Regulatory, cGMP, and CDMO Challenges: A CPHI Conversation with Lonza Capsugel, Part Two

Concluding a two-part interview at CPHI Frankfurt, Frank Romanski, PhD, vice-president of Strategic Growth & Revenue Management and head of Global Pharma Solutions at Lonza Capsugel, spoke to Pharmaceutical Technology® about the importance of adhering to current good manufacturing practice (cGMP) guidelines in a world in which regulatory shifts and an ongoing push for digitalization are constantly keeping companies on their toes.

“This is really a license to operate in this space,” Romanski says in the interview. “This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.”

The move to digital recordkeeping in particular, Romanski says, is in many ways unavoidable for pharmaceutical companies—and it is crucial.

“The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things,” he says. “And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity.”

Of course, contract development and manufacturing organization (CDMO) partners must align on these standards, making quality even more paramount, according to Romanski.

“Once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing,” he says in the interview. “We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.”

Click here to watch Part One of the interview.

Click here for all of our CPHI Frankfurt coverage.

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Frank Romanski. I head the Strategic Growth and Revenue Management group and am the head of the Global Pharma Solutions business at Lonza Capsugel.

I know that your audience in particular knows the criticality of cGMP manufacturing. This is really a license to operate in this space. This reduces risk, this manages product recalls. We're ensuring consistent product quality, simplifying regulatory approval processes, and ultimately saving costs and conserving resources in drug manufacturing.

For us at Lonza Capsugel, let's talk about two different pieces of this. We of course have the drug product manufacturing facilities, which always operate under the appropriate cGMP. But I want to talk a little bit about the capsule side of the business, the excipient side of business, if you will. Our manufacturing facilities are independently certified for the appropriate cGMP standards, and we do that across our entire network. We have a network of sites that go in all of the major different markets, and we operate each one of them at the appropriate cGMP standards. And we set a global bar so that there's interchangeability and there's robust supply chains that can be brought to our customers.

We also offer to our customers comprehensive regulatory support, compliance support, to help drug developers navigate these pathways all the way from the concept into the clinic, into the commercialization pathway, and we have a very strong track record of commercial drug manufacturing.

One other thing that I think is really important that we're putting a lot of emphasis on is digitalization. The world of regulatory and quality has a tendency to be very heavy on the paperwork side of things. And if you're not leveraging the digital technologies that we have today, I think it's a missed opportunity. So what we have done is we've taken a lot of our paperwork that [is] needed for our clients, with which to interact with regulatory authorities, quality agencies, etc., and we've put that all online in our ACHIEV portal. And this enables people to have a one-stop shop, [you] don't need to call somebody on the phone, you don't need to use a fax machine or some of these technologies that are long outdated. You can get everything online. It's always up to date. You get notifications when things change, etc.

And finally, as we're producing our products and our services, we're always building quality-by-design into those products themselves, and we're leveraging a tremendous amount of technology to make sure that we are consistent always with those highest standards.

When it comes to making drug product, it really starts with a lot of the raw materials that are being used. And something that, of course, at Lonza Capsugel, we can speak very intelligently about is the capsules themselves. In order to make them to the highest standards, we really have to start with the quality of the raw materials. And we work with all of our partners in the supply chain when we're sourcing things like gelatin or HPMC (hydroxypropyl methylcellulose), which are the bedrock of the capsules that we're ultimately producing.

We have really robust quality management systems, and really, we set the bar in terms of industry-leading standards across our network. We're also a founding member of EXCiPACT, which is an independent third party that really sets the standards for excipient manufacturing. And that's something that has been really quite important of late, because as most manufacturers are also manufacturing excipients for different parts of different industries, it's really important that on the pharma side, that we're all following the appropriate cGMPs.

In addition to that, we continue to really focus on the processes that we have. We document everything that's there. And once you get downstream and you start talking about the CDMO sites that we manage, this is something that's, of course, absolutely critical to what we're doing. We really embed quality into every step of our manufacturing processes, all of the interactions that we have with our clients, and with any agencies that they're in.