Authors

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.

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.

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.

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

The Roadmap to Asset Performance Management in Life Science

How Regulatory Oversight Protects CBD Consumers

Many consumers trust that a Certificate of Analysis (COA) guarantees product safety, but without strict regulatory oversight, that’s not always the case. This white paper provides insights into what consumers and businesses should look for in a truly safe, high-quality, and consistent product.

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.

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.

New Possibilities in Pharmaceutical Processing with RAM Technology

Webinar Date/Time: Wed, Oct 8, 2025 11:00 AM EDT

Understanding the Variability in Bioburden Test Results in Biomanufacturing

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

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.

ICH Q6B for Analytics

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

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Microplastics as Vectors of Pharmaceuticals in Ecosystem: A Concern

While plastics have revolutionized pharmaceutical packaging, that evolution within the industry has come at a cost.

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.

Industry Outlook 2025: European Political Impacts on the Supply Chain

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.