Catalent

Catalent has more than 25 years’ experience as a global leader in clinical supply services with flexible solutions for small molecules, biologics, and cell and gene therapies, including integrated services to accelerate products from early development to clinic.

Catalent offers customers a full range of services including clinical supply management, comprehensive packaging solutions, comparator sourcing, cold chain storage, and global distribution, as well as specialised supply chain services including FlexDirect

 direct-to-patient services and FastChain

With its eight GMP clinical packaging facilities, as well as two more opening soon, and over 50 strategically located global depots providing local and regional options for storage, distribution, and clinical returns management, Catalent has supported thousands of studies of all sizes and complexities in more than 80 countries.

To accommodate the need for greater flexibility in clinical trials, Catalent offers FlexDirect direct-to-patient supply solutions, enabling clinical supplies to be sent directly to patients’ homes. By reducing or eliminating the need for in-person clinical site visits and removing a key barrier for trial participation, sponsors can expand their geographic recruitment area, especially for rare diseases, potentially improving patient recruitment and retention.

To find out more about Catalent’s integrated services, visit 

Articles

Catalent is a global leader in clinical supply services with flexible solutions for small molecules, biologics, and cell and gene therapies, including integrated services to accelerate products to the clinic.

Integrated and Flexible Clinical Supply Solutions

Catalent’s OneXpress is a single, integrated solution that provides the fastest pathway from clinical development to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, the solution can help reduce a programme’s risk and increase chances of success by working in parallel to address potential roadblocks and ensure robust processes from clinic to launch.

Using Catalent’s integrated global network of facilities, and streamlined programme management, the OneXpress solution combines the expertise at Catalent’s early-phase drug development centres of excellence in Nottingham, U.K., Somerset, New Jersey, and San Diego in the U.S., with the proven track-record of Catalent’s oral solid dose commercial manufacturing facilities.

Overseen by a dedicated programme manager from start to finish, OneXpress combines phase-appropriate technologies and proven expertise, with scalable end-to-end capabilities throughout an extensive supply network, to achieve optimal accelerated manufacturing solutions at every stage.

Catalent’s OneXpress™ solution combines phase-appropriate scale and technologies with expertise across diverse dose forms to simplify development and accelerate a programme towards commercialisation.

OneXpress™ Solution for Accelerating Development to Commercialisation

Videos

GPEx Boost- The Next Generation of Cell Line Development

Podcasts

Zydis® - The versatile Orodispersable Tablet (ODT) Technology

There is often confusion about whether an 

) format would work for a drug of a particular weight, or for one with certain molecular characteristics or formulation requirements. ODTs are a versatile platform enabling quick and easy delivery of medications to patients; however, there remains considerable uncertainty about whether this dose form is an option for certain drugs and how the efficacy compares to that of standard tablets and capsules.

Patient, market, payor and regulatory considerations are key factors in determining whether an ODT is a suitable fit. Drug developers may consider an ODT format for New Chemical Entities (NCEs) to distinguish their brand or address challenging patient needs, or may look to an ODT format for established commercial products as part of a lifecycle management (LCM) project. This webinar aims to provide clarity on the types of molecules suitable for an ODT format as well as the regulatory pathways for new and established therapies.

A panel of four speakers will review the fundamentals of ODTs, including benefits, formats and development pathways, contrast with other oral dose forms, outline likely drug candidates and discuss Catalent’s proprietary ZYDIS® lyophilized ODT platform. The panel will further address the unique delivery routes associated with ODTs, including the potential for pre-gastric or gastrointestinal delivery and local activity at the oral mucosa, and review the physicochemical characteristics appropriate for each. ALK, a Danish pharmaceutical company focused on allergy treatments, will share how they leveraged ZYDIS® ODT technology to optimize their customer value proposition and create a commercially successful treatment for patients around the world.

Learn which doses, molecular weights and molecular characteristics are appropriate for ODT formats, and which can target gastrointestinal delivery, pre-gastric delivery or local oral mucosal activity

Understand the ODT format options and key advantages

Look at ways to differentiate an NCE, strengthen a brand and/or extend market share of an existing commercial product

Explore new technologies and directions for orally disintegrating tablets, including ZYDIS ULTRA® and ZYDIS® BIO.

Wednesday, May 5, 2021 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

Webcasts

*Wednesday, May 5, 2021 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST* What size API would work for an ODT targeting sublingual or enteric delivery?  Why would one consider an ODT over a tablet or capsule for standard G.I. absorption?  Learn more as Catalent discusses ODT technologies in this upcoming webinar. *On Demand Until May 5, 2022* 


Is My Molecule Suitable for an Orally Disintegrating Tablet?  

Catalent is the global leader in drug development and delivery and offers partners comprehensive solutions in development, dose design, and manufacturing. Its phase-appropriate technologies and expertise ensure that the right decisions are made at each stage of development, creating oral dose forms that can help improve a drug’s clinical efficacy and commercial success.

OptiDose Design Solution™ offers customers the combination of Catalent’s wide-ranging approach to drug development, coupled with the broadest selection of advanced drug delivery technologies and manufacturing platforms available.

Catalent’s OptiDose Design Solution provides comprehensive drug design assessment that considers a holistic review of the molecule, patient, and market considerations. By evaluating drug design considerations including developability, manufacturability, differentiation, and patient needs, Catalent’s scientific advisors provide options to inform dose form decisions that can help create a successful treatment for all stakeholders.

From its global network of facilities, Catalent offers accelerated early drug development, proven bioavailability enhancement solutions, advanced drug delivery technologies, and flexible manufacturing of a variety of oral dose forms, including RP Scherer

orally disintegrating tablets, modified-release capsules, and FlexDose

Catalent is the global leader in drug development and delivery, offering innovative development and manufacturing solutions for oral dosage forms.