What are “3 Key Trends” shaping the CDMO industry in 2022 and beyond? Pfizer CentreOne’s Contract Manufacturing Lead, Tom Wilson, shares his thoughts with Contract Pharma.

Digital Transformation

COVID-19’s impact on global supply chains resulted in considerable disruption, particularly in the pharma industry. In retrospect, what was troubling about the challenges the industry expe-rienced during pandemic was that they were exacerbated by the same chronic supply chain is-sues plaguing pharma for the past decade or more.

It’s no surprise, then, that many CDMOs are rethinking their business priorities and focusing their attention on enhancing operational risk profiles.

For many CDMOs, the answer to this is the implementation of digital technologies and analyti-cal tools. Digital disruption of the pharma industry has been a recurring theme for a few years now, but I think calls for these new technologies are likely to grow too loud to ignore.

However, we have been here before—the case for digital transformation is clear, yet the in-dustry has been resistant to change in the past. If pharma is to break out of this inertia, many assumptions must be reconsidered, including the uptake and implementation of advanced digi-tal manufacturing and analytical technologies. These are the connected, collaborative tools the CDMO industry needs to accomplish increasingly faster development timelines and achieve the stable, secure supply chains that assure patient’s safe affordable access to pharmaceutical-based healthcare.

The Biologics Boom

The fight against COVID-19 spurred considerable innovation in the biologics space in particular. In addition to the rapid delivery of viable COVID-19 vaccines, we saw the development of a range of biopharmaceutical treatments to provide immunotherapy for patients hospitalized by coronavirus.

All of this growth has led to a boom in the biologics space. Some 61 new healthtech and 23 biotech unicorns were created in 2021, joining the 179 healthtech and 166 biotech companies founded after 2000 that have crossed the $1 billion milestone.¹ We can expect even more companies to reach this milestone in 2022 and beyond.

These biotech companies face challenges when it comes to successfully bringing their new dis-coveries to market. Biologics development and manufacturing is complex, requiring specialist equipment, aseptic processing and expert insight and support. Many new biotechs simply lack the infrastructure or in-house capability to develop their own discoveries themselves. Other biotechs may have partial capabilities or resources focused on core competencies and need to add to their suite quickly and efficiently in order to meet drug strategy and go-to-market time-lines. Specialist CDMOs with the dedicated biologics capacity will be well placed to support these companies in getting their innovations to market—we can expect CDMOs to invest in new lines and facilities in 2022 to accommodate this growth and support accelerating patient access to biotech’s amazing innovations and therapeutic breakthroughs.

OSDs for Cancer Treatment

Another key trend is the rise of oral solid dose (OSD) forms for cancer treatments as a more patient-centric alternative to parenteral administration.

However, this does pose a challenge for drug developers. Treatments for these conditions in-creasingly harness highly potent active pharmaceutical ingredients (HPAPIs) with poorly soluble chemistries, which require sophisticated formulation solutions to enhance bioavailability within the gastrointestinal tract.

Currently, a large majority of small-molecule OSD drugs in development are poorly soluble, with implications for CDMOs.² Depending on the specific chemistry of the API, creating a com-mercial-scale manufacturing process may require more steps and longer lead times. Develop-ing poorly soluble drugs for oral administration can be challenging and resource intensive.

Parenteral drugs on the other hand, can be developed, approved and brought to market faster because there are fewer steps to finishing a liquid drug product. However, the poorly soluble chemistry of today’s oncology APIs can make formulation challenging, requiring unique delivery systems and advanced OSD manufacturing techniques. From laser-drilling osmotic pumps to coating and compaction, several techniques are now available to create the highly functional delivery systems today’s cancer formulations need to manage side effects, dosing frequency and other patient-centered goals.

Nevertheless, patients prefer oral dosage, so for a growing number of developers, OSDs are worth the additional investment. With this in mind, if CDMOs want to support customers in developing innovative solutions for cancer and other serious conditions in 2022, they will have to invest in their own solubilization and formulation expertise and capability.

References
1. https://dealroom.co/blog/health-and-biotech-startups-no-let-up-in-record-breaking-funding-pace#:~:text=61%20new%20healthtech%20and%2023,crossed%20the%20%241%20billion%20milestone.
2. Kanikkannan N (2018). Technologies to Improve the Solubility, Dissolution and Bioavailability of Poorly Soluble Drugs. J Anal Pharm Res 7(1): 00198.

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Tom Wilson leads Pfizer CentreOne’s global contract manufacturing commercial business. Tom was formerly Vice President of Contract Manufacturing Operations where he was the liaison between the Pfizer Global Supply (PGS) and Pfizer CentreOne organizations. He also led the Pfizer Optionality Program for PGS, as well as the Integration Team for Hospira Device Opera-tions, oversaw management of Pfizer’s Alliance External Suppliers worldwide, and provided counsel on Pfizer’s global manufacturing strategy. He joined Pfizer in 2010 with the acquisition of Wyeth, where he was Vice President of Product Operations.

Pfizer CentreOne is a global CDMO embedded within Pfizer and a leading supplier of specialty APIs. Our global manufacturing network includes more than 35 sites across six continents. Backed by Pfizer resources, we deliver technical expertise, global regulatory support and long-term supply. For more than 40 years, we’ve been guiding complex compounds securely and efficiently from development through commercial manufacture. Working together with our customers, we combine our knowledge with open dialogue to solve challenges. Intelligent collaboration with Pfizer CentreOne.