Catalent

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.

Articles

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.

Catalent Unveils New European Product Launch Site

Strategies for Testing Host Cell Proteins

	The use of spray drying to manufacture amorphous dispersions is continuing to grow due to the number of drug candidates exhibiting poor solubility. Nearly 40% of the new chemical entities (NCEs) screened by pharmaceutical companies fail to progress to later stages of development due to poor aqueous solubility.

  The application of a phase-appropriate quality-by-design (QbD) framework increases the understanding of the interplay between the process parameters of spray drying and product quality that, when applied during scale-up, increases the chances of a successful outcome of the commercial manufacturing process. 

 Roots Analysis Business Research & Consulting, Pharmaceutical Spray Drying Market, 2nd edition, 2018-2028.

		Determining when spray drying is the right technology for bioavailability enhancement

		The importance of process and formulation parameters that need to be addressed for successful commercial scale-up

		The importance of the optimization of process parameters; what could go wrong if not executed correctly

		How integrated services can minimize risk and save cost and time on development and manufacturing process

Ryan Minikis, Principal, Arclight Pharmaceuticals, LLC

	Jon Scrafford, Director, Engineering & Continuous Improvement, Catalent

Tuesday, Nov. 19, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET

	On demand available after airing until Nov. 19, 2020

Webcasts

The application of a phase-appropriate quality-by-design (QbD) framework increases the understanding of the interplay between the process parameters of spray drying and product quality that, when applied during scale-up, increases the chances of a successful outcome of the commercial manufacturing process. 
Live: Tuesday, November 19, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET 
On demand available after airing until Nov. 19, 2020 
Register free


An Integrated Approach to Spray Drying: From Scale-Up to Manufacturing

	A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success.

	Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. In this webcast, industry experts will review key topics to consider when planning for scale-up of a development program. Real-life examples will illustrate issues that have resulted in ineffective technology transfers-and strategies that can be employed to overcome these issues. Join this webcast to learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach.

		Areas of focus when planning for the natural evolution of a development program

		Potential problems that could arise during technology transfer

		How using an integrated approach to scale up can reduce risk and shorten timelines

Lisa Caralli, Director, Science & Technology, Catalent

	Matthew Rota, Program Manager, Catalent Pharma Solutions

	Jim Spavins, Principal, Spavins Consulting LLC.

Thursday, Oct. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Oct. 24, 2020

Join this webcast to learn how to avoid common pitfalls in the tech transfer and scale-up process using an integrated approach. 
Live: Thursday, Oct. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST 
On demand available after airing until Oct. 24, 2020 
Register free


A Roadmap for Early Development to Commercial Manufacturing

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


	Pharmaceutical and biotechnology companies value streamlined services from early-phase development to clinical supply services to commercialization. These services can not only provide improved efficiencies, such as the ease of transition from one development phase to the next, but also remove the challenges of dealing with multiple vendors when transitioning into clinical supplies and commercial availability.

	Join experts for a discussion on how contracting with a single service provider can offer significant benefits to the customer through:

		Integrated expertise between the formulation development teams, the manufacturing teams, clinical supply specialists, and the packaging teams

		Consistent exchange of information between the teams and retention of critical product knowledge gained over time

		Flexibility of selection of dosage form based on a wide variety of technologies

		Time and cost-saving benefits of integrated offerings and streamlined communications

		Identify opportunities to streamline product development and shorten timelines

		Explore strategies to reduce the risk of avoidable delays during product development

		Understand how dosage form selection can shape future decisions and project trajectory

		Understand the pros and cons of working with a single integrated provider

	Ann McMahon, Customer Service Excellence Manager, Catalent

Tuesday, Sept. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Sept. 24, 2020

Join experts for a discussion on how contracting with a single service provider can offer significant benefits to the customer. 
Live: Tuesday, Sept. 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after airing until Sept. 24, 2020 
Register free


The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success


	Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based bioassays and binding assays, including applications, advancements, and outlook. The discussion will focus on a variety of assays including antibody-dependent cellular cytotoxicity, Octet, AlphaLISA, and Host Cell Protein (HCP), as well as the potential application of automation.

	In this webcast, a panel of four industry experts will unravel the science and dive into some specific applications, providing useful information for both novices and experts. The presentation will be followed by a roundtable discussion, where the panel will discuss registrant-submitted questions and address current issues and trends within bioassays and binding assays.

	Register now to submit a question for the experts!

		Fundamentals on how various assays work, when they should be used and what questions they answer

		Differences between various bioassays and binding assay

		Application of immunochemistry-based platform technologies to analyses of biologics

Michael Sadick, PhD, Principal Scientist, Biologics Analytical Development, Catalent

	Dan Papa, PhD, Group Leader, Biologics, Catalent

	Eric S. Bishop, Vice President of Research & Development, Cygnus Technologies, LLC

	Jeff Dixon, Field Application Scientist, PerkinElmer

Thursday, Sept. 19, 2019 10am EDT | 9am CDT | 3pm BST | 4pm CEST

	On demand available after airing until Sept. 19, 2020

This webcast will describe one solution:  Working with a clinical supply partner to handle the packaging and potential complex distribution logistics for expanded access programs and commercial supply. 
Live: Thursday, Sept. 19, 2019 10am EDT | 9am CDT | 3pm BST | 4pm CEST 
On demand available after airing until Sept. 19, 2020 
Register free
