The articles in this issue reflect an industry in transition, committed to innovation while ensuring safe, reliable, and forward-looking pharmaceutical production.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing.

Counterfeit pharmaceuticals jeopardize public health worldwide, often leading to ineffective or dangerous treatments. Enter Raman spectroscopy: a rapid, non-destructive analytical technique that unveils the molecular secrets of medications. With its ability to identify counterfeit drugs through unique molecular fingerprints—even without unsealing their packaging—this technology is transforming pharmaceutical forensics and safeguarding global health.

Digital transformation, AI, 3D printing, and proactive maintenance are reshaping pharma, speeding discovery and demanding new manufacturing standards.

Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability.

Though not an actual creature, the aptly named longevity fund has announced a strategic investment in Etheros’ development of a new class of drugs.

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.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.

Starting with risk mitigation, GMP facility and equipment maintenance is all about anticipating problems before they happen and showing regulators a controlled environment.

Live cell phenotypic screening can enhance translational predictability and speed up lead optimization.

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.

The first patient visit has taken place for the SURMOUNT-REAL UK clinical trial of Eli Lilly and Company’s weight-loss drug, tirzepatide.

3D printing enables personalized precise drug delivery, enhances compounding efficiency, and is driving new regulatory models like distributed pharmaceutical manufacturing.

With big moves and investments being made via pharma outsourcing, it’s important for industry professionals to stay on top of trends and innovations.

AI transforms formulation, bioanalysis, and manufacturing; accelerated FDA reviews demand parallel development readiness; new nasal spray enhances patient drug access.

While the deadline to make oral presentations has passed, public comment can be submitted up to a month after the workshop is held on Dec. 16.

Five experts in the bio/pharmaceutical industry explore the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

Machine learning tools are now moving from concept to validated applications, driving transformative shifts in bioanalysis, preclinical testing, and formulation optimization across the industry.

Five bio/pharmaceutical industry experts discuss the impacts of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

AI, in-silico modeling, and rational design streamline drug formulation; rapid regulatory pathways demand pre-submission perfection in quality and parallel execution.

Industry experts weigh in on the CNPV's demands for flawless CMC pre-submission, affordable pricing, expanded communication, and more.

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.

The conclusion of this interview with Sanjay Konagurthu focuses on simulations and calculations that go beyond simple screening.

FDA’s CNPV pilot aims to speed drug reviews but raises questions about safety trade-offs, resource strain, and unclear incentives for sponsors.

Sanjay Konagurthu of Thermo Fisher Scientific discusses how AI and ML can help solve the dilemma of poor solubility.

To meet rising demand, developers of precision radiopharmaceutical therapies must overcome challenges in global isotope supply and align R&D platforms with evolving FDA guidance on clinical dosimetry.

The European Union aims to become the most attractive destination for clinical research.