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iSpeak Blog
The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA...
iSpeak Blog
I’ve been involved in Women in Pharma at ISPE since its inception. I’ve been a proud supporter and contributor to the group. Today, more than ever, I have an unwavering belief that this group is invaluable. In light of the recent COVID-19 crisis that has...
iSpeak Blog
We are in a current state that leaves us at home, or likely with a bit more time on our hands that may be of help to our Women in Pharma® initiative at ISPE.  We are getting creative on how to keep our membership engaged and would greatly appreciate your...
iSpeak Blog
Pharmaceutical Engineering is introducing a new part of the Pharmaceutical Engineering Online site: Online Exclusives. This content will be published only to the ISPE web site—it will not be published in print. Read on for FAQs about this new feature,...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
iSpeak Blog
As we continue to monitor the COVID-19 pandemic, our thoughts are with our Members and those impacted. We recognize that the ever-changing impact of this novel virus is disruptive to so many aspects of our personal and professional lives. We are not...
iSpeak Blog
One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient...
iSpeak Blog
ISPE places the health and safety of its members, staff, and the broader ISPE global community as its top priority. As the COVID-19 outbreak continues, the ISPE Drug Shortages Initiatives Team encourages everyone to follow the available safety and health...
iSpeak Blog
ISPE 2020 Aseptic Conference - Day 1 The 2020 ISPE Aseptic Conference kicked off on schedule Monday 2 March with a full complement of programs, speakers, and more than 200 attendees, despite the spread of COVID-19 around the world. It was business as...
iSpeak Blog
The biopharma industry is changing at a fast speed in response to the real pressures that it currently faces for producing an increasing number of complex therapeutic molecules, faster, with consistent high quality, and cost-effective manufacturing...
iSpeak Blog
The pharmaceutical industry’s work on developing treatments and vaccines for COVID-19 (novel coronavirus) is moving forward, including these recent developments: Gilead’s remdesivir treatment is in clinical trial in China, and the company announced it...
iSpeak Blog
It’s hard to believe, but it was 10 years ago when I gave my first presentation on continuous manufacturing for pharmaceuticals. It was at the ISPE Nordic Conference in Copenhagen in 2010, and I was still at FDA at the time. Looking back, it’s...
iSpeak Blog
Wendy T. Haines, PhD, DABT, CQA Associate Director of Technical and Scientific Services PharmEng Technology I grew up in the 1970s watching my dad, who...
iSpeak Blog
In April 2010, the Eyjafjallajökull volcano in Iceland erupted for six days, wreaking havoc on air travel and supply chain activities across western and northern Europe for a month. Many companies were caught off guard, resulting in industry-wide...
iSpeak Blog
The 2020 ISPE Aseptic Conference starts in one week! Here's all the info you need to make the most of your experience. Conference Essentials Conference AgendaTravel Information Registration and Information Hours Sunday, 1 March | 1300–1700 Monday, 2...
iSpeak Blog
If you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics...