How one CDMO navigated the pandemic: Adversity, Adaption, Delivery, Expansion

The COVID-19 pandemic has changed pharma for good. Though we are now well past the two-year mark, the impact of the ordeal has changed the ways CDMO companies “think” and function.

Despite the rapid transformations thrust upon the sector, companies have shown a commendable level of dedication to their shared goal of improving patient lives. Many companies ran at full speed for every single second of the pandemic’s “unforgiving minute.” PCI Pharma Services is one such company. We asked some of PCI’s leaders to meet around the table to discuss the critical moves they made during this testing time and the choices that ensured the company’s growth in key areas, including sterile fill-finish and lyophilization capacity to support the increasing demand for end-to-end integrated solutions from development through to commercialization.

Adversity, Adaption, Delivery, Expansion How one CDMO navigated the pandemic and came out on top – August 2, 2022, | As seen in The Medicine Maker

With:
Tom McGrath
VP, Global Quality for Manufacturing & Development
Aimee Hodge
VP, Technical Services & Validation
Shawn Cain
Senior VP, Development & Manufacturing
Jeff Clement
Executive Director, Business Development, North America

How did COVID-19 affect outsourcing?

TM: As a company, we had to start doing business differently! As travel restrictions and shutdowns kicked off worldwide affecting our global development and manufacturing network, we had to both think differently to maintain operations as well as needing greater access to more local capabilities. We recognized that lead times would be affected, that we would need new “virtual” audit technology, and a shift to working online where possible to protect the site based operations. It was a real challenge, but one we were confident in addressing.
Supply chain issues flared up industrywide. At PCI, we took some proactive steps to minimize the impact. Literally hundreds of millions of vials and syringes were needed to create and deliver the vaccines and therapeutics the world so badly needed. Our clients were feeling both the stress of this overnight increase in demand as well as supply shortages, which included excipients, materials, and essential components.
SC: Some companies, PCI included, responded proactively. There was unprecedented demand for sterile manufacturing and lyophilization services and to alleviate some of the supply chain disruption and address our clients pressing timelines, we added a brand new sterile fill-finish line with additional lyophilization capacity at our Bedford, New Hampshire site, as well as doubling our lyophilization capacity at our Madison, Wisconsin site.

What else changed at the company during that time?

TM: During the pandemic, the safety and wellbeing of our employees was our primary concern. Safety of our employees is always front and center of what we do, but the pandemic took this to another level in terms of general health, wellbeing and the protection of our staff. Where possible, we supported employees in remote working and provided the necessary technology to enable this. To protect those in roles where remote working was not an option, we went above and beyond all mandated protocols at our sites globally; for example, implementing one way systems, segregating offices and production lines with screening, limiting the number of people in break rooms at any one time and the mandatory wearing masks at all times. Although our COVID-19 measures were very conservative, our teams are critically important to us and to our success in delivering life-changing therapies to patients and so we had to ensure that our workforce were able to deliver on behalf of our customers and patients. I’m proud to say we lost zero manufacturing days and although we, like every other business, experienced positive cases at our facilities, the protocols we had in place ensured that we never suffered an outbreak and we were able to maintain operations.
SC: Another noteworthy change would be that in the past, we would order materials on a project-by-project basis, however, at the onset of the pandemic we changed tack completely and, taking a proactive position, ordered large quantities of common components such as stoppers, seals and vials to ensure we were able to maintain supply. This change in purchasing strategy benefited everyone because it ensured that we were able to keep projects on track and ultimately ensure the supply of important therapies to patients when needed.
JC: Our clients were under massive pressure with time critical projects. With regular open communication and project updates through dedicated project teams, we addressed any concerns and navigated supply chain or manufacturing challenges. By providing flexible solutions, we were able to amend the schedule accordingly, so for example if one client was experiencing API supply chain delays and another was ready and eager to move forward along the development lifecycle, we could accommodate this.
AH: Flexibility also played into the way we handled the preparation for technical transfer through the pandemic. We went 100 percent virtual – which was very different to our existing business-as-usual model. We switched from in-person meetings to cameras, screens, and smart devices. It’s admittedly a little less warm and human, but it was what we needed to do to pivot quickly in the face of national lockdowns, supply chain breakdowns, and schedule disruptions.

How has your recent acquisition of LSNE helped boost your manufacturing capacity?

