Catalent

Articles by Catalent

Roles and Responsibilities of Specialized Clinical Supply Experts

ByCatalent

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.

Critical Supply Strategies for CROs

ByCatalent

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client. Additionally, once the CRO has been awarded the project and now must create an executable plan for managing the study’s complex clinical supply needs, there are one or more key decision influencers who are critical to engage early on during the planning and project set-up stage and several proactive steps to take to build a solid clinical supply plan.

Commercial Drug Sourcing for Clinical Trial

ByCatalent

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

Strategies for Successful Manufacturing of Highly Potent Oral Solids

ByCatalent

Oral drug products that contain highly potent active pharmaceutical ingredients (HPAPIs) continue to be a driving force in the global pharmaceutical market. In this Q&A article, industry experts discuss some of the challenges in HPAPI drug product manufacturing and the key issues sponsors should consider when partnering with a contract development and manufacturing organization (CDMO).

Developing & Manufacturing Drugs with HPAPIs

ByCatalent

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility. This article discusses how to effectively classify highly potent APIs (HPAPIs), and to help develop containment protocols and manufacturing processes that are both safe and efficient.

Advancing Lipid-Based Formulations and Softgels in Drug Development (Feb 2024)

ByCatalent

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.

Innovative Softgel Technologies to Deliver Poorly Soluble Molecules (Nov 2023)

ByCatalent

In this eBook learn more on how to expedite the development pathway for early phase compounds, and how lipid based formulations provide innovative approach to enhance bioavailability for challenging molecules. It also presents how the lipid-based delivery provides a tool for highly potent, poorly soluble, and unstable APIs.

Softgel Technology for Fast-Tracked Development Programs

ByCatalent

Download the article to learn how lipid-based formulation allows for the timely completion of early and late-phase development activities, and provides relatively straightforward scale-up dosage form manufacturing to meet the commercial volume demand requirements for newly launched products.

Exploring Pectin and the Advancement of Delayed Release Technology

ByCatalent

In this webinar, experts will provide an overview of why the properties and structure of pectin are well suited for site-specific delivery to the colon. In addition, experts will also provide insights into how softgel capsules, formed by the combination of both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications.

White Paper - Formulation and Evaluation of Enteric Coated Aspirin Capsules

ByCatalent

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the active pharmaceutical ingredient (API) from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location. By selecting enteric coatings, formulators can ensure the protection of their acid-sensitive APIs and create a controlled release drug delivery system. With the latest polymer coatings technology, there's no limit to the precision and adaptability that can be achieved in drug formulations. This white paper provides valuable insights into the successful application of enteric polymer coatings for controlled drug delivery systems. Discover how this innovative technology can transform your oral drug formulations.