Monday, September 16, 2013

#BPIConf 2013: Antibody-Drug Conjugates: Current Best Practices an Considerations for Processes and Facilities

Today, the 10th Annual BioProcess International event began in Boston.  Here are a few of the highlights form the Antibody-Drug Conjugates track.

During Dr. Leo Letendre of Pfizer's presentation Impact of 2011 FDA Process Validation Guidance on Process Development Strategy, he looked at the fact that Process Validation began as the collection and evaluation of data from the process design stage to the throughout the production, which establishes scientific evidence that a process is capable of consistently delivering quality products.  Over the years it has evolved to a life cycle with these steps, to name a few: 1) Process design 2) Process performance qualification 3) Continued process verification.  One key change with the new definition is that after a validation has occurred with an antibody drug conjugate, a company has to continue to monitor as we develop more information. This allows a company to potentially optimize more in the long run.  One key change to this is that companies in the process are now looking for optimization. Life cycle approach is an acknowledgement that we will continue to learn about our processes and continue to apply new data in a rational way.

In the presentation from Deborah Meshulam, MS, Immunogen, titled Assembling Teams to Manufacture ADCs: Realities vs Expectations, she looked at how to develop a team that can fully oversee antibody drug conjugates.  As an overview, benefits of antibody drug conjugates, there is a selective binding to tumors and longer half life. Cytotoxic agents are released into the cancer cell after it has attached. The type of linker on the ADC will tell what kind of tumor it should be used for. Antibody, linker, toxin: conjugated into substance then a drug product.

There are numerous groups involved in the manufacturing of antibody drug conjugates. How can a company keep all party members involved and engaged in the full production cycle?  Work to improve governance to ensure execution of decisions. Roles are clarified, responsibilities and the right parties are accountable. Each team should have goals and feel empowered to reach them. Across the board, teams should be prepared, participate and be proactive. Good teams feel empowered to manage themselves tactically Efficient and clear communicators; better faster cross functional decisions, consistent and timely data for better decision making are all benefits to this process. 

Project charters give each team an overview of the various products. They allow the teams to look at what decisions they should be making and what information can be factored in. Each antibody has a different team.

Tomorrow, we kick off the main conference.  Registration begins at 7:00AM, followed by a full day of presentations focused on Cell Culture, Rediscovery and purification, Formulation and Delivery, Analytical and Quality and Manufacturing Strategy.  Our Poster and Exhibit hall will open at 3:15 followed by our kickoff keynotes from 4:15-5:25.  We'll conclude our day with Oktoberfest, our evening networking reception in the exhibit hall from 6:00PM-7:15PM.

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