Quality Systems Manager

Helium-Free gas chromatography. Abstract: This case study highlights Catalent Nottingham's development of a helium-free gas chromatography (GC) solution using nitrogen as an alternative carrier gas. In response to global helium supply challenges, validated methods were created to seamlessly convert helium-based GC methods to nitrogen without compromising analytical performance. By optimizing column dimensions and flow conditions, the approach delivers efficient separations, reliable data, and even faster analysis times. Supported by advanced instrumentation and expert analytical capabilities, Catalent enables pharmaceutical companies to maintain continuity in analytical workflows while reducing dependence on helium.

Catalent, a global contract development and manufacturing organisation, has launched Qai, an enterprise AI tool designed to enhance quality management systems across its manufacturing network. Built with Microsoft using Azure AI technologies, including Foundry and Fabric, Qai strengthens quality processes such as deviations and complaints by accelerating analysis, root cause identification and corrective action development. The AI-enabled solution integrates intelligent insights into existing quality workflows, enabling faster decision-making whilst improving consistency and speed. Qai represents Catalent's first enterprise AI solution, marking a significant step in its digital transformation efforts. The platform aims to support pharmaceutical and biotech customers by reducing repeat deviations, accelerating reporting and minimising documentation delays, ultimately improving patient outcomes whilst maintaining compliance across Catalent's nearly 40 global sites.

Catalent and Elpida Therapeutics enter strategic partnership for late-phase AAV manufacturing. - May 13, 2026 Why it matters. Securing manufacturing capacity ensures the SPG50 therapy can reach patients and progress toward regulatory approval, while giving Catalent a foothold in the expanding ultra-rare gene-therapy market. Key takeaways. * - Catalent gains exclusive rights to manufacture Elpida's AAV pipeline * - SPG50 therapy targets ultra-rare AP4M1 mutation neurodegeneration * - UpTempo(TM) platform accelerates GMP-grade AAV production for late-phase trials * - Catalent has supported over 80 gene therapy programs, four now commercial * - Partnership aims to prevent therapy discontinuation before regulatory filing Pulse analysis. The contract development and manufacturing organization (CDMO) sector has become a critical engine for the booming gene-therapy market, especially for adeno-associated virus (AAV) vectors. Catalent's UpTempo(TM) platform, built on a proprietary HEK293 cell line and off-the-shelf plasmids, shortens timelines for GMP-grade material and reduces the technical risk that has historically slowed late-stage development. By offering end-to-end capabilities - from cell line optimization to analytical assays - Catalent positions itself as a go-to partner for biotech firms seeking to scale complex biologics without building in-house capacity. Spastic Paraplegia Type 50 (SPG50) exemplifies the challenges of ultra-rare diseases: a tiny patient pool, high unmet need, and limited commercial incentive. Elpida Therapeutics, a non-profit biotech, focuses on advancing such therapies that larger companies often deprioritize. The partnership with Catalent ensures a reliable supply chain for the AAV9 gene therapy, enabling the company to complete process validation and file a Biologics License Application before the year's end. This collaboration also grants Catalent exclusive manufacturing rights to Elpida's broader AAV pipeline, potentially expanding treatment options for other rare neurodegenerative conditions. Industry observers see this deal as a bellwether for how CDMOs can de-risk the late-phase segment of gene-therapy development. With more than 80 programs under its belt and four commercial products already launched, Catalent demonstrates that scale and expertise can translate into faster regulatory pathways and broader patient access. As investors and payers increasingly scrutinize cost-effectiveness, the ability to produce GMP-grade AAV at commercial scale will be a decisive factor in bringing ultra-rare therapies from bench to bedside. The Elpida-Catalent alliance therefore not only safeguards a single therapy's future but also underscores a growing business model where non-profit innovators rely on specialized manufacturers to navigate the complex path to market. Avada Temp Catalent to Support Gene Therapy Manufacturing for SPG50 and Other Pipeline Programs TAMPA, Fla. & CAMBRIDGE, Mass. - (BUSINESS WIRE) - Elpida Therapeutics, a non-profit biotechnology company developing gene therapies for ultra-rare diseases, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced a strategic partnership to support late-phase manufacturing of Elpida's lead program, an AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50). Under the agreement, Catalent will also be granted exclusive manufacturing rights to Elpida's other pipeline adeno-associated virus (AAV) gene therapy programs. SPG50 is an ultra-rare neurodegenerative disorder caused by AP4M1 mutations, beginning in infancy. Untreated, the disorder leads to cognitive impairment, epilepsy and progressive paralysis by early adulthood. "This collaboration with Catalent represents a critical step in ensuring continued patient access to our SPG50 gene therapy program. Without this support, the final patient planned for treatment by the end of this year could have marked the end of this therapy's availability," said Terry Pirovolakis, Founder and Chief Executive Officer, Elpida Therapeutics. "Together, we are building a path to reach all patients living with SPG50 and, ultimately, other devastating ultra-rare diseases." "This partnership reflects Catalent's commitment to applying our broad gene therapy manufacturing expertise and Patient First approach to programs with significant unmet need," said David McErlane, Biologics Group President for Catalent. "By leveraging our broad expertise in end-to-end AAV capabilities, we look forward to supporting Elpida's SPG50 program through late-phase manufacturing so it can advance toward regulatory submission." Catalent will utilize its industry-leading UpTempo(TM) AAV manufacturing platform, incorporating its proprietary HEK293 cell line, pre-validated off-the-shelf AAV plasmids, and pre-qualified analytical assays, to accelerate the production of R&D and GMP-grade material required for SPG50 process validation and to assist Elpida with its Biologics License Application submission. Catalent has partnered with clients on over 80 gene therapy programs, including four commercial programs to date, from early development through all clinical stages and commercialization. About Catalent. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer-health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com. About Elpida Therapeutics. Elpida Therapeutics' mission aims to address the current and significant unmet medical needs of patients with ultra-rare diseases. By leveraging scientific advancements and the now well-established safety and understanding of certain gene therapies, Elpida - a non-profit - aims to put cures within reach of families and children who desperately need them. Elpida's business model focuses on partnerships that promote efficiency and the chance to treat a greater number of patients while being self-sustaining and replicable. The company advances programs that traditional biotech companies find difficult to bring to completion, including those deprioritized or lacking investment due to small patient populations but supported by strong scientific data. For more information, visit www.Elpidatx.com. Contacts. (Contact details were not provided in the source text.) Want to join the conversation?