Catalent

Podcasts

One of the challenges facing gene therapy manufacturing is the lack of standardization in the process. Standardized methods, materials, analytics, and documentation can help reduce supply chain bottlenecks, increase efficiencies and lead to accelerated development timelines and smoother regulatory filings.  In this podcast, we will discuss how Catalent is working to simplify the supply chain, develop processes scalable for late-stage and commercial needs, and accelerate timelines for production of clinical materials

Platform Processes for Streamlined Regulatory Filing and Decreased Time to Market for Gene Therapies

Medication non-compliance by patients has a significant impact on the burden of healthcare costs. The common challenges causing patient non-compliance are due to a combination of influences, including specific disease type, age, and therapy regimen. Often, the regimen may include dosage forms that are not sufficiently tailored to meet patient needs. As a result of poor medication adherence, overall treatment success lessens. To mitigate the risk of patient non-compliance, innovators should consider specific patient challenges for different disease types and the many variables in the lives of patients. In this webinar, experts provide an overview of the needs of different patient populations, and examine the common challenges leading to non-compliance. The experts also discuss how an orally dissolving tablet (ODT) provides a solution to address patient challenges and enables potentially more successful treatments.

Overview of different patient populations and common challenges

Learn what influences medication adherence and the impacts of non-compliance

Discover how Zydis® ODT can facilitate medication adherence and help create more successful treatments


Principal Consultant
David P Elder Consultancy


David Elder has nearly 40 years of service within the pharmaceutical industry at Sterling, Syntext and GlaxoSmithKline. He is now an independent GMC consultant. He is a visiting professor at King’s College, London and is a member of the British Pharmacopoeia. He is a member of the Joint Pharmaceutical Analysis Group (JPAG) and the Analytical Division Council of the Royal Society of Chemistry.


Head of Zydis Product Development
Catalent

Ralph Gosden, Head of Product Development at Catalent’s Swindon, UK site oversees Catalent’s Zydis® Fast Dissolve Tablet scale up and strategic project capabilities. In a career spanning over 20 years, Ralph has worked in all the major disciplines in pharmaceutical R&D from feasibility through scale up and validation and has extensive experience understanding formulation and process development for oral dose forms.

Webcasts

Thursday, January 27th 2022 at 11AM EST | 4PM GMT | 8AM PST
In this webinar, experts provide an overview of the needs of different patient populations, and examine the common challenges leading to non-compliance. The experts also discuss how an orally dissolving tablet (ODT) provides a solution to address patient challenges and enables potentially more successful treatments. 

Dosage Form Design & Patient Compliance: Exploring ODTs as a Patient-centric Solution

Videos

Is My Molecule Suitable for an Orally Disintegrating Tablet 

Catalent’s OptiDose Design Solution integrates pharmaceutics, critical CMC and DMPK parameters, and dose form design target patient characteristics to create differentiated treatments that are successful for innovators, patients and healthcare professionals.

The methodology uses a design approach that combines data-driven scientific tools with Catalent’s extensive development expertise. Patient needs and market realities are considered upfront in the process, to guide development decisions and ensure a product with the optimal combination of patient acceptance and adherence, as well as differentiation from existing standards of care.

By taking an agnostic evaluation of a molecule against potential dose form technologies, products can be designed using Catalent’s portfolio of advanced softgel solutions, including OptiShell capsules that can improve bioavailability for poorly water-soluble and poorly permeable compounds, and offer modified or extended release profiles.

Catalent’s industry-leading broad technology toolkit also includes Zydis orally dissolving tablets, and FlexDoseSM stick pack solutions to optimise a molecule’s potential.

Catalent
14 Schoolhouse Road Somerset, NJ 08873 USA
Telephone: +1 888 765 8846 (US) ; 00800 88 55 6178 (EU/ROW)


Articles

OptiDose Design Solution

Transforming IMP into Clinical Supply: An Integrated Approach

With more than 30 years of experience in supporting the development of inhaled products, and full commercial-scale manufacturing capabilities for dry powder inhalers, metered dose inhalers and unit/bi-dose nasal sprays, Catalent offers complete, end-to-end solutions for today’s inhalation dose forms.

Catalent provides formulation feasibility, device selection and clinical supply services, through to commercial filling and packaging, as well as analytical testing, final product characterization and release testing to ensure accurate, consistent drug delivery. 

https://www.catalent.com/specialty/inhalation/


14 Schoolhouse Road Somerset, NJ 08873 USA
Tel. +1.888.765.8846
solutions@catalent.com


With more than 30 years’ experience, Catalent offers end-to-end solutions for multiple inhalation dose forms.