Catalent

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.

In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with orphan drugs will be included, with insights on how drug sponsors of all sizes work with contract development and manufacturing organizations (CDMOs) to achieve their goals.

The development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines have poor aqueous solubility and bioavailability.

Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules. For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities. However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development. If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted. Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.

Webinar Date/Time: Tue, Apr 18, 2023 11:00 AM EDT

Webinar Date/Time: Tue, Apr 4, 2023 11:00 AM EDT

Webinar Date/Time: Thu, Mar 30, 2023 11:00 AM EDT

Catalent’s recent completion of a $30 million (€27 million) project at its facility in Limoges, France, transformed the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services, and packaging. The site further expand Catalent Biologics’ global network, with early phase integrated clinical development through to clinical supply services and small-scale commercial manufacturing, allowing seamless tech transfer of projects as they progress to late-stage and larger-scale commercial supply from other Catalent manufacturing facilities in Europe and North America.

Webinar Date/Time: Thu, Mar 23, 2023 11:00 AM EDT

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.