Authors

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.

Driving Resilience Through Digital Innovation

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.

Excipient Selection Strategies to Mitigate Nitrosamine Risks

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Navigating Biopharma Complexity: Why Long-Term Partnerships Matter

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

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.

Batch Certification for New Manufacturing Technologies: The Qualified Person Role in a Digital Environment

As advanced manufacturing technologies reshape pharmaceutical production, the Qualified Person (QPs) must evolve from a traditional document reviewer into a digitally fluent leader capable of navigating complex data ecosystems, real-time analytics, and automated control systems. This article presents a holistic framework for “Certification by Design,” highlighting how QPs can ensure compliant, agile, and science-based batch release in the era of Industry 4.0.

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.

Strengthening Sustainability Through Smarter Ingredients: Designing Resource‑Efficient Formulations

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

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.

How Biologic Developers Use Optimized Platforms and Operations to Reach First-in-Human Trials

Emily Schirmer, Catalent, explains how to accelerate the path to first-in-human trials as biologics pipelines grow more complex and timelines tighten.

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.

Eli Lilly Introduces Multi-Dose Zepbound KwikPen to Expand Obesity Treatment Options

The multi-dose pen, designed to deliver a full month’s supply, could help alleviate device supply limitations and influence future distribution strategies.

Digital Transformation in Pharmaceutical Manufacturing

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

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.

Viral Safety 2.0: Plant-Ready Actions for ICH Q5A(R2) Compliance

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

CPHI Americas: The Business Case for Product Carbon Footprints in Pharma

Pharmaceutical suppliers face growing pressure to calculate product carbon footprints as customer requirements and global regulations tighten.

Improving AAV Vector Quality with In-Process Monitoring of Capsid Formation

CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

The Roadmap to Asset Performance Management in Life Science

A Risk-Based Framework for Excipient Development

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

Reducing Risk in Small Molecule Development: Choosing the Right CDMO Partner

Terry Novak, CEO of Benuvia, explores how pharmaceutical and biotech companies can mitigate development risks and accelerate speed-to-market by prioritizing technical alignment, robust project management, and early-stage collaboration with the right CDMO partner.

Co-Processed Excipients: Practical Engineered Solutions for Modern Pharmaceutical Challenges

This article details what co-processed excipients are and how they are made.

HME vs Spray Drying: A Comparison of Saturated Solubility Enhancement

Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.

Excipient Selection Strategies to Mitigate Nitrosamine Risks

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

ICH Q6B for Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

Optimizing Testing in Cell and Gene Therapy: A Key Driver for Industry Growth and Adoption

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery Formulations

The growing demand for liquid medicines is increasingly driven by the unique needs of several distinct patient groups, improving compliance in these demographics through flexible, palatable dosing options.

The Only Solution to Thoroughly and Consistently Blend Difficult-to-Mix Powders in Pharmaceutical Production

One of the biggest challenges in pharma production is cohesive, incompatible, or otherwise difficult-to-mix powders. Luckily, mixing technology is advancing and innovative solutions exist to overcome nearly all challenges.