Industry Trends on Stage at INTERPHEX

Equipment and Processing Report

Equipment and Processing Report, Equipment and Processing Report-03-15-2017, Volume 10, Issue 4

A Keynote Series includes presentations by experts in serialization and traceability, continuous solid-dosage manufacturing, cleaning validation, and post-approval changes.

At INTERPHEX 2017, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series that will be held on the INTERPHEX Innovation Stage. The presentations On Tuesday, March 21, the morning session will feature experts in supply chain and serialization, and the afternoon session will look at continuous manufacturing of solid-dosage drugs. On Wednesday, March 22, the morning session will introduce an ASTM standard for cleaning validation, and the afternoon session will address the challenges of post-approval changes

Serialization and traceability

With the November 2017 US Drug Supply Chain Security Act (DSCA) implementation deadline just months away, companies need to put compliance plans in place if they haven’t already. At the INTERPHEX session, Vivek Nadadur, Program Director for End-to-End Traceability at J&J Supply Chain will discuss best practices for connecting with distributors, and Graham Clark from TraceLink will share insights into gauging CMO partners’ readiness for serialization. Experts from Ropack and Systech International will discuss the quick compliance initiatives they recently launched and how they can help companies and their supply chain partners meet DSCSA requirements by the deadline. At the end of the session, Robert Celeste, Founder, Center for Supply Chain Studies, and Darryl Glover, chief clinical officer, i-Solve, will examine BlockChain, used for secure online transactions, and how it might be used in the pharma industry. 

To learn more about these topics, read these recent articles and others on PharmTech.com

 

Continuous manufacturing of solid-dosage drugs

Continuous manufacturing of solid-dosage drugs has moved from the laboratory to commercial-GMP production, but there are different approaches that can be taken. Bayan Takizawa, MD, MBA, Co-Founder & Chief Business Officer, CONTINUUS Pharmaceuticals, Inc., will describe some of these approaches. Pamela (Bruen) Docherty, Life Sciences Industry Manager for Siemens in the US, will explain the mechanisms of implementing an integrated automation approach and process analytical technology in continuous manufacturing. Doug Hausner, associate director for Industrial Relations and Business Development at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers University, will present some of the newest innovations for faster development of products using less material, along with programmatic activities aimed at easing the regulatory pathway for continuous manufacturing.     

To learn more about these topics, read these recent articles and others on PharmTech.com

Cleaning validation

The American Society for Testing and Materials (ASTM) is finalizing the “Standard Guide for Science and Risk-based Cleaning Process Development and Validation.” Andrew Walsh, President of the Center for Pharmaceutical Cleaning Innovation; Mariann Neverovitch, research scientist at Bristol-Meyers-Squibb; and Igor Gorsky, consultant, Valsource, will discuss various aspects of the new standard in presentations on Wednesday, March 22 (10:30–12:30).

Post-approval changes

The Parenteral Drug Association (PDA) formed a task force to address the concern that the complexity of post-approval changes is hindering modernization of facilities. Maik Jornitz, G-Con LLC, and member of the PDA Innovation for Availability of Medicines (PAC iAM) Task Force will discuss findings from the task force’s activities.

Kashappa Goud Desai, PhD, Biopharmaceutical Product Sciences, GlaxoSmithKline, will describe bracketing strategies for filing drug applications for the Japanese market. Different strategies can show whether pre-approval for implementation of a post-approval change is required or not. These two presentations will take place on Wednesday, March 22 (1:30–3:00). 

The Innovation Stage, open to all exhibit hall attendees, is located on the far left side of the exhibit hall, towards the back, in front of the meeting rooms  (#1170).