2022 ISPE Facilities of the Future Conference

Executive Forum Panel Discusses Future Pandemic Planning & Other Topics

The Executive Forum Panel at the 2022 ISPE Facilities of...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are articles about aseptic to help you get ready for the 2022 ISPE Aseptic Conference in March. Here is a selection of some recent articles, including coverage of the popular regulatory panel session at the 2021 Aseptic Conference, the ISPE Barrier Survey, and more.

It was March 2020 and my first year serving on the ISPE Aseptic Conference Planning Committee. I was brimming with excitement of the possibility to introduce speakers and facilitate discussions at this conference I had enjoyed and learned from multiple times as an attendee. Little did I know how much I would get to participate, as my fellow committee members were restricted from traveling to...

The ISPE 2022 Facilities of the Future Conference Opening Plenary provided views of lessons learned during the pandemic that will help the pharmaceutical industry to accelerate development of new...

Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. A wide range of topics falls under this umbrella, from more engineer-driven topics (e.g., filling accuracy and machine performance) to key production questions (such as how to ensure the process remains sterile and compliant within the law and regulatory guidelines). All this is influenced...

The ATMPs - Autologous Cell Therapy Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.

Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges. Join us at the 2022 ISPE Facility of the Future Conference...

Over the past decade, companies worldwide have faced increased scrutiny from consumers, investors, and regulators over how they treat the environment. They are questioned about where and how they source raw materials, the packaging they use, power consumption levels, and waste generated. Many companies understand these concerns and have taken active steps to be sustainable. Building industry...

ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

I’m from the past, but to some degree, we all are.

A number of years ago, I received my Bachelor’s degree in mechanical engineering and a desire to make the world a better place. I joined the pharmaceutical industry with that goal in mind. 30 years later, I have that same desire, but the industry looks significantly different.

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are Online Exclusives. These are PE articles published exclusively on the website; you can always find them here. Here is a selection from the first two years of Online Exclusives on...

Continuous Bioprocessing Platform

Continuous processing is not new to the pharmaceutical industry. Today, the majority of major pharmaceutical companies at least consider continuous processes when developing new small-molecule entities. In contrast, the biopharmaceutical industry has been slow to adopt continuous platforms, particularly related to high volume processes. This...

The ISPE Aseptic Conference is back and in-person for 2022! We have a great line-up of speakers during the two-day conference, and of course, a great group for the Interactive Regulatory Panel. The...

When most people hear “Facility of the Future,” they immediately think about robots, automation, virtual reality, or logging in with a Facebook account, security issues aside. However, when I hear “Facility of the Future,” I think of lean manufacturing and flexibility. The majority of my career has been on the design side, where I focused on building facilities. Historically, the projects I...

Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

A thought-provoking session held during the 2021 ISPE Annual Meeting & Expo provided insight into how the Overall Quality Summary can provide an ideal opportunity to provide a...