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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

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

Fedegari’s FOB5 Redefines Sterilization with Compact Design and Full GMP Compliance

Discover how Fedegari’s FOB5 is redefining sterilization with compact design, GMP compliance & high-containment capabilities.

Training: The Real Constraint in CGT Manufacturing

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.

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.

Collaboration and Innovation are at the Heart of AustinPx’s ASD Workshop

The biannual AustinPx Amorphous Solid Dispersions (ASD) Workshop is a place for collaboration and innovation. Hear firsthand from attendees about challenges and insights from the front lines of amorphous drug development.

A Discussion: In Vitro Release Testing and Its Application and Use in Generic Topical

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.

How CDMO Alliances Can Provide End-to-End Service that Reduces Drug Development Time and Costs

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs.

Accelerating HTA Readiness with Generative AI

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

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.

How Codexis is Redefining Pharma Biocatalysis

Mandy Vink, VP of Business Development at Codexis, explains how the company leverages over 20 years of expertise in small molecule APIs to advance biocatalysis across pharma.

Integrated Contamination Control Solutions for Biopharma

Program overview brochure for Ecolab’s Biopharma offering

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Inside Lonza CHI’s Innovation Strategy: Future-Ready Capsules for Complex Drugs

How Lonza Capsules & Health Ingredients (CHI) is redefining drug delivery with cutting-edge capsule innovation, customer-first service, and a strong commitment to sustainability

The Role of Flavoring Agents and Taste Modulation Strategies in Drug Development

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.

Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.