- Several announcements this week sell a shorter timeline rather than just more capacity. Catalent launched a 10-month gene-to-drug substance program for complex biologics, Axplora says its in-house exatecan could take six to nine months off one part of an ADC program, and Piramal expects its new Lexington lab to cut testing times by up to 50%.
- Hovione, Olon, Andelyn, Upperton and Ofichem all announced moves to keep development and manufacturing with one partner. Executives at CPHI pitched the same continuity, and one of them, Piramal’s Stuart Needleman, was frank about where his own network falls short.
- US manufacturing showed up in deals from Ofichem, Alvotech/LOTTE Biologics, Hovione and Piramal/NP2. Not every executive said reshoring or tariffs were the reason.
At CPHI this year, CDMOs Sell Time and Continuity, Not Just Capacity
The week around CPHI Milan brought the usual run of CDMO expansions, partnerships and acquisitions. Read alongside what executives told PharmaSource on the show floor, a lot of it was about taking time and handoffs out of a program rather than adding raw capacity. Industry leaders say this, not price, is where buyers actually make their choice.
Timelines Are Becoming The Product
Catalent launched a US gene-to-drug substance program that aims to take bispecifics, multispecifics, and other complex biologics from gene sequence to drug substance in 10 months. The program builds on Catalent’s Rapid Antibody offering for traditional mAbs, which targets as little as eight months. The company published three milestones for customers: conditional release of the master cell bank by month seven, bulk drug substance shipped to its drug product site by month nine, and lot release by month 10.
Tracy Appleton, head of development services at one of Lonza’s UK sites, explained where the pressure comes from. Complex formats such as Fc fusions, bispecifics and high-concentration therapeutics used to be allowed more time. “Longer timelines were accepted because of the complexity of the molecule, and that’s no longer accepted anymore,” she told PharmaSource. Investors, she said, want data sooner. She also noted that “85% of our customers are small biotech, early phase, early entry into the market.” In her view, the risk sponsors most often overlook is “an assumption that the platform will be suitable.”
The same push for speed reached specific bottlenecks, too. Axplora CEO Martin Meeson said the company decided to make exatecan, an ADC payload building block, itself after hearing demand from customers. By keeping it in stock, he said, Axplora is “knocking six to nine months off the development and manufacturing time of that particular element” of a program. He described it as “not a massive investment in infrastructure.” At Piramal Pharma Solutions’ sterile site in Lexington, Kentucky, a new microbiology lab is expected to cut testing times by up to 50%. Charles River’s new Apollo Orchestrate moves GMP quality control testing records from paper to a digital workflow, with less time spent on review as one of the stated aims.
All of these are targets set by the companies themselves. None has yet been proven across a portfolio of programs.
One Partner From Start to Finish, With Some Caveats
The second pattern we noticed this week is continuity. Hovione’s $35 million ConsiGma CDC Flex continuous tableting line is due for commissioning in East Windsor, New Jersey, in late 2027. It will connect spray-dried amorphous solid dispersion manufacturing to commercial tablets “through one Hovione team and quality system.” Olon is linking its Saint-Julien, France, biologics and bioconjugation work with HPAPI and payload handling at Rodano, Italy. “Customers developing ADCs need more than individual capabilities. They need a partner that can connect them as a programme progresses,” said Maurizio Sartorato, vice president biotech at Olon, in the company’s announcement.
Other deals made a similar case. Andelyn Biosciences’ partnership with PQP Group makes Andelyn the single point of contact for sponsors shipping cell and gene therapies to clinical sites in the EU and UK. Upperton’s rebrand presents it as a single-site, end-to-end CDMO.
At CPHI, Jason Bertola, executive director of commercial development for North America at Lonza, applied the same logic to the company’s commercial spray-drying expansion in Oregon. He pointed to “that continuity” of running preclinical through large-scale commercial work at one facility.
Piramal’s Stuart Needleman, chief commercial officer and chief patient centricity officer, was more candid about how far a network can stretch. “Some of our clients want everything co-located, and we don’t have that capability,” he said. “So we have to work a lot harder than some of our competitors to give them that global feel but local presence.” His next internal priority: “How do I get the sites to work together on projects?”
Price is “The Easy Argument”
Continuity matters to buyers because of how they choose partners. Christelle Dagoneau, consultant at CD Biopartners, said cost is a fair basis for low-innovation commercial products. “But where there is a minimum of development or complexity at stake, what biotech and pharma partners actually choose on is something else: operational excellence, a true partnership mindset,” she wrote. In her list of those factors, she included “real harmonization of operations, quality and commercial across multi-site networks.” That is exactly the challenge Needleman described.
Meeson’s version came from the negotiating table. “If someone says they want a deep partnership, then immediately asks how much you’ll cut your price, that’s not my idea of a partnership.” Ofichem’s CEO, Dr. Weite Oldenziel, called GMP compliance a “hygiene factor,” meaning what sets suppliers apart starts after that baseline. Bertola made a related point about expertise: “Anybody can buy a piece of equipment, right? But buying the expertise is a lot harder.”
Supply is still a factor in some areas. Kindeva has installed a second Optima prefilled syringe line at Bridgeton, Missouri. Tommy Schornak, Senior Vice President & Business Unit Leader for Kindeva, told PharmaSource that despite the volume of capacity announced across the industry, “we’re still in a space where… there’s a lack of capacity” that customers can actually use now.
A US Footprint, for Mixed Reasons
Several deals added US manufacturing. Ofichem agreed to acquire Kinentia Biosciences in Rensselaer, New York, subject to CFIUS approval. Alvotech will source biosimilar drug substance from LOTTE Biologics’ 40,000-liter Syracuse facility, subject to tech transfer and regulatory approvals. Piramal and NP2 are developing generic cyclophosphamide at Lexington. They cite IQVIA data showing that the top two cyclophosphamide manufacturers, both overseas, account for 92% of US sales.
The reasons executives gave were not uniform. Asked whether onshoring or tariffs drove the Kinentia deal, Dr. Oldenziel said: “No, frankly speaking, not.” The aim had been on the company’s list for years, and the deal targets small US biotechs that prefer suppliers close to home. Kindeva’s representative said there is “a driving force still to onshore into the US.” Meeson said Axplora has invested in India for access to lower-cost manufacturing and added: “I would like to go back to much more globalization and much freer movement.”
Traffic also runs the other way. EUROAPI will supply European-made APIs to North American compounders through Medisca. Flamma is consolidating API capacity in Northern Italy by acquiring Lundbeck’s Padova site. In Dagoneau’s words: “Geography shapes costs and margins.”
Outlook
For buyers, the practical question is how to test the claims. When a CDMO quotes a timeline, ask what each milestone actually covers. Catalent’s “conditional release” of the master cell bank by month seven is a different commitment from a released lot. When a CDMO pitches an integrated network, check whether its sites share operations, quality and commercial practices, or just a logo.
Timing matters too. Much of what was announced isn’t available yet:
- Olon’s added ADC capacity: early 2027
- Flamma’s Padova acquisition: expected to close January 1, 2027
- GE HealthCare’s $945 million acquisition of SOFIE Biosciences: first half of 2027
- Hovione’s tableting line and Piramal’s full Lexington expansion: late 2027
- Curia’s sterile API expansion in Valladolid: Q4 2028
The open question is one that capacity figures can’t answer. If price is not the deciding factor for complex programs, how should a buyer measure the “operational excellence” and partnership that are supposed to replace it, before signing the contract rather than after?
CDMO Live Americas will be discussing these themes in just a few days, in Boston, 20-21 October. It’s not too late to secure your ticket!
