Incentive Compensation Specialist

Catalent launches accelerated gene-to-drug substance program in US for complex biologics. The program is designed to help developers move next-gen molecules from gene sequence to drug substance in 10 months. October 5, 2026 Content Marketing Editor Editor's Take: As biologic pipelines shift toward more complex formats, accelerated programs can give developers a more predictable path forward. Catalent is launching an accelerated gene-to-drug substance program in the United States for complex molecules, namely biologics. The company says the offering complements its drug substance and drug product capabilities. The program helps developers move bispecifics, multispecifics, and other next-generation molecules from gene sequence to drug substance in 10 months. This includes later steps in the path including from bulk drug substance to fill-finish readiness. Biologics building blocks. Catalent says this builds on its Rapid Antibody offering, for traditional monoclonal antibodies (mAbs). This supports gene-to-GMP (good manufacturing practice) drug substance in as few as eight months. "For patients facing serious conditions, faster access to advanced biologics can be critical." David McErlane, Catalent Biologics Group President According to Catalent, biologic pipelines are shifting toward more complex formats. That being the case, accelerated programs can give developers a more predictable path from early development to clinical supply. Catalent's program combines its GPEx Lightning cell line development technology with integrated development and manufacturing workflows. Adding in U.S.-based execution, Catalent says it can bring complex biologics along at a speed usually associated with standard mAbs. Outline of Catalent process milestones. Specifically, Catalent's timeline for complex biologics involves three customer-facing milestones from gene sequence. Master cell bank conditional release is anticipated by month seven. Following this - bulk drug substance shipments to Catalent by month nine, and bulk drug substance lot release by month 10. "For patients facing serious conditions, faster access to advanced biologics can be critical," Catalent Biologics Group President David McErlane said. "Catalent is helping customers move complex antibodies through a defined, disciplined path to the clinic." A global CDMO, Catalent employs thousands of scientists and technicians at nearly 40 sites worldwide. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

ALK expands strategic tablet supply partnership with Catalent. September 30, 2026 09:03 ET | Source: ALK Abello Inside Information * Agreement provides long-term expanded access to Catalent's fast-dissolving (Zydis(R) tablet formulation technology. * Supply robustness secured with prioritised manufacturing capacity increase of ~40% to 1.1 billion tablets annually from early 2030s. * Over three years, ALK to invest DKK 500 million in capacity at Catalent. ALK (ALKB:DC / Nasdaq Copenhagen: ALK B) today announced that it has expanded its long-standing contract manufacturing partnership with Catalent, Inc. ("Catalent"), a leader in enabling the development and supply of better treatments for patients worldwide. Establishing long-term supply robustness is a strategic priority for ALK, and the expanded agreement secures ALK long-term access to Catalent's Zydis(R) technology for all its allergen products, including potential future tablets for peanut and tree nut allergies. The agreement also secures additional production capacity to sustain the expected future demand for ALK's SLIT (sublingual immunotherapy) tablet portfolio. Based on production sites in the UK and Canada, ALK expects to increase its annual tablet capacity by an additional 300 million to 1.1 billion tablets from early 2030s and beyond. Peter Halling, President & CEO, said: "We are very pleased to reinforce our long-standing collaboration with Catalent, which plays an important role in producing ALK's SLIT tablets. This partnership, already in place for more than two decades, has the potential to become one of the longest lasting in pharma. The expanded partnership underscores the unique durability of our core business model - with no patent cliff to manage - while the strengthened supply chain and added capacity secure our ability to serve many more people with allergy for years to come." Terms and financials Under the terms of the agreement, ALK will commit total payments to Catalent of approximately DKK 500 million to secure the capacity expansion. These payments will be capitalised over three years on the balance sheet under 'prepayments' and amortised over the duration of the contract. The development in future manufacturing costs is expected to offset these initial payments over time. The agreement does not affect ALK's financial guidance for 2026 or ALK's long-term financial targets. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This announcement contains inside information. This is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation. About ALK ALK is a global specialty pharmaceutical company focused on allergy. ALK's activities cover the entire value chain of developing, sourcing, producing, and marketing a diversified portfolio of products for diagnosing and treating respiratory allergies and severe allergic reactions (anaphylaxis) in both children and adults. Headquartered in Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen (Nasdaq: ALK B). Visit us at www.alk.net. About Catalent Catalent, Inc. is a leading global contract development and manufacturing organisation (CDMO) delivering tailored, end-to-end solutions across all phases of development and manufacturing for pharma, biotech and consumer health customers, and supplying billions of doses annually from nearly 40 global sites. Among its proprietary technologies is Zydis(R)[,] a freeze-dried orally disintegrating tablet formulation that disperses almost instantly in the mouth, offering a fast, convenient and palatable dosage form - particularly suited to patients, such as children, who may struggle with conventional tablets.