Catalent

The development and manufacturing of innovative drug products, particularly those involving protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant hurdles. A primary challenge lies in designing scalable manufacturing processes that meet production demands while ensuring stability and bioavailability. Traditional methods often fall short when handling advanced therapeutic modalities, resulting in limitations in production volume, product consistency, and manufacturability. Addressing these limitations is critical to bringing novel therapies to market effectively and at scale. Spray drying has emerged as a scalable and consistent manufacturing process for producing drug product intermediates. This paper explores the use of spray drying to overcome manufacturing bottlenecks and enhance development across a wide range of drug products.

Catalent’s micronization services help innovators overcome the toughest drug development challenges. Our high-containment facilities and expert scientists deliver consistent particle size reduction, high API recovery, and audit-ready processes to support early-phase clinical programs. Whether your project requires potent API handling, rapid turnaround, or extended analytical verification, Catalent combines speed, precision, and compliance to keep your milestones on track. Gain insights into real-world case studies that demonstrate how our structured, transparent approach ensures reliable delivery while protecting your valuable APIs. Discover why leading pharmaceutical and biotech companies choose Catalent as their trusted CDMO partner for micronization.

Pharmaceutical micronization, the process of reducing particle size to the micrometer scale, has become a critical technology for improving drug solubility, bioavailability, and formulation flexibility. Catalent, a global leader in drug development and delivery solutions, offers world-class micronization services through its specialized facilities in Dartford, UK, and Malvern, Pennsylvania, USA, supported by a network of forward processing commercial-scale manufacturing sites. This article explores the advantages of micronization and how Catalent’s integrated approach accelerates drug development.

Modern drug development faces a two-part pressure test: molecules are getting harder to formulate, and global manufacturing routes are getting harder to rely on. Poor water solubility and limited physical stability continue to delay many small-molecule and peptide programs, while shifting trade policies, logistics constraints, and onshoring pressure increase the cost and risk of fragmented supply chains. Sponsors need formulation strategies that improve performance and also translate cleanly to robust, predictable manufacturing. This paper explores how integrating large-scale domestic spray drying capacity earlier in development can accelerate timelines, lower costs, and strengthen portfolio resilience in an unpredictable global landscape. It outlines how this approach supports rapid development, enhances cost efficiency for high-volume therapies, and mitigates risks tied to international manufacturing disruptions.

Sequence variant analysis is essential for characterizing biotherapeutic proteins, but high rates of false positives can slow development. Subtle yet potentially profound changes to a protein's amino acid sequence can dramatically alter its function and impact patient safety. This paper reveals how low-level posttranslational modifications introduced during protein digestion can be misidentified as sequence variants. By implementing time-course digestion during method development, it can effectively distinguish true variants from artifacts, significantly reducing data analysis time. Case studies also show how to integrate time-course digestion into a workflow.

Liquid nasal drug delivery has evolved from simple local therapies into a highly versatile platform supporting rapid systemic delivery, emergency rescue medications, and emerging CNS-targeted treatments. As these applications expand, successful development increasingly depends on early, integrated alignment of formulation science, device selection, analytical control, and manufacturing strategy. In this article, Catalent experts Dr. Alan Watts and David Wilcox examine the current and emerging nasal delivery landscape and outline critical chemistry, manufacturing, and controls (CMC) considerations across development, scale-up, and commercial production. Drawing on real-world experience, the piece highlights practical strategies to reduce technical risk, support regulatory readiness, and enable robust, scalable liquid nasal drug products.

Webinar Date/Time: Tue, Jun 9, 2026 11:00 AM EDT

The development of biologics, from initial molecule selection to commercial product, presents complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing, regulatory delays, or even project termination. Download this article to learn more about how a structured, data-driven developability workflow can de-risk biologics during early stages of development.

This scientific poster showcases how GPEx® Lightning enables precise, digital control of gene expression for complex biologics. By leveraging targeted integration into ~200 Dock sites and a single optimized construct, developers can fine-tune gene ratios for co-expression of enzymes, cofactors, and multi-chain proteins. Learn how this approach streamlines screening, boosts titers, and shortens timelines—even for products with unknown stoichiometry.

This whitepaper explores biocapacitance measurement as a process analytical technology (PAT) for real-time biomass monitoring in mammalian and microbial systems. Learn how this QbD-aligned approach enhances upstream process control, reduces reliance on post-batch testing, and supports continuous manufacturing. Three real-world applications illustrate its impact on process visibility and efficiency.

Discover how Catalent’s GPEx® Lightning platform revolutionizes cell line development for complex biologics. This executive summary highlights how the platform enables rapid, high-titer expression of multispecific antibodies and other challenging proteins—accelerating timelines, improving production efficiency, and supporting commercial-scale manufacturing. Learn how tunable expression and digital control empower your team to overcome development bottlenecks and drive innovation in next-generation biologics.

Catalent’s GPEx® Lightning platform delivers stable, high-yield cell lines with unmatched speed—achieving titers up to 15g/L for mAbs and 11g/L for bispecifics. With 25-day pool generation and up to 12 weeks saved on development timelines, this offering sheet outlines key performance metrics and benefits that make GPEx® Lightning a game-changer for biologics developers.

Webinar Date/Time: Tue, Dec 9, 2025 11:00 AM EST

Webinar Date/Time: Tue, Nov 18, 2025 11:00 AM EST

Nasal drug delivery has been around since the 1950s when it was used for over-the-counter (OTC) decongestants. In the current pharmaceutical industry, it is used across biologics, small, and large molecule applications, and even has potential for neurodegenerative diseases like Alzheimer’s because it can pass the blood-brain barrier and first-pass metabolism.

Pharmaceutical micronization plays a pivotal role in enhancing the efficacy and bioavailability of many active pharmaceutical ingredients and the need for robust, repeatable and precise particle size control is critical. This article provides an in-depth review of milling equipment, including jet, pin, hammer, conical and cryogenic mills. Each technique is influenced by material properties like hardness/brittleness, morphology, and moisture content, as well as milling parameters such as feed rate, grinding pressure, mill speed and temperature. By selecting the right milling equipment and optimizing its operation, pharmaceutical innovators can ensure that their products meet the highest standards of quality, efficacy, and safety.

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes. Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.

David McErlane, Group President of Biologics at Catalent, shares how integrated expertise in biologics helps simplify complexity, accelerate development, and deliver therapies to patients faster.

Webinar Date/Time: Thu, Oct 16, 2025 11:00 AM EDT

Webinar Date/Time: Tue, Sep 23, 2025 11:00 AM EDT

Discover how pharmacy-led models in direct-to-patient clinical supply are pivotal in modernizing clinical trials, offering scalable, patient-centric solutions that align with regulatory guidance and industry trends. Strategic collaboration with pharmacy providers is the key to unlocking the full potential and benefits of decentralized clinical trials (DCTs).

Global decentralized trials require fast, efficient, and sustainable clinical supply solutions. This case study shows how a biopharma company worked with Catalent’s FastChain® demand-led model to improve supply by reducing waste and shipments by 40%, speeding patient dosing to under three weeks, and enabling flexible, decentralized packaging and distribution, whilst supporting an eco-friendly trial management worldwide.