iSpeak Blog
Biotech has a huge impact on our world. Biotech innovations provide novel treatments to cure diseases such as cancer and Alzheimer’s syndrome. Biotech brings new, sustainable products to the market. Biotech companies already conquer the world’s beef and...
iSpeak Blog
Regulators from three global agencies—US FDA, MHRA, and Brazil’s ANVISA—discussed how their agencies are addressing emerging therapies during the “Global Regulatory Town Hall” on 6 November at the 2018 ISPE Annual Meeting & Expo. “Precision medicine...
iSpeak Blog
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
iSpeak Blog
Each year during the ISPE Annual Meeting & Expo, the ISPE International Honor Awards Committee acknowledges exceptional efforts, recognizing individual volunteers, affiliates and chapters, students, the company of the year, and the Facility of the...
iSpeak Blog
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo. The opening plenary on Sunday, 4 November provided a strong kickoff to the four-day conference, whose theme of “Vision to Reality”...
iSpeak Blog
Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Sunday, 4 November | 0700–1800 Monday, 5 November | 0700–1730 Tuesday, 6 November | 0700–1730 Wednesday, 7 November | 0700–1130 Expo Hall Hours Sunday, 4...
iSpeak Blog
Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of challenges from engineer driven tasks like filling accuracy and machine performance to pharmaceutical key questions like...
iSpeak Blog
Philadelphia, the "City of Brotherly Love", is home for the second time to our 2018 ISPE Annual Meeting & Expo! What better a place to host our annual conference than the second-largest city on the east coast and one of the top 10 pharma hubs in...
iSpeak Blog
The 2018 ISPE Annual Meeting and Expo is less than two weeks away and time is running out to register for the pharma event of the year. Philadelphia - the city of “Brotherly Love” – will host this year’s Annual Meeting and provide an amazing educational...
iSpeak Blog
The benefits of being a mentee are fairly clear, but people don’t often think about the great rewards gained by being a mentor. By the time you feel like you have the experience to be a mentor, you may wonder how you could fit that into your hectic...
iSpeak Blog
Emergent BioSolutions, Inc. is one of two 2108 Facility of the Year Honorable Mention winners for their BARDA– Emergent Center for Innovation in Advanced Development and Manufacturing (CIADM) Baltimore Facility Expansion project in Baltimore, MD,...
iSpeak Blog
With less than a month to go, we are now working with our industry and regulatory colleagues to finalize the sessions for the Quality Systems and Regulatory Track for the 2018 ISPE Annual Meeting & Expo. The program is looking fantastic. We kick...
iSpeak Blog
By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation of combined products like antibody drug conjugates...
iSpeak Blog
David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined ISPE in 1988 and recently retired from AbbVie, formerly Abbott Labs. Dave has been a...
iSpeak Blog
The Trend Supply chains that span the globe can be challenging to monitor, leaving opportunities for error and diversions. As manufacturers around the world strive to maintain – and improve – safety in an increasing globalized supply chain,...
iSpeak Blog
Have you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience. Advanced Therapy Medicinal Products (ATMPs) are new state of the art therapies that...