CMO Selection: Going from "Could Fit" To "Good Fit"

Posted by David Watt

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ID-100223938Where does one start? For most drug owners seeking contract manufacturing support, it all depends on the type of product that they have. There’s always a set of established criteria, but there are a few other things for partner-seeking companies to look at, but it really depends on the mix and the philosophy of the organization, their cost sensitivity, price sensitivity, how aggressive they want to be, etc.

The advent of ICHQ10 guidelines have made it more problematic to pursue an aggressive transfer strategy or manufacturing strategy. You’ve got to make sure that you recognize that dynamic and be careful about factoring that into your selection criteria, and ultimately, the decision to go with one contract manufacturing services provider over another.

The Start Of Your Selection Process

Assessment Qualification with a CMO PartnerThe selection process for companies seeking contract manufacturing partners begins by forming a CMO selection team, populating it with subject matter experts from around the organization. A list of prospective CMO’s is put together, most likely based on “Big Picture” manufacturing capabilities. If one is to manufacture a solid dose form, then a prospective group of solid dose manufacturers are identified and examined.

A company’s previous experience with potential partners and word of mouth continue to play a big part in early selection, as does accessing case studies, whitepapers, and news from industry media outlets. Don’t forget to make sure early due diligence includes a thorough tour of prospective company’s web presence as well. A well organized site, one that serves up a deeper understanding of the host organization and its capabilities in a straightforward manner is a boon that will support initial due diligence and making a solid, defensible choice. Once there is a good match with its capabilities, supported by media coverage and testimonials, it’s time to reach out to these prospects through the partner’s business development lead. By speaking directly with the business development group and receiving information about the partner, the customer can decide whether to carry to the next step of a CDA, followed by a Request for Quotation in a timely fashion.

Narrow Down Your List of "Could" Fits To "Good" Fits With These Criteria

But once you’ve populated your list (long or short) of “Could” fits, it quickly becomes time to narrow those down to the “Good” fits. What obvious things should be considered first as cut criteria? The following should be right up front:

  • Audit History – Citations and Observations
  • Communication – or lack thereof
  • Gaps in specific expertise

One definitely important aspect is audit history, including citations and observations from the various regulatory bodies all over the world. Next is communication – how well does the prospective partner communicate with you not later, but from the first line of contact. Do they show interest? Are they calling you back? It’s all about responsiveness.

ID-10080166Smaller virtual companies, with special needs for their formulation (like sustained or modified release), naturally would be reassured if that first discussion revealed the company has a specialized group in its organization to understand modified release technologies, how they function, and how you can work with your process intricacies.

Many formulations, modified release or not, require a specific piece of equipment to manufacture it. In some cases, the machines and manufacturing lines are based on dated technology and process. What happens if they go down? If you’re dealing with a product that is selling between $500 million and $1 billion a year, and you’ve only got one CMO, it’s not good.

Other Key Aspects To Consider When Filtering Your CMO Options

What not-so-obvious things should be considered? Negative news regarding operations or financials, testimonials, etc., and word of mouth opinions from peers, colleagues and other industry leaders should be proactively sought and then carefully considered.

Of course, the effort should be balanced with an equally weighted effort to ascertain the positive attributes and other criteria that can push the prospect into the “hire” column. Seeking and acquiring information on a prospect’s quality record, pricing structure, attention to detail, project management expertise and technical expertise all should be present in the decision mix.

What criteria should help decide who goes in the “cut” column? Well, it's evidence of the opposite from what was outlined above. Be it a litany of 483s, a Failure of Quality Audit, lack of knowledge, and poor organizational structure all should influence a “Won’t” fit decision.

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Topics: Partner Relationships

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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