Opinion: Potent Compound Manufacturing – The Chicken or the Egg Problem

So your company has years of experience at being a pharmaceutical manufacturer. However, recently your business development (BD) professionals have been receiving requests that go something like this, “Can you handle potent compounds?” or “Can you handle Category 4 or 5 potent compounds?” Not wanting to say “no” and turn down potential business opportunities, the BD professionals consult with the management team. Then usually members of the management team gather around the table and discuss the market opportunities, the competition, the impact on existing operations, and what additional safety precautions or engineering controls are needed. Everyone is excited and wants to pursue this “opportunity” further. This is usually when Affygility Solutions receives a phone asking the question, “What do I need to do to handle ‘potent’ compounds?” Of course, without knowing a lot more about your goals and operations, that’s a very risky question for us to answer.

Potent Compound Manufacturing is a chicken or the egg problem

Prior to taking on projects that involve the handling of potent compounds that are Category 3 and up, it’s going to take an investment. However, often companies are willing to make the investment without having a sign contract for the project – and, no reputable client is going to sign a contract for their project without knowing that you are equipped to properly handle their potent compound. Hence, the chicken or the egg problem – which comes first? No sign contract = no investment, no investment = no sign contract.

Understand all the Business Dynamics of Handling Potent Compounds

Prior to just diving head first into the dark, murky waters of highly potent compounds (generally Category 3, 4, or 5) educate yourself in the business dynamics of potent compounds. Proper handling of potent compounds will impact almost every department in your company. Discuss amongst your team how it will impact the following:

  • How will you effectively market “potent compound manufacturing services?”
  • How will you train your business development, sales staff and operational personnel in this area of expertise? You want to make sure that you can deliver on any promises.
  • Are you willing to make the long-term capital investments in facilities, air-handling, and engineering controls to safely manufacture potent compounds? In addition, there will be ongoing operational costs in categorizing potent compounds, training employees, containment verification studies, maintenance of engineering controls, industrial hygiene monitoring, and “disposables.”
  • How will you on-board and categorize new compounds? How will you make “go” or “no-go” decisions? Just as important as it is to know what types of compounds you can handle, it’s equally as important to know what compounds or project are out of your league.
  • Once a proposal has been accepted, what type of risk-assessments will you perform for each step of the project?
  • How will you implement permissible daily exposure (PDE) or acceptable daily exposure (ADE) limits into your cleaning validation requirements? Note, depending upon the PDE/ADE value, it may require that you develop more sensitive and/or product-specific analytical methods.
  • Understand how all the above factors will impact the cost of a project. How will these costs be captured and passed onto the customer?
  • And, many others.

It takes a Commitment – both Financially and Operationally

No matter how much you debate above questions, at some point it is going to take a commitment, both financially and operationally. To do so otherwise is going to not be of value to the company or the client. Just “dabbling” in potent compound manufacturing has a low probability of providing the expected financial return.

If you would like to request an on-site gap assessment of your potent compound safety program, please contact Affygility Solutions.

 


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About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software