Ask The Board July 2011

Q. How can management support downstream development for a robust manufacturing process?
A. One of the most critical variables in process development is feedstream validation. Frequently downstream purification development is rushed in order to get an early “pass/fail” read on the molecule. This approach prevents a meaningful look at several different feedstreams. As a result, important variations in target protein modification and/or quantitative or qualitative host cell impurities cannot be taken into account during chromatographic range-finding and optimization. Almost invariably the downstream scientists are presented with a feedstream that is not representative of the final manufacturing process. This can result in misleading clinical observations if target protein modifications either have or have not yet shown up. Equally, a purification process may become “locked in,” which is either overly robust or insufficiently powerful to deal with challenging feedstreams. In addition, poorly characterized intermediate API standards can lead to analytical methods which cannot accurately analyze the ultimate set of API variability or analytical tests which, in the long run, are not meaningful.  

Mark Snyder
Prior to his current position at Bio-Rad Laboratories, Dr. Mark Snyder spent 13 years at Bayer HealthCare as associate director of process sciences in charge of the Purification Process Development Group.

Q: During an M&A, how do you prevent/reverse the “silo-ing” which often occurs with the merged/acquired company?
A. While acquiring companies often espouse a “do no harm” ethos during the negotiations, the reality is that most acquisitions create some level of duplicity/redundancy which needs to be consolidated. Even though both sides are aware of this issue, it often goes unaddressed until after the fact, which is where the trouble usually begins. It’s human nature for people to defend their value, and in doing so, silos are created and turf wars ensue. The best method for minimizing integration risk is to actually have an integration plan and process. If authentic and transparent conversations take place prior to closing and the integration plan and process mirrors said discussions, things will go as smoothly as can be expected. Good leadership and sound communication is never more needed than immediately prior to and immediately following an acquisition. Preemptive efforts are always more productive than reactionary responses.

Mike Myatt
Myatt is a noted leadership expert, author, and widely regarded as America’s top CEO coach. As a thought leader and columnist on topics of leadership and innovation, his theories and practices have been taught at many of the nation’s top business schools.

Q: How do I get started with a material risk management program without heavy investment?
A. The key to maximum ROI on a risk management program is prioritization. You can get started by baselining your risk exposure.

First of all, define the risk and impact attributes that are specific to your own organization. For risk attributes, you may want to look at single vs. dual source, supplier financial situation, safety stock, etc. For impact attributes, consider demand, where used, and inventory for each material.

Second, quantify your risks and impacts using a methodology agreed and understood by your entire organization. Try to plot all your materials on a 2 X 2 matrix and focus on your high-risk and high-impact category.

Third, review all the risk mitigation strategies, and estimate resources requirements. For any at-risk item, you may want to consider a combination of mitigation strategies, including safety stock, contractual agreement, alternative processes, or more frequent supply audit.

Yingming Yue
Yingming Yue is the associate director of supplier management at Nektar Therapeutics. Prior to Nektar, he was an operational consultant with Deloitte Consulting and PRTM. 

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