July / August 2023

ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD

Marcy Sanford
A Comprehensive Reference for Continuous Manufacturing of OSD

The pharmaceutical industry began applying the principles of continuous processing to the manufacture of oral solid dosage (OSD) forms in the mid-2000s. The consensus among experienced practitioners is that the continuous approach has numerous benefits. “Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial production, with minimization or elimination of scale up activities, all leading to Real Time Release. It offers potential safety benefits and requires a smaller facility footprint,” said Guide Co-lead Dave DiProspero, Director of Pharmaceutical Process Technology, CRB.


Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage FormsHowever, there are still many challenges to widespread adoption. The ISPE OSD Community of Practice formed a working team in 2017 to advance the use of continuous manufacturing in the pharmaceutical industry and to increase the long-term efficiency and affordability of the manufacture of OSD products. The team, composed of end user pharmaceutical companies, equipment vendors, and academics, set out to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest enhancements to current equipment. The collective output forms the basis for the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms.

The consensus among experienced practitioners is that the continuous approach has numerous benefits.

“This guide is intended to serve as a comprehensive reference for continuous manufacturing of oral solid dosage forms, providing guidance for pharmaceutical companies, regulators, engineering firms, and vendors engaged in this emerging technology,” said Guide Co-lead Gregory Connelly, Senior Director, Continuous Manufacturing, Vertex Pharmaceuticals.

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Newly Released

ISPE Drug Shortages Prevention Model: Guidance for Drug Shortage Prevention Excellence

ISPE Drug Shortages Prevention Model: Guidance for Drug Shortage Prevention Excellence

The ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. The ISPE Drug Shortages Task Team developed the model as a follow up to the ISPE Drug Shortages Prevention Plan that was released in 2014. The model provides expanded guidance that reflects the new insight and best practices that have emerged in the past several years.

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Meet the ISPE Staff: Edyna Miguez

Meet the ISPE Staff Edyna Miguez

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Edyna Miguez, Membership Growth Manager.

Tell us about your role at ISPE: What do you do each day?

As Membership Growth Manager, I communicate the opportunities and bene ts available through an ISPE membership to active and prospective members. This often includes collaboration with Affiliate and Chapter leaders and passionate members, which is one of the best parts of my job. I take great pride in helping our members make the most of their experience by leveraging the ISPE network and resources to advance their careers and make their mark on the industry

I also work as Program Manager for Women in Pharma®. This quickly turned into both a passion project and a large part of my daily responsibilities. I feel so fortunate to be able to work on it so closely.

Through Women in Pharma programming, I get to collaborate with incredible pharma professionals across the globe, all of whom are working to create a more equitable pharmaceutical industry. I’ve seen the program mature in such a short amount of time thanks to the commitment of our volunteers and International Steering Committee. I’m excited to continue watching it flourish and make an impact as it applies to diversifying the industry and making the world a more inclusive place.

What do you love about your job?

I love the international component of what we do. I really enjoy meeting members from different parts of the world, learning from their experiences, and gaining new perspectives. Through our many conversations, both in person and online, I’ve gained a better understanding of the various cultures that make up the ISPE member base.

Our members are inspiring, and the work they are doing is incredible, especially when they share their motivations. When you realize how much they believe in the work they are doing, and how improved patient lives and quality of life are their driving force, you can’t help but be truly inspired. I absolutely love knowing that I can help them on their journey in the smallest way as they continue to save the world. It allows me to feel like I’m a part of something much larger than myself, and that I’m making a real impact.

What do you like to do when you are not at work?

When I’m not at work, I am spending time with my little family. My husband and I have a three-year-old son and two dogs. We love to travel with our son, which at this stage includes plenty of trips to Disney World. We try to visit at least one new city a year, and we try to escape a few times a year for long weekends and resets. When we’re not traveling, we remain very activity-driven; we spend our weekends at the zoo or local science museum, hoping to nurture our son’s natural curiosity for the natural world and anything science. We are lucky to live close to family and old friends, and so we spend a lot of time at family gatherings. We love to try new foods and are constantly discovering new restaurants, andI love to indulge in pop culture (anything Bravo, please!).