Authors

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.

Audits, Inspections, and CDMOs

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.

Regulatory Actions Impacting Biologics

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

The Push for Momentum, Not Mistakes in Orphan Drug Development

This article outlines common CMC problems that are obstacles that steal momentum and create costly detours in the development or orphan drugs.

Why Pharma’s AI Agents Need Smaller, Domain-Specific Models First

Large-language models are excellent for general-use AI systems, but they don’t understand pharmaceutical companies’ proprietary documentation—the validated procedures and quality protocols that ensure drug safety. Smaller, domain-specific language models give companies more control and efficiency in their AI use.

How Codexis is Transforming RNA Manufacturing

Britton Jimenez, SVP of Sales and Marketing at Codexis, explains how the ECO Synthesis® Manufacturing Platform overcomes the limitations in scalability and sustainability that currently challenge the RNA therapeutics industry.

Focusing on the Fundamentals of Formulation

This article previews some formulation topics discussed in the Pharma Fundamentals series, which aims to enhance learning for professionals in pharmaceutical drug development and manufacturing.

Orally Dissolving Films: A Modern Solution for Convenient Drug Delivery

The aim of this study was to develop and optimize an orally dissolving film formulation containing a blend of active ingredients in a strategic combination of natural and synthetic excipients to achieve a balance between controlled actives release and rapid onset of action.

Multi-Compendial Compliance for Pharmaceutical Excipients–Part 2: A Detailed Assessment for Specification Equivalence

This paper provides a technical assessment of compendial tests commonly found in the European Pharmacopoeia, the United States Pharmacopeia–National Formulary, and the Japanese Pharmacopoeia, detailing differences between the methods and acceptance criteria, and the potential impact of these differences on multi-compendial compliance.

Nasal Delivery of Spray Dried Biologics: Opportunities & Challenges

Automate Aseptic Filling: Closing the System at Full Modularity

Shifting to automated, closed modular manufacturing systems is growing increasingly crucial for biopharmaceutical production.

Thermo Fisher's Kane Says AI Is Reshaping How CDMOs Add Value

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner.

What Trutakna's FDA Approval Means for Specialty Biologics

FDA approves a new IgA nephropathy therapy that targets two immune cytokines at once, offering a weekly, self-administered treatment option.

The Role of Continuous Monitoring Systems in Meeting Regulatory Requirements

An educational eBook exploring how continuous environmental monitoring systems help pharmaceutical and biopharmaceutical manufacturers achieve and maintain FDA, GMP, and 21 CFR Part 11 compliance.

Is Pharma Solving the Right Problem with its Data Transformation Efforts?

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An industry podcast brought together life sciences thought leaders to debate the subject. The panelists noted that really, by now, standardized data should be yielding greater intelligence, and powering pharma’s future, accelerated by AI. If only companies could find new momentum to finally sort out their underlying data. This article sets out some of the key points that arose from the panel.

Why PROCIPIENT® Sets the Standard for the Critical Role of High Purity Solvents in Complex Drug Delivery Systems!

In this interview, Rishi Pimentel of gChem explains how PROCIPIENT®, a cGMP-compliant excipient-grade DMSO, supports advanced therapies with superior purity and sterility, mitigates risks of using industrial-grade solvents, and strengthens regulatory readiness and supply chain security.

A Capsule-in-Capsule Platform for Multi-Phase Release of Liquid and Solid Formulations

A dual delivery capsule platform provides delivery of multiple APIs with a single dosage unit, which reduces pill burden and simplifies dosing regimens.

What’s Reasonable to Expect from Agentic AI in Pharma? Part Three: Tapping Agentic AI’s Potential

In the conclusion of this three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

Adding SYLOID® Mesoporous Silica to Improve Run Time and Yield for Micronization Processes

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.

Transforming Downstream Purification: Trends Shaping the Future of Biologics Manufacturing

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

Johnson & Johnson’s Tecvayli Combo Wins FDA National Priority Voucher

The FDA Commissioner’s National Priority Voucher pilot program has added J&J’s Tecvayli as the latest voucher recipient.

Overcoming Drug Interference in an IND-Track ADA Assay

Learn how a custom ADA assay was designed, incorporating acid dissociation with the ACE method to overcome drug interference using other standardized formats.

Manufacturer Guidelines for the Secure Destruction of Controlled Substance Pharmaceuticals

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional Findings, and Documentation System Evaluation

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

Executive Summary: Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Inhaled Product Design and Development

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.

Molecular Properties of PROTACs and the Relationship to Formulation Design

Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.

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.

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.