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Executive Summary: Commercial Tech Transfers in OSD Manufacturing

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

Pharma Fundamentals: Risks and Regulations for Hold Times in Biopharmaceuticals

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

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.

Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.

The Benefits of SaaS for Laboratory Informatics

LabVantage is advancing software as a service (SaaS) for the laboratory information management system (LIMS) market to provide laboratories with reduced costs and pre-validated solutions that facilitate scalability and faster speed-to-market for pharmaceuticals

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.

PharmTech AI Pulse Check: Why Pharma Should Weigh In on FDA's Generative AI Paper

The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.

Reimagining Signal Management: How Autonomous Pharmacovigilance Could Render Reporting Timelines a Thing of the Past

Attention around pharmacovigilance transformation potential has tended to focus on automating discrete steps in the case-processing pipeline. End-to-end ICSR autonomy may enable near-instantaneous case processing so that current SUSAR targets become obsolete.

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.

Rare Disease Therapies: How Orphan Drugs Are Reshaping Global Biopharma Sourcing

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

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.

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

A dual-delivery capsule platform delivers multiple APIs in a single dosage unit, reducing pill burden and simplifying dosing regimens.

Optimizing Impact for Rare Diseases

Treatment pipelines for rare diseases have never been more promising. Optimizing their impact will require integrated, precision-first CDMO support systems.

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

SK pharmteco’s Three-Business-Unit Strategy: Small Molecules, Peptides, and Viral Vectors

Joerg Ahlgrimm, CEO of SK pharmteco, outlines the company's strategic expansion into cell and gene therapy. He also details their commitment to global operational excellence and a culture of employee purpose.

Streamlined Product Development Leveraging Pharmaceutical Classification Models

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.

Power of Two One-Sided Tests with Unequal Variances

Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.

Ensuring the Supply Chain through Purchasing Controls

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

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Strategies to Maximize Stability of Emerging Biologics

As the biologic pipeline diversifies across ADCs, bispecific antibodies, and fusion proteins, formulation science has become the critical discipline bridging molecular complexity and patient-ready therapy.

Is Your Annex 1 Strategy a Static Document or a Dynamic Defense?

Contract development and manufacturing organizations can assist the sponsor company in ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

Strengthening Sustainability Through Smarter Ingredients: Designing Resource‑Efficient Formulations

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

Making Critical Therapies More Accessible with Nasal Sprays

Drug Digest: How Advanced Analytics Partnerships Enhance the Biopharma Value Chain

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

Sustainability by Design: Re-Imagining Amorphous Dispersion Manufacturing

A comprehensive approach to long-term sustainability efforts in pharmaceutical manufacturing should prioritize simpler frameworks that curb costs, risks, and variability.

How Innovation Is Reshaping Outsourced Development and Manufacturing

Innovators are increasingly focused on whether outsourced partners can help them make better decisions earlier, before uncertainty becomes late-stage risk.

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.