FDA/PQRI Workshop on the Regulatory Framework for DM and POC Manufacturing – Day 2

FDA/PQRI Workshop Organizing Committee

Session 3 will explore the regulatory challenges, risks, and opportunities associated with the location, size, and mobility of the DM/POC site as compared to traditional manufacturing sites. The speakers will also discuss the strategies to demonstrate comparability of product quality between different DM/POC locations.

Dennis Powers, M.S., Vice President, Business Development & Design Consulting, G-CON

Changes in the global manufacturing and supply chain landscape coupled with advances in personalized medicine and process innovation are driving the biopharm industry to consider decentralized strategies including both distributed and point of care manufacturing. The realization of this capability is dependent upon the adoption of innovative transportable process and facility platforms which are currently being utilized and advanced within the industry. The presentation will provide an overview of the industry drivers for distributed manufacturing, the modalities that are considering this capability, as well as examples of various transportable technology options that are available and can be leveraged to support to support distributed manufacturing. The benefits and considerations for implementation will also be addressed.

Fred Parietti, Ph.D., CEO and Co-Founder, Multiply Labs

This talk focuses on an automated production process for the manufacturing of personalized drug products in a consistent and controlled way. Particularly, we developed a modular system able to fulfill the needs of a small-batch, high-mix, personalized, or even on-demand, production thanks to a fully automated architecture (i.e. hardware and software). In this respect, we have developed a robotic cluster, consisting of i) different manufacturing modules, each of them performing specific fabrication steps, and ii) a transfer system that moves work-in-progress units (WIPUs) from module to module in a distributed and parallelized way. WIPUs are shuttled into a given module, which performs a specific step of the process and then conveyed out of the module for the next operations, including quality controls. This sequence can be performed in a fully-planned manner, fixed-scheduled manner, a flexible-scheduled manner, or a dynamic manner, being everything monitored locally and in the cloud.

The strategy pursued not only ensures security of the manufacturing systems but increase its versatility and flexibility while making the proposed architecture suitable for scaling, being able to deploy many clusters at the same time in different distributed points.

• • Dennis Powers, M.S.
  • Fred Parietti, Ph.D.
  • Rakhi Shah, Ph.D., Associate Director for Science and Communication, Office of Pharmaceutical Manufacturing Assessment (OPMA)/ OPQ/CDER/FDA (Invited)
  • Christine Moore, Ph.D., Executive Director, Organon

Session 4 will explore how the PQS can assure oversight of DM and POC technologies and the sites to which they are deployed to ensure compliance with CGMP. Additionally, this session will probe what changes, if any, are necessary to a PQS if DM and POC technologies are employed.

Celeste Frankenfeld Lamm, Ph.D., Director, Global Regulatory Affairs, CMC, Merck & Co., Inc.

Distributed manufacturing is a shift from traditional drug product manufacture, that enables the same manufacturing process to occur in multiple different locations.  When the same equipment, process, controls, and quality systems are used, risk that may arise due technology transfer to a new location is reduced.  A critical factor in the reduction of risk is quality systems; this talk will share perspectives regarding how a manufacturer can ensure compliance with CGMPs, approach Quality Risk Management, generate-maintain-and-access batch records, and control raw materials for distributed manufacturing.

Paul Smolenski, Regulatory Director, DEKA Research and Development

Point-of-Care pharmaceutical manufacturing is a nearly self-contained manufacturing system located in virtually any healthcare setting and operated as “vendor equipment” by the host site end user where requirements are limited to providing minimal utilities and support. This vision requires a site agnostic approach to quality and compliance. The vision is enabled by robust process validation and a central quality unit that monitors Point-of-Care fleet performance. This presentation will discuss quality and compliance attributes necessary to enable point-of-care pharmaceutical quality system implementation.

• • Celeste Frankenfeld Lamm, Ph.D.
  • Paul Smolenski
  • Ashley Boam, Ph.D., Director, Office of Policy for Pharmaceutical Quality/CDER/FDA

Registrants will breakout into several concurrent breakout sessions to facilitate small group discussions