JHP Pharmaceuticals is not a very familiar name in contract manufacturing. Have you been at this a long time?
We have. Our Rochester, Michigan facility has performed contract manufacturing for over 25 years. In fact, we manufactured some of the first biologics for Genentech and Amgen, and the number of customers and products has kept growing since. JHP acquired the facility in 2007 and today, we provide contract manufacturing services to the broadest range of companies from virtual organizations to Big Biotech and Big Pharma. As you can imagine, there is quite a long-standing history with the site in supporting the industry.
Tell me about your service offerings.
We have two independent filling suites with an array of filling lines and freeze dryers for bio/pharma and ophthalmic/otic products. We have isolator technology, multiple packaging lines, and warehousing capabilities that go to -80O C, all backed up by an on-premise co-generation plant. We are licensed for controlled substances and make products from clinical through commercial. We have successfully launched and manufactured new products for companies all across the industry.
You mentioned that the facility has a long-standing history. What is new at the site?
There had been a good deal of investment over the years and since JHP acquired the facility, the rate of investment has really accelerated. And the investments are both in people as well as equipment. We have brought in talent from across the industry to support growth in our development, manufacturing and quality teams. We did this at all levels. It’s so important to keep a fresh perspective on how we do things; we never want to get complacent. On the plant and equipment side, we proactively modernized the filling rooms themselves from floor to ceiling. We have already validated a new 240 square-foot CIP/SIP freeze dryer this year and are completing validation of a brand new clinical filling line. Over the next 12 months, we are planning to move our laboratory equipment into state-of-the-art facilities to be constructed at the site. Overall, we have made proactive and targeted investments to continuously improve our skill base, compliance and capabilities.
Why a new clinical filler?
As I mentioned, we have a great deal of experience in manufacturing products from clinical through commercial and we have been doing the clinical work on our larger high-speed filling lines. Well, that certainly has advantages when it comes to scale-up, but we also would hear from our clinical customers of their need to ensure that the API/vial yield is maximized. We clearly understand that, given their high investment in the API and the nature of early clinical work when our customers are in the development mode and require not only yield but flexibility as well. With that, we have invested in a clinical filling line designed specifically to meet these needs. Our new filler is fully automated and integrated from vial washing through capping, provides minimal line loss which offers very high API/vial yield and uses all disposable product contact parts to help ensure batch integrity and reduce cycle time. It is designed to fill up to 3,000 vials per batch using a 20 liter disposable solution bag and can surely do more than that if required. Our new filler provides the scale-driven processing efficiencies sought by our customers during the clinical period of the program. Then our experience and capabilities are applied in launching and commercially- manufacturing the drug in a cost-effective manner. All with a seamless transition and a focus on yield, flexibility and cycle time. We are a one-stop shop supporting the product life cycle.
You are emphasizing flexibility and cycle time. Tell me more about that.
Flexibility and cycle time are tied together. Cycle time can be very nebulous yet so often drives the success or failure of a project. I’m not referring to fill or lyo cycles as those have technical boundary conditions. I am referring to the overall project timeline, from tech transfer to product release. There are many intangibles that must be managed and for me, these are so critical. Success here comes down to flexibility and, of course, project management.
A CMO takes the place of the customer’s manufacturing department. Customers want that same accessibility and transparency as if we were all part of the same company. And what this means is that the CMO must not only be accessible and transparent, it must also have the ability to rapidly respond to a need. This can be at the beginning of the project or, of course, at any time. The focus is on customer service and in meeting the customer’s needs. The requirement is flexibility. Let me give you an example. We had a new customer approach us, and this was actually with a commercial product. They were having supply problems and were looking for a new CMO. The timelines were extremely aggressive because of the need for this critical drug in the marketplace. So the industry-typical lead time of 4 to 6 months, from proposal acceptance to registration batch was not acceptable here. We worked to create and maximize the number of slots in our schedule and formed cross-functional teams with the customer and JHP staff. These teams and team members had clear areas of responsibility and accountability, as well as direct lines of communication. And all activities were coordinated by strong project management. When issues arose, as they always will, we pulled the right people together, even if they were not officially part of the established teams, to quickly address them. The result was that the time from when the customer asked us to support them to the time we made the registration batch was one month. Our ability to respond, apply resources and rapidly execute this program was instrumental to our customer and in reinstituting supply to the patients needing this critically-important drug. Many things needed to come together to achieve this short cycle time. And this effort certainly highlighted the underlying customer service principles that we strive to achieve on all of our projects.
You see the facility in operation day in and day out. What do you feel sets you apart?
I see several key factors that I feel that help set us apart.
I have already described our flexible, customer-centric approach and focus on cycle time. This, combined with a broad set of capabilities, clearly provide critical elements in meeting customer needs.
However, when you look at the overall regulatory landscape at present, you see that we are very strong in quality and regulatory compliance. It has to start here and you have to work on it every day. And the way we get to this is through the true, natural involvement between our quality and operations groups. The people within these groups interact routinely and constantly with a focus on bringing both of the groups’ perspectives together, real time, to ensure tasks are performed correctly. And when issues do arise, the focus is on resolution. That makes a big difference in meeting our time commitments to the customer and really helps set the tone and values within our organization.
On a larger scale, we have numerous improvement projects in place that are sponsored by our quality and operations leadership and involve cross-functional teams. These are driven towards continuously and proactively improving regulatory compliance and efficiencies. We use industry trends and best practices as a basis; again, the outside perspective as a way of elevating our performance and capabilities.
All of this rolls up to make JHP a cost-effective, reliable supplier centrally located in the US who serves customers whose drugs are distributed in 85 countries around the world.
We are a good size organization of over 300 people with a legacy in sterile product development and manufacturing. Big enough to provide depth of experience and breadth of capabilities, small enough to ensure focus. It is the best of both worlds. And yes, we are doing good things when it comes to proactively investing in plant and equipment, but as the facility leader, I can only echo what many in my position would say: it is all about the people and how they work together to achieve common goals in quality, on-time deliveries and, ultimately, in customer satisfaction.