SC: The acquisition and subsequent integration brought about a welcome change for all. By joining the two companies, we have not only expanded our global manufacturing capacity but we have also expanded our collective expertise, something we began to feel the benefits of almost immediately. In areas such as health and safety, IT, finance, and HR, we were able to collate, share and implement best practice, allowing us to better focus on our core task: developing and manufacturing drug products for our clients.
TM: Another synergy of the PCI and LSNE acquisition is our desire to scale with and on behalf of our clients. To that end, we have committed to a $US100 million investment at our Bedford New Hampshire campus. This investment will see new capabilities and increased capacity all using state-of-the-art technology including high speed, large volume sterile fill-finish lines. We will also install isolator technology for drug products that are both sterile and classified as being highly potent to support our client’s from clinical stage development through commercial launches and ongoing market supply.
JC: We have also been looking at optimizing our end-to-end supply chain solutions to maximize the benefit of our sterile fill-finish sites and their close geographic proximity to both each other and the existing global PCI network. This ensures we are able to provide downstream complementary services such as clinical and commercial scale packaging, temperature controlled storage and distribution. Being a truly integrated CDMO is seen by clients as a definite advantage, especially in cases where the product in question has low stability for example. In such cases, we need to ensure that the drug product is manufactured, inspected, labeled, boxed, and frozen – all before it breaks from its liquid state, something you can only do with the appropriate logistics and integrated supply chains in place. Fulfilling this integrated supply chain need, we are currently building a Centre of Excellence in New England, USA to provide clinical packaging, storage and distribution including extensive cold chain solutions to support our sterile manufacturing operations in this region.
AH: Overall, our clients feel extremely positive towards this acquisition. There is a movement in the market towards reducing supply chain complexity and the number of vendors a company has to manage as part of a project and so many clients are looking for a CDMO able to operate as a “one-stop-shop”. By acquiring LSNE, planning significant investment in many areas including sterile fill-finish and investing in the latest technologies, we are demonstrating that we are serious about making this a reality for our clients and supporting their projects throughout the drug product lifecycle from development through to commercialization.

Post-pandemic, how will PCI’s world look?

SC: We will see the release of some pent-up demand, but we do expect more disruption to the supply chain. We are expecting a slowdown, and would not be surprised if it takes another year or more before we see any real improvements. On the upside, we do expect to see smaller scale, earlier stage clinical work return as biopharma companies reignite their development pipelines and seek expert support from CDMOs to progress their drug products through the clinical program.
JC: Another change we are already beginning to see is heavier state investment in new technologies. We will likely see proactive governments keen to stockpile medicines in readiness for any future crises – for example, bioterror or another pandemic and think they would go about this by spreading out stocks on a regional basis. With long-term storage requirements, many of these medicines will require lyophilization, and so this field of technology would need investment too.
Another change we are already seeing is a step back from full globalization. Think of companies who perhaps historically had API manufactured in Europe, sourced components from Asia, and then shipped it all back to the US. We may see those companies pull away from this model as they look to consolidate their supply chain either in one country or continent, or by seeking one global provider able to offer all services. This approach may not only help reduce the company’s carbon footprint but also assist in reducing lead times and mitigating supply
chain risk.

What things set you apart from other companies?

TM: Flexibility, experience and the fact we are a truly global, integrated CDMO but with the caveat that we are big enough to deliver but still small enough to care. We use our combined experience and expertise to guide small and midsize companies – from the minutiae of drafting applications to big picture questions, including the strategic goal of their entire business. One key aspect we try to instill is that there is never a one-size-fits-all solution as every client and project is unique and even within a single project, there may often be multiple routes to the same goal. This is the joy of CDMO life. The range of projects that we are exposed to and work with creates a wealth of combined experience across all areas of product processing and the associated quality and regulatory requirements. This ultimately provides clients with added assurance that they are working with a company who can and will deliver, safe in the knowledge that their strategy is viable.
JC: Our range of sites and their specialist capabilities is another major strength. Our global manufacturing capabilities include complex formulations, high potency solid oral and non-sterile liquids, and lyophilization covering a broad range of injectables including nanoparticles, mRNA, mABs, proteins, oligonucleotides, and other biologics across multiple delivery formats from vials and bottles to prefilled syringes and autoinjectors. Thanks to our capabilities, we can find a home for just about any project at any scale from early stage development through to global commercialization.

What other trends should we keep our newly-open eyes on?

JC: Undoubtedly, the increased demand for biologics. In the wake of the Pfizer and Moderna vaccines and mRNA technologies, much more investment will follow. Pre-COVID-19, most people hadn’t heard of mRNA technologies, but we at legacy LSNE started working on the development of mRNA medicines back in 2014, so we have a lot of experience in that product class.
We really do think an mRNA ramp-up is coming. It is seen a brand new technology under the media spotlight – and, whether from government investment or from the market, we think there is going to be significant investment in this technology and here at PCI we have the expertise and are more than ready!


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Our dedicated team of specialists will be happy to discuss any of your CDMO needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com