Following an unprecedented two years in which the pharmaceutical industry has faced numerous challenges posed by the global pandemic, pharmaceutical manufacturing has had to react and respond to meet the rapidly changing requirements and timelines. This has necessitated a radical rethink in how we approach pharmaceutical manufacturing and how we meet the expectations of the market and patients...

Continuous manufacturing (CM) is gaining traction in pharmaceutical manufacturing. The purpose of this post is to highlight some of the differences between small molecule Drug Substance (DS) and Drug Product (DP) continuous manufacturing (CM), which may be helpful in considering the development and execution of CM for pharmaceutical manufacturing. The following are the key differences from our...

Gaelle Saint-Louis is the Women in Pharma® (WIP) Chair of the ISPE San Diego Chapter. She began her involvement with ISPE as the Young Professional (now Emerging Leaders) Chair for the Greater Los Angeles Chapter in 2019. After relocating to San Diego, she took on a leadership role within the Chapter's Women in...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are answers to our most frequently asked questions about publishing in PE. We welcome submissions from members and nonmembers and have a wealth of information available to help guide your journey to becoming a published PE author.

If you take care of your employees, they will take care of your customers. Once you stop treating people like functions or costs, disengaged workers begin to share their gifts and talents toward a shared future.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.

It goes without saying that reflecting on the last few years, immense progress has been made in the biopharmaceutical industry. We have seen an industry prioritising collaboration and innovation, combined with a healthy competitive spirit, brought new technology to reality, and achieved milestones in twelve months that would previously have taken a decade.

The exponential increase in demand to manufacture therapeutics including vaccines triggered by the pandemic has stressed the supply chain for single-use products.

It would be easy to say that the pandemic has driven dramatic growth for CDMO companies, as more pharmaceutical firms seek to outsource. Really though, the trend started much earlier, with many CDMOs having put their massive expansion plans in place a year or more before the pandemic took hold.

The ISPE South Central Chapter recently hosted their Inaugural South Central Chapter Education Seminar from College Station, while live-streaming in Austin, Houston, Dallas-Fort Worth Area (DFW), and The University of Oklahoma. Each city hosted an in-person networking dinner followed by the sessions on Vaccine/Gene Therapy Manufacturing and Writing User Requirements Specifications.

mRNA is back at the 2022 ISPE Biotechnology Conference. Last year we learned from major key players about their journey to develop first time mRNA vaccines against COVID-19 and build manufacturing capacity for billions of doses in less than one year. In 2022 we are revising the relevance of mRNA technology and widening the view beyond the COVID vaccine.

ISPE’s ICH Q12 Implementation Team, a technical team under the auspices of ISPE’s Product Quality Lifecyle Implementation (PQLI)® committee, recently worked with Health Canada (HC) to develop and...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Quality Risk Management (QRM) guidance was signed off by ICH in November 2005 as one of a suite of guidelines alongside Q8, Pharmaceutical Development, Q10, Pharmaceutical Quality System and later, Q11, Development and Manufacture of Drug Substances, which describe the science- and...

ISPE’s Analytical Method Strategy/ICH Q2(R2) & Q14 team, a working group within ISPE’s Product Quality and Lifecycle Implementation (PQLI)® Committee, to lead ISPE’s comments on the ICH documents to regulatory authorities.

A panel discussion held on 26 April during the 2022 ISPE Europe Annual Conference focused on Sustainability, Annex 1 Revision Implementation, and Good Engineering Practice and highlighted the many linkages...

A panel discussion held on 27 April 2022 during the 2022 ISPE Europe Annual Conference focused on Digital Transformation.

Think Tanks are meant to mobilize expertise and ideas to influence processes and procedures and help address global issues – a concept perfectly in line with the goals and mission of ISPE, the pharmaceutical industry’s largest nonprofit association committed to connecting over 20,000 peers across 90 countries. Through online and in-person forums, ISPE members can gain industry knowledge, learn...