Catalent talks biologics, gene therapies and post-Covid activities at CPHI 2022 21st November 2022
At CPHI Worldwide this year, drug delivery, development and supply specialists Catalent took the opportunity to discuss accelerating development in biologics and gene therapies as well as oral outsourcing market trends.
The multinational corporation has recently announced a $12 million (€11.9m) expansion programme of its flagship facility in Kansas City, Missouri, to increase biologics CGMP analytical capabilities.
The facility will see the addition of two new analytical development laboratories to support growing demands in assay development for both traditional and advanced biologic modality programs.
“We have a significant biologics network and we’re seeing a corresponding uptick in the demand for bioanalytical services,” said Chris Halling, Senior Director, Communications at Catalent.
“Historically, we’ve provided bioanalytical services from our Morrisville facility in North Carolina, which is co-located with our inhalation facility, along with a biologics and small molecule lab.
“The demand now is such that we need to supply more local support and obviously Kansas City covers more of the west side of the US,”
“The expansion is to establish a biologics/analytics business, and largely appeal to new modalities such as cell and gene therapies and mRNA.”
The first of the two laboratories, which is now complete, will cover around 3,500 square feet, with the second 3,000-square-foot facility due to be operational in Q1 of 2023.
Expanding Catalent’s Singapore clinical supply facility
The addition of the laboratories complements September’s announcement of a $2.2 million (€2.1m) expansion to Catalent’s clinical supply facility in Singapore.
The investment allows the installation of 35 new freezers for ultra-low temperature (ULT) storage as well as increasing capabilities to handle mRNA-based vaccines, and cell and gene therapies.
Halling revealed the facility’s expansion was a “bigger investment” because it acted to serve that region.
“Our customers’ demands are not only to meet regional supply, but also to support large pharma companies based in Europe and America, who are looking to market to that area as well as regional players looking to market drugs outside of Asia.”
The investments Halling discussed form part of a recent reshuffle of Catalent’s operating structure in which the organisation reduced its four reporting segments to two – Biologics and Pharmaceuticals and Consumer Health.
The reorganisation, which was announced in July 2022, was, according to Halling, intended for “simplicity for customers as well as for Catalent.”
“There are essentially two business units to track but also continuity because we still report figures from the old business units,” he added.
Merging delivery tech and clinical supply segments
The Pharma and Consumer Health segment now consolidates what was previously the company’s Softgel & Oral Technologies segment, Oral & Specialty Delivery and Clinical Supply Services segments.
The segment will encompass the offerings of the three prior segments, including several important technologies such as its pharmaceutical and consumer health softgel capabilities, Zydis fast-dissolve platform, gummy dosage forms, as well as its clinical development and trial supply services offering.
“We’ve always sought to provide more than a traditional contract manufacturer,” said Halling. “The technology part allows us to become more of a partner to our customers and solve complex delivery challenges.
“Those technologies have become a key part of our business and are a key differentiator.”
In discussing the breadth of Catalent’s offerings, Halling pointed to a trend for customers to look for multiple differentiators, “A consumer health company will come to us and they may not only want a softgel, but instead will look at a portfolio of solutions. So, it enables us to offer softgels, gummies, perhaps a Zydis fast-dissolve format as part of a broader portfolio offer to them.”
Post pandemic strategy
In looking forward, Catalent is now moving to address the demands beyond the COVID-19 pandemic, as well as help resolve the supply chain issues that have affected the industry as a whole.
“The pandemic demanded large volumes of vials,” said Halling. “We were already scaling up facilities in Europe and the US to meet customer demand for vials and prefilled syringes.
“And then of course, the Covid pandemic came along, which meant that it was in our favour to accelerate those programmes and meet demand for Covid trials, and eventually for vaccines authorised for emergency use.
“That demand now is starting to soften,” Halling continued. “We’re still manufacturing doses for repeat vaccinations, and obviously there is demand for vaccines against new variants and for parts of the world that aren’t as well vaccinated as the western world too, but there’s no longer such a huge need to get massive volumes out for these vaccination programs.
“Now we’re kind of seeing a shift to single dose devices, which offer safety and administration advantages over vials.”