Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.
Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics
By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.
Webinar Date/Time: Wed, Oct 16, 2024 11:00 AM EDT
Webinar Date/Time: Tue, Sep 24, 2024 11:00 AM EDT
Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits. Learn more about:
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.
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.
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.
Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays.
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 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.
Catalent’s approach to containment mitigates cross-contamination risk and regulatory issues, ultimately safeguarding patients. Download this article written by Karolina Narczykiewicz, an EHS expert at Catalent Pharma.
Webinar Date/Time: Tue, Apr 16, 2024 11:00 AM EDT
Webinar Date/Time: Thu, Apr 25, 2024 11:00 AM EDT
Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT
Webinar Date/Time: Wed, Apr 24, 2024 11:00 AM EDT
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.
Webinar Date/Time: Thu, Mar 7, 2024 10:00 AM EST
Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST
Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST
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.
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.
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.
Webinar Date/Time: Thursday, Nov 30, 2023 at 11:00 AM EST
Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. Learn more about creating a safe, efficient and scalable drug development program with HPAPIs in this eBook.
Webinar Date/Time: Tuesday, October 17, 2023 at 11am EDT | 4pm BST | 5pm CEST
Webinar Date/Time: Thursday, October 12, 2023 at 11am EDT | 4pm BST | 5pm CEST
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.
New drugs receiving expedited approval have shorter timelines, which can create unique challenges for development and manufacturing. Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process. Download the executive summary to get expert insights on overcoming manufacturing challenges associated with expedited development programs.
