Catalent

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.

This eBook includes an overview of outsourcing trends in the oral solid dose market. Featured articles describe the robust market resulting from the demand for specialized dosage forms such as controlled release, pediatric and geriatric delivery vehicles.

The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this executive summary, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this executive summary includes an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.

Catalent's Martin De Brauwere and Maria Lopez react to cell therapy innovations and highlight strategies to optimize the drug development and manufacturing process with assistance from a CDMO.

Webinar Date/Time: Thursday, August 24th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Webinar Date/Time: Tue, Aug 8, 2023 11:00 AM EDT

This infographic highlights variables for supply chain oversight and management for cell and gene therapies, which should be considered early - before the finished therapy is ready for patient administration.

Webinar Date/Time: Thu, Jul 20, 2023 11:00 AM EDT

Webinar Date/Time: Tuesday June 13, 2023 at 11 am EDT | 4pm BST | 5pm CEST

For studies involving products such as biologics and biosimilars, maintaining reliability of clinical supply can be challenging. Explore how different cold chain strategies can be leveraged to maintain product integrity in transit and minimize disruptions to clinical supply.

This eBook outlines how a CDMO specializing in advanced modalities can help sponsors to create a reliable and streamlined autologous cell therapy supply chain that maintains product quality, integrity, and compliance.

In this executive summary, learn how taking a parallel & integrated approach to drug substance development, drug product manufacturing, & clinical supply can significantly shorten the time from development to clinic for a biologic drug.

This white paper details the challenges to optimizing the emerging supply chain, from manufacture through clinical trials to market, and how they may be overcome.

Catalent offers end-to-end solutions to accelerate drug development and market entry, with specialization in handling highly potent, hormonal, and cytotoxic compounds, integrating comprehensive risk assessment and controls for management and containment.

Webinar Date/Time: Tue, Apr 25, 2023 11:00 AM EDT

A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success.

Advances in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterised using multiple material sparing assays, allowing the most promising formulation candidates to move on to in vivo studies.

Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound is processed in the body and improve the fate of many of these candidates, improving pharmacokinetic profiles and pharmacodynamic responses. Two Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner.

API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

Developers anxious to move their small molecule to Phase I may not have the time or resources to fully characterize the druggability of their candidate. Issues that could delay or even derail the program may appear in later clinical studies. Catalent has the resources to characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond.