Finding A Contract Manufacturing Partner That Fits

Posted by David Watt

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file5311297827783Any journey of discovery begins with the first step and so it goes when seeking manufacturing and contract services partners. The likely goal of course is to find partners that “fit,” but getting to whatever constitutes a “good” fit relative to your organization is a process that one should start with a bit of introspection; sort of like “you can’t have a good relationship with someone else until you know who you really are first.”

What should a prospective contract manufacturing services buyer know about themselves before seeking a partner? A drug owner should have a thorough understanding of their internal systems, as well as clarity concerning potential synergies and the gaps in their capabilities that are not possible to address with available internal resources (or external for that matter) when looking for a manufacturing partner. A sound and “good fitting” manufacturing partner should be able to fill in the gaps, especially when it comes to manufacturing expertise, purchasing, logistics and Quality groups. A prospective contract services buyer should also be ready to share, augmenting and supporting the (in a manner of speaking) joint venture with a solid foundation of product and market knowledge.

For example, drug owners and innovators are likely better positioned for success with contract partners if they’ve vet the market’s potential and come away with an accurate forecast of potential demand. Armed with this wisdom a contract manufacturing partner will be much better equipped to create the manufacturing solutions necessary to effectively meet demand while seeking other cost advantages and production synergies.

What Should I Find Out First?

DSC_0390_Ivn_Melenchn_Serrano_MorgueFileGood due diligence starts with an understanding of how regulators and other concerned agencies view one’s prospective partner. The audit findings from the FDA, Health Canada or the EMEA and the associated citations for these groups are a good place to start and vitally important to determine the cGMP compliance history of a partner.

This should be followed by a thorough review of the prospective partner’s manufacturing, packaging and testing capability in the context of its general operations and determine its relative ability to manufacture and test your product to cGMP standards.

Another thing that initial due diligence should uncover is the economic stability of the company. Is it closely held public, or owned by venture capitalists? It’s ownership history as well as the legacies of its founders all provide excellent input when it’s time to evaluate the candidates and to determine who fits best.

Selection Criteria

While some drug owners may order them differently, the top selection criteria consistently include these Top 5:

  1. Compliance History
  2. Manufacturing Capability
  3. Experience
  4. Ethics
  5. Price and Service Quality

What characterizes a bad fit? Some might say ‘I know it when I see it’ but the following will likely drive a poorly fitting, poor performing relationship:

  • Lack of communication
  • High price
  • Quality Issues
  • Lack of experience
  • Constant hand holding
  • Delivery Issues

Who should be involved in the decision?

The decision to select a manufacturing partner can be a long process and should involve select, but comprehensive representatives from key operational and business segments of the organization to achieve better outcomes. Selecting a team of subject matter experts from Technical Services who can provide formulation, manufacturing and packaging expertise and Quality Services to provide quality systems guidance and audit services is a good place to start.

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook Regulatory Affairs  should be on board to guide the application and regulatory strategy—something that ultimately dictates the partner’s development and manufacturing, whether this be a simple Annual Reportable change, to a Prior Approval Supplement. Experts from the Purchasing and Planning group can and will provide direction with respect to materials, sales forecasts and vendors.

By necessity, the drug owner’s legal team will be involved in contract negotiation, supply agreements and confidentiality.

In addition, your company’s sales and marketing teams should be engaged early to lend a hand when it comes to understanding market potential,  forecasts for samples and ultimately, provide the prospective contract partner with the product’s consumer form and packaging platform whether its bottles, blisters or some other form like shelf units. This highly orchestrated team provides input into the successful selection of a manufacturing partner.

All In All, What Characterizes A Good Fit?

A good fit can come in a number of different forms, from the level of and satisfaction with customer service, as well as the project management expertise that a close partner can bring. A good fitting manufacturing partner transcends the merely transactional and becomes a seamless extension of your company, a turnkey operation that is as responsive as it is responsible, and elevate quality standards and ethics to the highest levels while delivering all that with a competitive price.

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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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