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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.

Ecopipam's D1 Receptor Approach Signals New Pediatric Neuroscience Pathway

FDA grants Priority Review to Teva's ecopipam new drug application, backed by phase 3 data. Ecopipam is a first-in-class D1 receptor therapy for pediatric Tourette syndrome.

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

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

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.

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

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.

Leveraging 3DP In-Blister Tech for Real Time Release

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet 3D-printing enables advanced process analytics, tablet-level traceability, and continuous monitoring to provide a data-driven approach to pharmaceutical production. By measuring critical quality attributes for every tablet throughout manufacturing, the platform enables continuous process verification, targeted identification of deviations, and reduced waste compared with traditional batch-based quality methods. This integrated foundation supports real-time release while delivering greater transparency, process control, and operational efficiency across the product lifecycle.

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.

Digital Standards Aim to Modernize Quality Assurance Without Compromising Confidence

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

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.

Using Automation to Enhance Pharmaceutical Manufacturing

The future factory will be defined by how well automation tools work together with people, processes, and quality systems to make pharmaceutical manufacturing faster, smarter, more transparent, and more reliable.

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.

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.

The AI-Synchronized CMO: A 2026 Mandate for Collapsing Onboarding Timelines and Orchestrating Operational Excellence in a Geopolitical Minefield

A framework for 2026 that moves beyond manual AI onboarding toward "zero-lag" integration for pharmaceutical manufacturing.

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.

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

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

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

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