Catalent Pharma Solutions
and
Aptuit
announced an agreement for Catalent to acquire the Clinical Trial Supplies business of Aptuit LLC for cash consideration of $410 million on a cash and debt free basis. The acquisition will substantially expand Catalent’s Development & Clinical Services business, transforming it into the #2 provider globally in clinical supply solutions, and adding important development and clinical manufacturing expertise and capacity. Following the close of the transaction, Aptuit will focus on its market-leading integrated discovery to mid-phase development business.
“This transaction builds important expertise, scale and capability for our Development & Clinical Services business to better meet our customers’ needs globally,” said John Chiminski, President and CEO of Catalent. “This transaction also strengthens Catalent’s global leadership in development solutions and advanced delivery technologies for drugs and biologics.”
Catalent’s Development & Clinical Services business offers clinical supply services, analytical chemistry, respiratory product development, regulatory consulting, and biologics cell line development. Catalent has made substantial recent investments to extend the capabilities and capacity of the business. Catalent today provides the broadest range of expert development services, which can drive more efficient development timelines, and help customers bring more compounds and better products to market faster.
Aptuit’s remaining business maintains state-of-the-art discovery, development and manufacturing facilities in the United States, Europe and Asia. Aptuit offers the most complete set of integrated early development capabilities in the industry including discovery, early development, solid state chemistry, sterile fill parenterals, high potency APIs through Class V and formulation development. Aptuit is dedicated to supporting the global biotech and pharmaceutical industry by accelerating timelines, maintaining quality and reducing the cost of bringing drugs to market.
The completion of the transaction is subject to customary closing conditions including approval from regulatory authorities, and is expected to occur by the end of the calendar year. Other terms of the transaction were not disclosed.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.