Catalent

- Current state of the cellular therapy market and challenges bringing newer therapies to commercialization

- Critical components tied to successful drug development and manufacturing of cell therapies

- Remaining current with regulatory guidance tied to cell therapies

- Proper oversight of supply chains tied to a cell therapy project

Videos

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.

Solutions to Optimize Cell Therapy Development and Manufacturing

In this Drug Digest video, our speakers will discuss aseptic processing and the manufacturing portion of the process. Join the Drug Digest video to help prepare for manufacturing and barriers that arise in the aseptic process. Learn how open and closed isolators, surface decontamination, and automated aseptic processing relate to conventional aseptic procedures.

https://www.pharmtech.com/pt_w/improving-aseptic

Aseptic processing is important to almost every step of the manufacturing process for pharmaceuticals, like formulation, filling, and inspection (1). According to recent research, this market is expected to be valued at $83 million (USD) and to increase approximately 6.7% in the next ten years (2).

With more growth comes more challenges, and these industry practices need to be refined for the best execution with each pharmaceutical created.

In this Drug Digest video, Dan Strange, TBD, and Richard Denk, TBD will provide expert insights about aseptic processing and manufacturing, including barriers to automated aseptic processing, what the future holds for this area, indirect product contact parts, and open and closed isolators.


Ascendia Pharma. Aseptic pharmaceutical manufacturing: how it works. November 17, 2021. https://ascendiapharma.com/newsroom/2021/11/17/aseptic-pharmaceutical-manufacturing

Future Market Insights. Aseptic processing market. April 2023. https://www.futuremarketinsights.com/reports/aseptic-processing-marke

The ability to identify barriers in automated aseptic processing and aseptic processing in general

The ability to learn about different moving parts in the process, like closed system, isolators, indirect product contact parts, and surface decontamination

Problem solving: ability to develop a plan for solving the biggest barriers in the clean room for a more efficient manufacturing process

Awareness: ability to successfully pinpoint new approaches to aseptic processing and how to respond as a laboratory personnel/manufacturer

Aseptic processing and sterilization experts

Webcasts

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


Improving Aseptic Processing and Manufacturing Needs

This webinar aims to address the specific needs of these sponsors by providing valuable insights and practical strategies. Experts will explore various aspects, including formulation considerations, safety protocols, regulatory compliance, and risk management associated with HPAPIs.

https://www.pharmtech.com/pt_w/highly-potent

The early development of highly potent active pharmaceutical ingredients (APIs) presents early-phase drug sponsors with unique and complex challenges. One of the primary hurdles in handling these APIs is their potential harm to humans and the environment, necessitating strict safety precautions throughout the development and manufacturing process. Furthermore, these APIs often exhibit poor solubility, instability, and poor bioavailability. To effectively address these issues, it is necessary to have facilities equipped with containment technologies to safeguard personnel and the environment. The formulation and manufacturing of highly potent APIs must also adhere to best practices that manage the risks associated with exposure during production while ensuring the API's efficacy and stability throughout formulation.

This webinar aims to address the specific needs of these sponsors by providing valuable insights and practical strategies. Experts will explore various aspects, including formulation considerations, safety protocols, regulatory compliance, and risk management associated with HPAPIs.



Understand the unique challenges posed by HPAPI in early drug development.

Learn about the importance of containment in protecting personnel and the environment during formulation development and manufacturing.

Gain insight into best practices for managing risks associated with handling and developing highly potent APIs.



Head of Pharmaceutical Development
Catalent


As Head of Pharmaceutical Development at Catalent’s facility in Greenville, North Carolina, 

 is responsible for overseeing all personnel, facilities and services related to formulation development, potent and cytotoxic products, fast-track development and clinical program support through to commercialization. In addition, Dr. Gold is responsible for implementing new technology platforms that include advanced drug delivery methods. He holds a doctorate in pharmaceutics/medicinal chemistry from the University of Kentucky, from where he also earned his master’s and bachelor’s degrees in chemistry.

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


Meeting the Needs of Early-Phase Drug Sponsors with Highly Potent Active Pharmaceutical Ingredients (HPAPIs) in the Pipeline

Articles

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.

Making the Case for Case Management for Cell and Gene Therapies

In this Drug Digest video, our speakers will discuss CDMOs and their ever-changing role in the biopharma space and current barriers in cell and gene therapy (CGT) manufacturing. Join the Drug Digest video to help prepare for manufacturing and cell/gene therapy challenges. Learn how digitalization, CDMOs, and CGT relate to conventional biopharma development and manufacturing.

https://www.pharmtech.com/pt_w/accelerating-biopharma

The biopharmaceutical industry has seen a lot of change in recent years, between new collaborations with supplier and contract development and manufacturing organizations (CDMOs) and accelerated drug delivery times. According to recent research, biopharmaceutical figures are already using digital and analytics for their benefit, with an increase of up to 40% in plant capacity, 20% in lead time, and 15% reduction in conversion costs (1).


