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Timothy Compton of Alcami shares insight on Alcami’s role in ensuring a smooth transition from development to manufacturing.
Released By Alcami Corporation
Effective DNA clearance is essential in viral vector manufacturing to ensure product purity, regulatory compliance, and patient safety. As demand for AAV and LVV-based cell and gene therapies grows, biopharmaceuticals and CDMOs must adopt scalable, high-performing endonucleases. This study evaluated Roche’s EndoCleave endonuclease against commercial benchmarks using a transient transfection platform with suspension HEK293 cells. […]
Insight on market dynamics driving OSD forms, key development and manufacturing challenges, and the specialized capabilities needed to address them.
By: Ben Locwin
Will enable the company to manufacture the vast majority of its advanced medicines in the U.S.
By: Charlie Sternberg
Meeting Global Injectable Demand
Released By Rovi Pharma Industrial Services
Powering Patient-Centric Delivery: How Partnerships Are Transforming Fill-Finish Services
AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies
CDMO Industry Trends 2025
CDMOs: Challenges & Opportunities in a Big Year of Change
Gary Ellsworth, Head of North America Alliance Management, IQVIA shares insight on key trends driving outsourcing in today’s market.
By: Gary Ellsworth
Why pharma needs automated AI security now.
By: Frank Balonis
Andrei Georgescu of Vivodyne discusses key advantages of its humanized drug testing platform and the impact of the FDA’s policy shift.
By: Kristin Brooks
Subscribe to Magazine for top news, trends & analysis
Operational strategies to optimize efficiency and cost effectiveness, and secure an unbroken chain of custody from manufacturing to the end-user.
Released By Marken, UPS Healthcare Precision Logistics
EVP & COO Todd Nelson reflects on Porton J-STAR’s defining milestones, global network strategy, and what’s ahead as the company enters its third decade.
Released By Porton
Rod Ketner on Serán BioScience’s science-first culture and what biotechs should look for in a CDMO.
Released By Serán Bioscience
Pfizer
Roche
Johnson & Johnson
Amgen
AstraZeneca
Abbvie
Merck
Sanofi
Novartis
Bristol Myers Squibb
A look at the shifting strategies and surging sectors reshaping the Top 20 drugmakers.
By: Tim Wright
Tracking industry leaders by Rx sales and strategic shifts.
Marken’s Mike Bartone, VP of Global Cold Chain Solutions Management, on scaling temperature-controlled precision logistics, driving innovation with Packaging as a Service (PaaS) and mastering the pace of change in the rapidly evolving clinical trial ecosystem.
David King of Samsung Biologics shares insights on market demand and the technologies and capabilities needed to support today’s drug products.
Released By Samsung Biologics
Effective DNA clearance is essential in viral vector manufacturing to ensure product purity, regulatory compliance, and patient safety. As demand for AAV and LVV-based cell and gene therapies grows, biopharmaceuticals and CDMOs must adopt scalable, high-performing endonucleases.
This study evaluated Roche’s EndoCleave endonuclease against commercial benchmarks using a transient transfection platform with suspension HEK293 cells. Two Proof-of-Concept studies assessed performance across key process parameters—enzyme concentration, incubation time, temperature, and salt conditions—representative of AAV and LVV production.
EndoCleave consistently matched the performance of commercially available endonuclease in reducing host cell and plasmid DNA without impacting viral titers. Its activity remained robust under varying conditions, confirming suitability for both AAV and LVV workflows.
These results suggest EndoCleave as a reliable, scalable solution for removing nucleic acid in GMP-ready vector manufacturing environments and could also be a potential cost-effective solution.
In this webinar, SGS’s Microbiology Manager, Patricia Peron, will take a deep dive into:
Stick around after the presentation for a Q&A where you will be able to submit questions.
This webinar provides a high-level introduction to Primary Packaging Qualification in the pharmaceutical industry. We'll take a systematic approach to qualifying packaging systems by examining four key factors: Compatibility, Safety, Protection, and Quality Control.
The session will also highlight relevant industry standards, including USP <381>, <382>, <661.1>, and <661.2>, and address common challenges encountered during the qualification process.
Whether you're new to the topic or seeking a refresher, this webinar offers valuable guidance and practical insights.
What you’ll learn by attending:
Vice President and General Manager of Pfizer CentreOne talks with Ben Locwin about drug development trends and challenges and Pfizer’s lightspeed approach.
Global Head of Strategic Account Management for Pfizer CentreOne talks with host Ben Locwin about the advantages of working with an integrated CDMO.
In partnership with the University of Oxford’s Pandemic Sciences Institute, the grant will advance oral vaccine delivery.
By: Rachel Klemovitch
Financing supports the execution of early-stage clinical trials for Anocca’s lead program, VIDAR-1.
Financing will help advance the late-stage pipeline and global expansion.
AC-201 is being developed to treat multiple immune-mediated inflammatory diseases.
Will increase global access to AGAMREE for patients with Duchenne muscular dystrophy.
The U.S. Food and Drug Administration (FDA) approved WIDAPLIK on June 6, 2025.
Ken McFarlane of CluePoints shares insight on better, smarter ways to detect risk, streamline data review, and automate oversight.
By: Ken McFarlane
What’s at stake in the face of enforcement deadlines and how exception management lays the groundwork for future-ready supply chains.
By: Tracy Nasarenko
Combining technology, data visualization and data expertise to enhance decision-making and efficiency.
By: Ping Chung Chang
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