adheres to quality practices and manages personnel, equipment, materials, sites and documents (e.g., SOPs, changes, deviations, corrections, and preventions) to help ensure right-first-time execution.