Logo Image

Catalent

Articles by Catalent

The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success

ByCatalent

Sponsored Content

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time

ByCatalent

Sponsored Content

The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.

Roles and Responsibilities of Specialized Clinical Supply Experts

ByCatalent

Sponsored Content

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

Sponsored Content

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

Sponsored Content

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

Sponsored Content

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

Sponsored Content

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.