Catalent

Conventional manufacturing of dosage forms for small molecule drugs in centralized facilities is not well-suited to meet the needs of adaptive clinical trials for early-phase dose escalation and confirmatory trials. Current approaches for developing finished dosage forms for adaptive Phase I trials are limited to simple formulations, owing to the limited understanding of drug products and manufacturing processes in early development. While the centralized approach may be suitable for water-soluble compounds, it may not address issues of challenging molecules, which would need to be overcome using advanced drug delivery technologies.
In this webinar, experts from Catalent and HMR will discuss a unique approach that integrates advanced formulation expertise with on-demand Phase I clinical manufacturing, adaptive clinical testing, and regulatory support, to help achieve flexible and efficient first-in-human studies and fast development of challenging molecules.
Participants will discover how a strategic partnership between a contract and development manufacturing organization (CDMO) and contract research organization (CRO) can play a significant role in accelerating clinical trial supply manufacturing in support of an adaptive trial design and reduce clinical development timelines and costs while increasing success rates.



Identify clinical operational challenges during the adaptive dose-ranging study, and their impact on trial drug supplies

Learn how the manufacturing of formulations and dosage forms “on-demand” can accommodate an adaptive dosing protocol

Discover how a strategic collaboration between a CDMO and CRO can create a streamlined process between clinical operation and drug supply, which benefits both patients and innovator companies.

Chemistry, manufacturing, and controls (CMC)


Director, Science and Technology
Catalent


 plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years of experience at Catalent where he has held roles of increasing responsibility and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in chemistry and analytical science from Loughborough University, Loughborough, U.K.




Director of Clinical Science and Regulatory Affairs
Hammersmith Medicines Research

 has over 15 years of experience in early phase clinical pharmacology studies, having first joined Hammersmith Medicines Research (HMR) as a clinical project manager in 2006. In 2021, she became head of HMR’s projects division, with responsibility for clinical project management, medical writing, and regulatory support. Dowen has worked on over 300 early phase clinical studies, including adaptive design, first-in-human, PET, bridging, bioequivalence, drug-drug interaction, and studies involving the administration of vaccines, GMOs, psychedelics, or radioactive compounds. In 2010, she earned a certificate in human pharmacology from the Royal College of Physicians, Faculty of Pharmaceutical Medicine, London, U.K. Prior to joining HMR, she held post-doctoral research associate positions at both Cambridge University and Cancer Research U.K. She is a member of the Health Research Authority Phase 1 Advisory Group.
Dowen holds a master’s in natural sciences and a doctorate in molecular oncology, both from Cambridge University, Cambridge, U.K.


Webcasts

Tuesday, October 11, 2022 at 11am EDT | 10am CDT | 8am PDT

Learn how integrated formulation and clinical manufacturing expertise, as well as strategic partnerships between CDMOs and CROs, can help achieve flexible and efficient first-in-human studies, fast development of challenging molecules, and reduced clinical development timelines and costs, all while increasing success rates.

Successful Phase 1 Adaptive Trials: Through the Lens of Clinical Operations, Formulation Development, and Regulatory Compliance

Articles

Navigating Obstacles and Creating Opportunities for Orphan Biologics

Due to their small batch size, infrequent or inconsistent manufacturing, and packaging of low-volume drugs, can create supply challenges, and lead to market shortages and adverse health consequences for patients who rely on their medications. This is a particular challenge for niche and orphan drugs, and is especially serious as there may be no alternative treatments available.

In these circumstances, a clinical supply provider can be a viable alternative to high-volume packagers and large-scale CDMOs. Accustomed to working with smaller quantities, a clinical supply provider with serialisation capabilities is ideally suited to support the commercial packaging and distribution of low-volume products.

Catalent’s global network of oral, biologic and cell/gene therapy facilities have the necessary packaging, serialisation, manufacturing and storage capabilities and capacity for the efficient and flexible commercial supply of orphan, niche and low-volume drugs. Catalent’s packaging experts provide agile and strategic solutions to meet the everyday needs of smaller patient populations, and are highly experienced in supply chain logistics and balancing supply with demand.

https://www.clinical.catalent.com/expert-content/expanded-access-and-commercial-packaging-strategies-for-orphan-niche-and-low-volume-drugs-2/?source=7013b000001Jczy&utm_medium=Display-Direct&utm_campaign=FY22-CSS-Display-Direct-PTE-Jun22&utm_content=

Catalent’s global network of manufacturing and packaging facilities provide the capacity for efficient commercial supply of orphan, niche and low-volume drugs, which require agile, flexible and strategic solutions.

