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How the Critical Medicines Act Aims to Optimize European Pharma Competitiveness and Resilience

Maggie Saykali reviews the key points of her CPHI Frankfurt presentation on the potential game-changing opportunities of the Critical Medicines Act.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

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

Streamlined Product Development Leveraging Pharmaceutical Classification Models

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Making Critical Therapies More Accessible with Nasal Sprays

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.

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.

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.

Pushing the Boundaries: Overcoming Formulation and Manufacturing Challenges in Today's Pharmaceutical Development Landscape

As molecules grow more complex, drug developers in the pharma landscape face an increasing number of challenges in formulation, manufacturability, and sustainability. Fortunately, novel formulation strategies and technologies are reshaping drug development, from overcoming oral solid dose (OSD) challenges to advancing bioavailability and redefining traditional drug-likeness criteria.

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.

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.

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.

Guidance on Quality Culture Standards

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Resilience and Precision in Pharma Development

Success depends on collaboration, resilience, and a focus on improving outcomes for patients worldwide.

Effectively Using Contamination Control Strategies

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

In-line UV Spectrometry Monitoring in Cleaning Validation

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

ROSS Ribbon Blenders - Video in Action

ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.

In-line UV Spectrometry Monitoring in Cleaning Validation

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.