iSpeak Blog
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already impacting manufacturing and quality control processes. Recent advancements and best practices will be showcased at the upcoming 2025 ISPE Biotechnology Conference, where the track “Implementing Digital Initiatives in the Biopharmaceutical Industry: Where Are We on the Road Map?” dives deep into the...
iSpeak Blog

Pharma 4.0™ represents a transformative shift within the pharmaceutical industry, redefining how medicines are developed, manufactured, and delivered. At its core, Pharma 4.0 involves the integration of advanced digital technologies...

19 June 2025 - 19 June 2025
Join us on June, 19th at UCB, Anderlecht (BE), for an exciting GAMP event on the " validation of SaaS systems”. Learn from experts in the field in how to manage SaaS vendors and what measures you can take to ensure a SaaS system is maintained in a...
5 May 2025 - 5 May 2025
All spots to play golf in the outing are sold out! The response we received from our annual chapter sponsors and previous outing sponsors was truly remarkable! However, don’t let this stop you from joining us on May 5. Visit the registration site to...
iSpeak Blog

Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that support it. Therapeutic modalities are becoming more diverse, and with the increasing demand for speed, flexibility, and sustainability in production, biopharmaceutical facilities must be prepared to meet these new challenges.

iSpeak Blog
As biotechnology continues to advance at an extraordinary pace, organizations face a common challenge: how to keep up with increasing complexity while accelerating speed to market. From biosimilars and bio-betters to cell and gene therapies, advanced therapy medicinal products (ATMPs), and mRNA-based treatments, the industry is transforming, and so too must the tools the industry uses to develop...
iSpeak Blog

Nathan Roman is a Director, Industry Advisor, and Global Brand Ambassador with Ellab. He has been an ISPE Member since 2004. In the question-and-answer interview below, Roman reflects on why he joined ISPE, how ISPE has impacted his career, and more.

5 June 2025 - 5 June 2025
Date: Thursday, June 5, 2025 Time: 5:00 – 7:00 PM Location: MECO Group, Hayward Water Purification Sustainability Considerations As a critical process utility, water sustainability is often a tradeoff between risk and sustainability rewards. A...
Good Practice Guide: Digital Validation
This Guide considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. However, the transition from traditional, paper-based validation to a digitally integrated framework remains a complex challenge.
19 May 2025 - 19 May 2025
2025 ISPENJ Annual Golf Outing & Winery/Brewery Tastings Monday, May 19, 2025 Registration closes May 16, 2025 ISPE NJ Chapter Golf Outing and Winery/Brewery Tastings Monday, May 19, 2025 Lunch, buffet dinner, door prizes, drinks, and networking Non...
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