Whitepapers

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.

Understanding the role of secondary packaging as a first line of defense is a key component in the war on counterfeit drugs.

In this white paper, we zoom out with a broader lens to view serialization as part of a broader system to ensure safety in pharmaceuticals.

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet 3D-printing enables advanced process analytics, tablet-level traceability, and continuous monitoring to provide a data-driven approach to pharmaceutical production. By measuring critical quality attributes for every tablet throughout manufacturing, the platform enables continuous process verification, targeted identification of deviations, and reduced waste compared with traditional batch-based quality methods. This integrated foundation supports real-time release while delivering greater transparency, process control, and operational efficiency across the product lifecycle.

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.

Discover the benefits of a global CDMO manufacturing strategy built for scale, speed and reliability

See how early supply chain engagement and continuous improvement reduce risk, accelerate tech transfer and time-to-market, and ensure reliable supply for customers and patients—download the white paper to learn more.

Biologics manufacturing is shifting toward integrated ecosystems that align clinical and commercial needs within a unified operational model. Learn how to deliver speed, flexibility, and lifecycle efficiency from early clinical supply to high-volume commercial production.

MaxiPure® Polysorbate 80 is a highly pure excipient designed for high-value injectable applications where control of particles, oxidative stress, and biological compatibility is essential. Fully compliant with Ph. Eur., USP-NF, JP and CP monographs, this non-ionic surfactant is characterized by an oleic acid content above 98%, exceptionally low impurity levels, and outstanding clarity. By combining regulatory excellence with functional performance, MaxiPure® Polysorbate 80 supports the development of stable and safe protein-based therapeutics, and ensures formulation reliability across the drug development lifecycle.

Scaling up a lyophilization process is one of the most technically demanding challenges in biomanufacturing, and even the smallest mistakes can lead to failed batches, delays, and extra costs. This white paper from Jubilant HollisterStier (JHS) shows how choosing the right partner can reduce risk, guarantee quality, and accelerate timelines and features a real-world case study of how JHS lead a successful Phase 3 oncology drug scale-up.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

The manufacturing landscape is evolving rapidly, marked by ever-increasing competition and consumer demands, unpredictable supply chain disruptions, and the persistent challenge of employee turnover. Optimizing processes and tightening production efficiency has become a top priority for manufacturers across the process industries. Among these processes, efficient mixing stands out as a cornerstone of production, affecting energy consumption, product quality, and operational costs. Yet despite its pivotal role, the benefits of mixing are often underestimated. This article presents five possible strategies that manufacturers can begin to adopt.

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

This white paper provides actionable insights into FDA expectations, industry best practices, and free tools to mitigate the risk of FDA Observations

Discover the four major hidden cost centers teams tend to overlook when it comes to paper logbooks, along with a real world example showing what happens when a site replaces paper with digital