Catalent's Low-volume Commercial Packaging

Catalent has over 85 years’ manufacturing expertise, and a global network of more than 40 facilities that provide flexible commercial and clinical manufacturing solutions.

Producing over 70 billion doses and supporting 150 product launches annually, Catalent offers manufacturing excellence in oral, sterile, biologic and inhaled dose forms for clients, and has proven expertise in technology transfers, product launches, custom suite models, specialty handling (highly potent / DEA licensed compounds), and manufacturing technologies.

Catalent’s flexible global manufacturing network supports products throughout their lifecycle, from clinical to commercial supply.

Flexible Manufacturing Solutions

Spray drying offers multiple opportunities for improving the formulation of both poorly soluble compounds and inhaled drug products. Although spray drying is a well-established manufacturing process, challenges persist throughout the development process and novel applications are continuously evaluated. Join this webinar to hear from a panel of experts on the critical challenges of spray dried powder formulation development, risk mitigation strategies and the effect of material and process parameters on the physical and chemical properties of the spray dried powder of pharmaceutical products.

Understand key challenges during spray dried powder development

Gain insight into risk mitigation strategies used to address common challenges from the early to late phase of spray dried amorphous and crystalline powder development

Understand the impact of spray drying on powder properties in terms of manufacturability and downstream processability

This webinar will appeal to individuals working in:


Director of Scientific Services
Catalent


Matt Ling is Director of Scientific Services and a member of the site leadership team at Catalent, Nottingham, U.K. He has over 20 years of experience in the pharmaceutical industry, mostly working in large pharmaceutical companies, with roles in analytical, formulation development, advanced drug delivery and project leadership spanning all phases of discovery and development. Ling has a keen interest in the application of drug delivery technologies and holds a doctorate in Organic Chemistry from the University of Nottingham, Nottingham, U.K.


Thomas Lund is a Senior Scientist at Catalent’s Early Development Center of Excellence in San Diego. In his role, he provides technical oversight for spray drying projects from preclinical through GMP stages, as well as supports spray drying technical transfers to other sites within the global Catalent network. Lund has significant expertise with particle engineering via spray drying and broad experience in formulation and process development for the manufacture of solid oral dosage forms. Lund holds a Bachelor’s in Chemical Engineering from Montana State University, Bozeman, Montana.


Senior Scientist
Research Center Pharmaceutical Engineering GmbH


Carolina Corzo is a Chemical Engineer with a doctorate in Pharmaceutical Technology from Karl-Franzens University of Graz, Austria. Currently, she is a Senior Scientist at the Research Center of Pharmaceutical Engineering working in the field of Advanced Products and Delivery. In her role as a scientific project leader, she oversees ongoing activities related to lipid-based formulations, particle engineering, and lab-scale spray-drying for oral and inhalation products. Additionally, she provides scientific support to industrial partners on pre-formulation, formulation, solid state and stability characterization for drug product development. Corzo is an expert on the material science of lipid-based excipients (LBE) and their correlation to process and product performance. Her doctoral dissertation focused on the mechanistic assessment of LBE processed through spray-drying on the development of lipid-microparticles for inhalation.

Thursday, April 21, 2022 at 11am ET | 4pm GMT | 5pm CET
This webinar will discuss risk mitigation strategies used to address common challenges during spray dried powder development and give insight into the impact of spray drying on powder properties in terms of manufacturability and downstream processability.



Advanced Troubleshooting for Spray Drying of Pharmaceuticals

Podcasts

Biopharma 4.0 is fundamentally changing the way that manufacturers do business. It will enable better products produced faster, with consistent high quality at a reduced cost. The process of moving from silos of automated or semi-automated processes (Biopharma 3.0) to a fully connected enterprise comprised of smart things is a journey that many manufacturers are only just beginning. Tune in to learn more on the latest status and impact that Biopharma 4.0 has on biopharmaceutical manufacturing.   