Catalent

Articles

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.

Innovative Strategies to Maintain Product Integrity in Biologic and Biosimilar Clinical Studies

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.


Optimizing Cell Therapy Supply Chains for Success: Why Outsourcing Partner Expertise is Critical

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.

Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

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.

Bridging the Cell and Gene Therapy Gap Between Manufacture and the Supply Chain

Catalent is the leading partner for drug development, delivery and supply in the global pharmaceutical and biotechnology industries.

With its broad experience, technological and scientific expertise, and a history of more than 80 years in pharmaceutical delivery solutions, Catalent helps customers with a wide range of services, including API and particle size optimization, formulation development, as well as drug delivery technology and final dose form design. Partnering with innovators from the earliest stages of the drug development process and throughout a drug’s lifecycle, Catalent provides end-to-end solutions to accelerate programs to clinic and to market.

Catalent has more than 20 years of experience in highly potent product development and commercialization, and offers integrated analytical, manufacturing, clinical supply solutions, and global supply chain assurance. In that time, it has worked on more than 300 compounds with an occupational exposure limit of less than 10 µg/m3 at its network of 12 specialized facilities, which includes a state-of-the-art site in Greenville, N.C. with extensive potent drug handling capabilities.

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.

Catalent Potent Drug Handing Capabilities

In this webcast, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.

https://www.pharmtech.com/pt_w/commercial-manufacturing

Process characterization and validation is an important step in the product development journey and late-phase development. In some cases, process optimization is required for an existing manufacturing process before process characterization begins. Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. This presentation highlights the strategic plan Catalent executed to meet the needs of the program without sacrificing the thorough scientific evaluation of the process required for a successful validation campaign.

Details on the optimization process for both upstream and downstream manufacturing processes.

Catalent’s workflows for process characterization of the optimized process with examples.

A case study of how to strategically decrease the timeline from process optimization to commercial manufacturing.


Manager, Downstream Process Development
Catalent Biologics

manages a team of scientists in Catalent Madison’s Downstream Process Development Department. Her group is focused on the development of scalable biomanufacturing processes, tech transfer and late-stage process characterization.


Nicole obtained her B.S. in Biology from Hofstra University and her Ph.D. in Microbiology from MIT. She has worked at protein CDMOs for the duration of her professional career, spending 5 years at Aldevron before joining Catalent in October 2020. Her tenure at Catalent was initially focused on building the Downstream Process Characterization capabilities for the Madison site. Her role has since expanded to include early phase development and tech transfer to GMP.




Senior Scientist, Upstream Process Development
Catalent Biologics

 is a Senior Scientist in Upstream Process Development at the Catalent facility in Madison, WI, where he maintains a focus on late-phase projects, including those that were developed within Catalent from an early stage, as well as late-phase projects transferred to Catalent for clinical and commercial manufacturing. At Catalent, he leads efforts in process optimization and process characterization, while also supporting activities enabling GMP manufacturing, process performance qualification and continued process verification.
Daniel obtained his B.A. in Biology from the University of Minnesota – Twin Cities and his M.S. in Biotechnology from the University of Wisconsin – Madison. He has worked in the biopharmaceutical industry since 2016, focusing on upstream process development for biologics and cell therapies.

Webcasts

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