George Petroka, Director of BioPharma/EHS Services at IES Engineers, and Ray Ryan, Founder and President of Flow Sciences, Inc., sat down recently to talk about trends the two saw in the pharmaceutical production and manufacturing industry. The conversation quickly turned to contract manufacturers and the need for better controls and systems for employee safety and product quality.
Question: There’s a lot of pharmaceutical industry experience in the room today. What are some of the issues that are popping up that you two see coming up for customers shopping for isolators from Flow Sciences and lab solutions and for clients looking for consultation and certification from IES Engineers?
George Petroka: In pharma, definitely contract manufacturing. It’s going to be more and more the trend moving forward. Five, six years ago, pharmaceutical heavyweights weren’t doing any of it, now I know of several companies moving to that model. I know of one looking at a 50 in 15 or 50 in 5 plan, meaning they want to have 50% of their manufacturing outsourced in 15 years or even 5 years.
Some contract manufacturers will have facilities and operations outside the U.S., some will be here. That leads into the idea of cross contamination and it leads to even though companies are going to contract manufacturing, they are setting standards they want to meet.
Q: So, with operations overseas and in the U.S., that means contract manufacturers have to follow the guidelines set out by the FDA and other oversight agencies?
George Petroka: Yes. The main driving [standard] is quality [as seen from] the FDA or oversight agency’s view. The other is environmental health and safety factor. Companies want to make sure that if a contract lab is making something potent or cytotoxic, [the lab is] handling it safely so they don’t have liability. Once you go out to a contractor, that contract firm has the potential to go sue the big pharma company they’ve contracted with because they’re not protected by workers comp as if they’re full time employees.
Ray Ryan: One of the things I’m seeing is that the contract manufacturers don’t have the expertise that the manufacturer routinely had. As a result, the need for education has increased dramatically as well. That’s one of the big things. The rush to get into the contract manufacturing has caused some other issues. We deal with contract manufacturers who call us up and have no idea about containment. The question that comes to my mind is how did this come about that these people, who aren’t bad people, they’re smart, they’re good at parts of their job, but they are clueless when it comes to containment.
George Petroka: They see a business opportunity and someone comes to them and says, “You’ve been making aspirin, can you now make something far more potent at a smaller dosage?” That’s obviously a big difference in potency and also a big difference in someone being exposed or a small amount of material being carried over.
Q: When you talk about the rush to manufacturing and some of the issues that come up with contract manufacturers, you talk about the increased need for education. What do you mean by that? Increased education on what side, a formal education, application or product specific education?
Ray Ryan: Here’s what’s going on. You have these companies who are down to virtually no manufacturing in the U.S., and almost no manufacturing in their own facilities. They outsource to contract manufacturers in the U.S. and China. What happened is they had a cadre that was well educated in the proper handling of Active Pharmaceutical Ingredients (APIs). Now they’re farming it out to companies who’ve never worked on the APIs. As George was saying, you have permissible exposure levels that are much lower and people who have no idea how to handle those things. So, you have an organization with a level of expertise who farms out manufacturing to a company without that experience or expertise and the number of problems can be quite significant.
George Petroka: I will say that it’s gotten a lot better over the last 10 years. The companies are aware of the issues – sometimes as a result of big pharma workers going to these companies after retirement or downsizing. Or, they’re being driven by big pharma who are saying, “You can make it for us, but you have to meet these criteria.” And they’re saying, “What do we do? We don’t do that, so what do we do?” They need education and better engineering controls.
Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.