Authors

Q&A: AI Coding Tools Carry the Real Risk

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

Reimagining Signal Management: How Autonomous Pharmacovigilance Could Render Reporting Timelines a Thing of the Past

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the case-processing pipeline. End-to-end ICSR autonomy may enable near-instantaneous case processing so that current SUSAR targets become obsolete.

Multi-Compendial Compliance for Pharmaceutical Excipients–Part 2: A Detailed Assessment for Specification Equivalence

This paper provides a technical assessment of compendial tests commonly found in the European Pharmacopoeia, the United States Pharmacopeia–National Formulary, and the Japanese Pharmacopoeia, detailing differences between the methods and acceptance criteria, and the potential impact of these differences on multi-compendial compliance.

Rare Disease Therapies: How Orphan Drugs Are Reshaping Global Biopharma Sourcing

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

A Capsule-in-Capsule Platform for Multi-Phase Release of Liquid and Solid Formulations

A dual delivery capsule platform provides delivery of multiple APIs with a single dosage unit, which reduces pill burden and simplifies dosing regimens.

Optimizing Impact for Rare Diseases

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems.

BioDuro is Redefining CRDMO Partnerships With End-to-End Innovation

How BioDuro is expanding its global CRDMO footprint by improving integrated capabilities and delivering high-quality, end-to-end solutions for drug development and manufacturing

SK pharmteco’s Three-Business-Unit Strategy: Small Molecules, Peptides, and Viral Vectors

Joerg Ahlgrimm, CEO of SK pharmteco, outlines the company's strategic expansion into cell and gene therapy. He also details their commitment to global operational excellence and a culture of employee purpose.

Streamlined Product Development Leveraging Pharmaceutical Classification Models

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Ensuring the Supply Chain through Purchasing Controls

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

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Is Your Annex 1 Strategy a Static Document or a Dynamic Defense?

Contract development and manufacturing organizations can assist the sponsor company in ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

Strengthening Sustainability Through Smarter Ingredients: Designing Resource‑Efficient Formulations

Excipients contribute to more sustainable practices throughout the life cycle of a drug.

Making Critical Therapies More Accessible with Nasal Sprays

Drug Digest: How Advanced Analytics Partnerships Enhance the Biopharma Value Chain

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

Sustainability by Design: Re-Imagining Amorphous Dispersion Manufacturing

A comprehensive approach to long-term sustainability efforts in pharmaceutical manufacturing should prioritize simpler frameworks that curb costs, risks, and variability.

How Innovation Is Reshaping Outsourced Development and Manufacturing

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before uncertainty becomes late-stage risk.

Entering New Domains for 3D Printing of Drug Products

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Fresenius Kabi Contract Manufacturing: Focused on Your Success

Saleem Farooqui of Fresenius Kabi explains how the company is addressing today’s pharmaceutical manufacturing needs. Watch this video to learn how these capabilities can help bring products to market successfully.

Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access Programs

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Sustainable Alternative: PFAS-Free-TPE for Pharmaceutical Stoppers

Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more sustainable product.

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT