Catalent

Articles

Accelerating Timeline by Planning for Clinical Supplies in Advance

	Scaling-up liquid formulations can present a number of challenges and headaches. This is especially true for complex solutions, suspensions and emulsions as well as biologics, sterile products, potent compounds and sensitive APIs. In this webcast, learn about potential formulation and filling issues when transitioning a liquid formulation from feasibility through commercialization.

	Product development experts share insights on a variety of formulation issues including mixing, solubility, microfluidization, viscosity, filtration and special API handling, with discussed solutions based on Catalent’s expertise in complex formulation. Equipment for liquid-filling and scale-up will be discussed with a focus on potential applications of advanced aseptic Blow-Fill-Seal (BFS) technology.

	Register early and submit your question for the Q&A discussion.

		How to manage challenges associated with typical liquid formulations, as well as unique issues for complex solutions, suspensions, and emulsions

		Special considerations for biologics, as well as potent or sensitive APIs

		Challenges when transitioning from small- to large-scale, and solutions made possible by Blow-Fill-Seal technology

Waiken Wong, PhD, Manager, Product Development Engineering, Catalent

	Wendy Khine, Director, Project Management, Catalent

Tuesday, Mar. 17, 2020 at 1pm EDT | 12pm CDT | 10am PDT

	On demand available after airing until Mar. 17, 2021

Webcasts

Complex liquids can be problematic for scale-up and manufacture.  Learn how the experts at Catalent have found solutions for the most challenging liquid formulations. 
Live: Tuesday, Mar. 17, 2020 at 1pm EDT | 12pm CDT | 10am PDT
On demand available after airing until Mar. 17, 2021 
Register free


Complex Liquid Formulations: Solutions for Scale-Up Challenges

http://www.pharmtech.com/pt_w/global_trials

	With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies and clinical supply support. Multiple factors, including positive changes in clinical research regulations, reduced costs to run trials, and large urban-centered populations are attracting sponsors to the region.

	Singapore has long been a gateway into the region for sponsors, offering well-established regulations and an excellent infrastructure. The city can serve as an ideal hub for the import and export of clinical supplies into and throughout the APAC region.

	Register for this webcast to get expert insights on using Singapore as a clinical supply hub.

		The economic and regulatory advantages of using Singapore to supply global studies

		Overcoming challenges in running clinical trials in the APAC countries

		Singapore’s import and export capabilities to support the APAC region

		The importance of clinical supply management to optimize strategy and support timely execution of trials

		Customs influence on returns and destructions

Julie Delaney, Director, Clinical Supplies and Project Management, APAC, Catalent

	Rognvald Lamb, Director, Transportation Services, Clinical Supply Services, Catalent


	US & Europe Broadcast: Wednesday, Feb. 19, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET

	Asia-Pacific Broadcast: Thursday, Feb. 20, 2020 at 8:30am IST | 11am CST | 12pm JST

	On demand available after airing until Feb. 19, 2021

How can you overcome clinical import and export challenges within the Asia-Pacific region? Join Catalent’s Julie Delaney and Rognvald Lamb as they present the advantages of using Singapore as an APAC clinical supply hub. 
Live: US & Europe Broadcast: Wednesday, Feb. 19, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET 
Asia-Pacific Broadcast: Thursday, Feb. 20, 2020 at 8:30am IST | 11am CST | 12pm JST 
On demand available after airing until Feb. 19, 2021 
Register free


Supply Chain Models for Global Trials: Singapore as the APAC Gateway to the World

	From its early-phase drug development centres of excellence in Nottingham, United Kingdom, Somerset, NJ, and San Diego, CA, and network of manufacturing facilities, Catalent offers partners end-to-end solutions, encompassing early drug product formulation and dose form design, through to clinical supply, commercial-scale manufacturing and lifecycle management.

	For early development, these solutions include analytical, pre-formulation, and formulation technologies, and  a comprehensive bioavailability enhancing technology toolkit including lipid formulation, spray drying, and hot melt extrusion. Its experience sees Catalent support the development and launch of over 100 new products every year.

	By adapting for each molecule’s unique characteristics and challenges, Catalent uses its experience and a wide range of tools and technologies to create dose forms that benefit patients.

	Catalent’s multi-award-winning OptiForm Solution Suite platform can assist in the development of innovative dose forms that can improve a drug’s efficacy and success. OptiForm Solution Suite is fast, flexible, and fact-based, combining the broadest selection of enabling technologies to ensure the right decisions are made at each stage of development.

With global development and manufacturing sites, Catalent combines its formulation and bioavailability enhancement experience, along with delivery technologies to support the launch of more than 100 new products every year.

Bioavailability and Development Toolkit

Catalent’s new 28,000 square-meter (305,000 square-feet) facility in Anagni, Italy

 has a demonstrated track record in technical transfers and successful commercial product launches and will enhance its European biologics business by providing customers with access to:

	- Liquid and powder filling of vials for sterile and biologic products

	- Secondary packaging for sterile and biologic products, including labelling and cartoning

	- Automated inspection, packaging, and warehousing

	- World-class expertise in global product launches

	The state-of-the-art facility for late phase tech transfers and commercial launches complements Catalent Biologics' existing facilities in Brussels, Belgium, providing process development, filling of syringes for sterile and biologic products, and device assembly and packaging.

	The site will also offer oral solid dose commercial packaging capabilities and work alongside facilities in Schorndorf, Germany and Nottingham, United Kingdom to accelerate late-phase tech transfers and commercial product launches.

Catalent’s site in Anagni, Italy offers extensive capabilities in aseptic liquid and powder filling, as well as comprehensive packaging solutions to support product launches for oral solids, sterile, and biologics products.