With more growth comes more responsibilities, and processes like cell and gene therapy are on the forefront for the latest strategies to overcome the challenges in the manufacturing space.
In this Drug Digest video, Anil Kane, Global Head of Technical and Scientific Affairs, Pharma Services at Thermo Fisher Scientific, and Jason C. Foster, CEO and executive director at Ori Biotech, will provide expert insights into what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.

Reimagining the future of biopharma manufacturing

. October 11, 2022. https://www.mckinsey.com/industries/life-sciences/our-insights/reimagining-the-future-of-biopharma-manufacturing

The ability to identify the benefits of biopharma companies partnering with a CDMO

The ability to learn about different kinds of cell and gene therapies and how to overcome the barriers in the continuous manufacturing space

Problem solving: ability to develop a plan for concepts, such as scalability and being more cost efficient, with new products and techniques

Awareness: ability to successfully pinpoint new approaches to medicine and how to respond as a biopharma company


Global Head of Technical and Scientific Affairs
Pharma Services at Thermo Fisher Scientific

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


Accelerating Biopharma Development and Manufacturing through CDMOs and CGT

In this webinar, experts will offer insights into the perceived barriers to developing lipid-based formulation and recent advances in translating them in to useful clinical and commercial products of lipophilic drugs.

https://www.pharmtech.com/pt_w/toxicology

Lipid-based formulation (LBF) can potentially improve the oral bioavailability of challenging molecules. However, when planning for solubility and bioavailability enhancement of poorly soluble drugs, LBF is often overlooked due to a generally poor understanding of LBF technology and the prevalence of preconceived notions about its complexity, especially when transitioning formulations from preclinical toxicology to clinical studies.


In this webinar, experts will offer insights into the perceived barriers to developing LBFs and recent advances in translating them into useful clinical and commercial products of lipophilic drugs. Experts will also discuss lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile. In addition, the experts will discuss the preformulation considerations of LBF development and the use of PBPK modeling to yield key insights into oral bioavailability. Finally, experts will share approaches from an industrial standpoint on how to transition LBFs from preclinical toxicology to a viable formulation suitable for an accelerated pathway in the clinic.

Discuss how lipid-based formulations impart their solubility-enabling benefits.

Understand the opportunities and limitations of using lipid-based formulations in preclinical toxicological studies.

Explore key considerations when transitioning enhanced formulations into the clinic.


Professor
University of Copenhagen
Denmark

Dr. Anette Müllertz is professor at the University of Copenhagen, Denmark (UCPH). She is heading Bioneer:FARMA, a research-based, non-for-profit service provider within the area of pharmaceutical development. She did her PhD in chemical engineering at the Technical University of Denmark and thereafter worked 9 years for Novo Nordisk A/S. In 1998 she joined UCPH, where she is heading the Physiological Pharmaceutics Research Group, focusing on developing predictive biopharmaceutics tools for oral drug delivery and lipid-based drug delivery systems. She has 220 publications in international, peer-refereed journals (h-factor: 59 (Google Scholar 10/1-2021)).




CEO/President
Paracelsus, Inc.

Dr. Grace Furman received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University in Boston, MA (1992). She also holds a B.S. in toxicology (1986) and has been a Diplomate of the American Board of Toxicology since 2000. Dr. Furman is an active member of the American College of Toxicology (ACT) and has served ACT as a 2-term Council member (2009-2011 and 2017-2019), a member of the Nominating Committee (2008), as Secretary (2013-2014), and as co-chair (2017/2018) and chair (2018/2019) of the Education Committee. Dr. Furman is also an active member of the Society of Toxicology and the Southern California Chapter of the Society of Toxicology and has held several Executive Council positions, including President, within the Regional Chapter. Dr. Furman is chair emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego’s Women in Biosciences. Additionally, she designed and instructed the “Toxicology” classroom and distance-learning courses offered through University of California/San Diego Extension’s Drug Discovery and Development and AMDET Process Certificate Programs (2005-2014).




Senior Director, Scientific Advisory
Catalent

Lisa Caralli is Science and Technology Director, Pharmaceutics at Catalent San Diego. She has over 30 years of industry experience in pharmaceutical research and development. Lisa's area of expertise is analytical methods and formulation development of small molecules and peptides. In her role, she works with pharmaceutical companies to identify the right development pathway for their early development drug candidates and advances new technical offerings within Catalent.

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