Person-in-plant expertise to support the contract research manufacturer

Relationship building has become an even larger priority now that sponsors have begun to transfer an increasing amount of their manufacturing to outsourcing partners.

This is where the person-in-plant becomes an indispensable source to create a more dependable relationship with the contract research manufacturer (CMO).

Person-in-plant expertise to support the contract research manufacturer

Image Credit: DSI, a PLG Company

A person-in-plant is essentially a sponsor employee or, more frequently, a third-party expert consultant who attends the contract manufacturing facility to support, observe and give feedback to all stakeholders.

Dr. Daniel Torok, senior drug substance consultant at DSI, a ProductLife Group company, is a process chemist with considerable experience in contract manufacturing and process development who provides a broad and deep perspective to solving challenges on the production floor.

When it comes time to go into a plant, either for a client who just wants somebody to watch over a registration campaign or validation campaign, or that time when the client calls on a Friday afternoon with a crisis because the batch is going up in smoke and they need someone there to help fix it, the 20 plus years I’ve spent in production facilities can provide a different and valuable perspective,

Dr. Daniel Torok, Senior Drug Substance Consultant, DSI, a ProductLife Group Company.

Why bring in a Person-in-plant?

A double benefit is achieved from having this external oversight. Firstly, the white coat effect tends to change the degree of attention given to a program.

Dan states that this is critical as the profit margins of the CMOs rely on close-to-full, or full, occupancy, which means extra engineers are simply not available to evaluate critical stages in a validation campaign.

Having a person-in-plant go and represent you covers that lack of additional attention during a time of need,” Dan states. “The key is you need to have the right person, and you need to start by building trust.

A person-in-plant with significant experience understands what occurs in a manufacturing plant and what to look for. For example, in large API facilities, operations may be performed over several different levels of the facility, and a batch may travel through all these levels in one afternoon.

An effective person-in-plant will collaborate with the manager of the plant in a collective manner, showing respect for the expertise of the individual and demonstrating that they are there to assist them.

Once you build that level of trust, they will begin to go to you with problems, which brings significant value to the sponsor,” Dan states.

After years of working in plants, I know almost every piece of equipment and can quickly tell if something isn’t right. For example, prior to the transfer of a validation batch, I noticed the operator didn’t have the cam lock properly fashioned onto the bottom valve, and they were about to try to transfer a batch. When that happens, it means losing the batch. I told him to check the cam lock on the bottom of the reactor, and after checking it he thanked me.

It is very costly to delay a clinical trial or reschedule a batch, even if it utilizes inexpensive materials. An experienced set of eyes being on hand to help the facility get it correct the first time significantly decreases costs.

Budget and planning

The decision to incorporate a person-in-plant should be vigilantly planned for smaller biotech businesses working with a restricted budget to establish at what stage an experienced set of eyes would be most beneficial.

The risks concerned with the production type should be assessed, and then the benefits can be deciphered.

Creating a basic drug substance most likely does not need that supervision, but an external perspective can provide greater benefit if the process includes filtration or crystallization, for example, with multiple days of heavy product manipulation.

When it comes to things like launching stock material, process validation, or critical clinical batch manufacture, where enormous oversight is needed, having a person-in-plant should be worked into the budget,” adds the head of operations, Brian Lihou from DSI.

Dan states that planning is crucial in budget management. The facility should choose when it wants the supervision on-site and what should be involved.

The external person-in-plant consultant may fly to a location, but during this time, they could be working on other plans if the main procedures are well spaced out, which enables great cost-savings for the client.

Adding value

The person-in-plant’s role goes above offering supervision at the manufacturing facility. A drug substance consultant with high expertise can also offer perspective on the physical chemistry mechanisms that occur, both good and bad.

When I’m returning from a site visit, I start to document observations while they are fresh in my mind,” Dan notes.

That might be concerns I have about batches I observed that weren’t a problem at the time, but could become a problem in the future, such as slower-than-expected filtration or product consistency, and to recommend some change control or remediation steps.

Brian explains that it is also crucial to call attention to what worked effectively.

As an example, a facility mechanic may have gone above and beyond to ensure the operation was progressing. Brain states, “These are all things that have to be in a well-rounded site wrap-up report.”.

A key factor to consider for any supervisor is to appreciate that procedures may not always be consistent for each cycle of production.

I was watching a validation campaign once where the operators from one night to the next did the batch transfer completely differently through the same equipment,” Dan states.

My jaw dropped, and we had some talks with the plant later about the pros and cons, but it made me realize that things aren’t always the same every time you go into production.”

“It’s important to be cognizant of that, but also to realize that the folks on the floor who are running the process, the person who’s writing your batch record, and the analyst handling your in-process controls all want to do a good job.”

“So as an observer, it’s important to treat them well. If you have to reprimand anyone, blame the plant manager, never the person who is turning the wrench for you at 3 a.m.

Showing empathy towards what plant operators frequently have to sacrifice to get the production process completed on time, building mutual understanding and appreciating the difficulties that they face is all part of developing a long-term, trusted and effective relationship with the CMO.

Acknowledgments

Produced from materials originally authored by Meranda Parascandola from Design Space InPharmatics LLC.

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: Mar 18, 2022 at 8:53 AM

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