Thursday, March 6, 2014

How does one prepare for scale-up at an early stage to minimize problems in manufacturing?

Today, we continue our interview with Dr. Janet Wolfe. Today, she examines the scale-up at an early stage to minimize problems in manufacturing of antibody drug conjugates.

Understanding the structure of the antibody drug conjugate is essential to prepare for scale-up at an early stage. In the antibody drug conjugate you must not only understand the primary, secondary, tertiary and quaternary structure of the monoclonal antibody, but you also need to understand the solubility, stability and other aspects – other physical and chemical aspects – of the linkup payload. As an example, payloads in general tend to be very hydrophobic and that can cause inter and intra-molecular aggregation. This inter and intra-molecular aggregation can occur between payloads. For instance, they are plainer they can stack on each other. Alternatively, the payloads could interact with the amino acid residues in the monoclonal antibody.

So, understanding the inter and intra-molecular interactions between the payload and the monoclonal antibody peptide residues can be very beneficial. You can use this understanding – if you understand what the tendency to form the high molecular weight species, you can use that knowledge to then prevent the aggregation from occurring if you understand the forces that are causing it. To do that, it requires using an array of biophysical techniques to characterize what the forces are that are driving the aggregation.

Throughout her interview, Janet also examines key critical quality attributes, manufacturing, and the discovery/development continuum.  Download her full interview here.

Janet will be presenting Key Attributes and Considerations for Developing Antibody Drug Conjugate Formulations on Thursday, March 27 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.

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