The theme of the 2021 Annual Meeting & Expo is agility, collaboration, and innovation, and these were demonstrated from a number of perspectives in the keynote presentations during the...

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

Raymond G. Perelman Center for Cellular and Molecular Therapeutics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention...

Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations at United Therapeutics Corporation. During his career, Erich has led the process activities for several biopharmaceutical projects, provided internal and external project leadership, is a...

Locus Biosciences is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their...

There are many benefits to networking. In addition to strengthening business connections and meeting new people, it can help you discover new ideas and gain a fresh perspective on topics in the life sciences and pharmaceutical industries. It can help you advance your career and learn about new opportunities. Done properly, networking can introduce you to people that will become mentors and...

ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of...

One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production in less than a year after scientists successfully revealed the virus's genetic code in January of...

Biocon Biologics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their Biocon Biologics Manufacturing (B3) project in Bangalore, India.

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are highlights from the magazine ten years ago in 2011. Revisit articles on single-use in biomanufacturing, contained...

Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “

Grand River Aseptic Manufacturing is the 2021 Facility of the Year Awards Winner for 2021 Special Recognition Award for Operational...

The strength of ISPE’s global network of Affiliates and Chapters is critically important in achieving ISPE’s mission to be the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture, and reliably deliver quality medicines to patients....

Apply for an ISPE grant to attend the 2021 ISPE Annual Meeting & Expo and a one-year ISPE Membership.

If you have less than five years of experience in the pharmaceutical or life sciences industry, you could be eligible to receive a grant to attend the

Pharmaceutical Engineering^® is delighted to announce the finalists for the 2020 Roger F. Sherwood Article of the Year...

Introduction

The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new

Gilead Sciences, Inc. is the 2021 Facility of the Year Awards Winner for 2021 Special Recognition Award for...