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Emily Null

Emily Null, MS, is a scientist with Steris Corp.

Latest Article

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Alan Xu

Alan Xu is product manager, analytical services at Stevanato Group.

Latest Article

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Robert Brousseau, Senior Content Manager, SK pharmteco
Robert Brousseau, Senior Content Manager, SK pharmteco
Latest Article

How the Nitrosamine Guidance Shift is Changing LC-MS Workflows for APIs and Peptides

For chromatography and mass spectrometry groups, the most important recent change in the nitrosamine field is not simply that the limits got tighter.1-3 It is that the analytical target has become less generic. The field has moved away from a narrow focus on a short list of classic, small nitrosamines and toward API-specific nitrosamines, nitrosamine drug substance-related impurities, packaging-linked risks, and matrix-dependent confirmation problems. This change has direct consequences for how methods are selected, developed, and validated.1-3,8

Piet Christiaens

Piet Christiaens is scientific director at Nelson Labs Europe.

Latest Article

Extractable and Leachable Challenges in Lyophilized Drug Products

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Fresenius Kabi
Latest Article

Fresenius Kabi Contract Manufacturing: Focused on Your Success

Saleem Farooqui of Fresenius Kabi explains how the company is addressing today’s pharmaceutical manufacturing needs. Watch this video to learn how these capabilities can help bring products to market successfully.

Lyn McNeill

Lyn McNeill is Just in Time Manufacturing Solutions manager at Almac Clinical Services.

Latest Article

Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access Programs

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

Mildred R. Bernardo

Mildred R. Bernardo is lead scientist with Steris Corp.

Latest Article

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Florian Schindler

Florian Schindler is head of Business Development, ACTEGA GmbH.

Latest Article

Sustainable Alternative: PFAS-Free-TPE for Pharmaceutical Stoppers

Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more sustainable product.

Cecilia Pierobon
Cecilia Pierobon

Cecilia Pierobon is manager with Life Sciences Technical Services, STERIS.

Latest Article

Assessment of Silicone Oil Cleaning on Indirect Surfaces in Aseptic Manufacturing

This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.

Altair
Latest Article

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

Fedegari
Latest Article

Fedegari’s FOB5 Redefines Sterilization with Compact Design and Full GMP Compliance

Discover how Fedegari’s FOB5 is redefining sterilization with compact design, GMP compliance & high-containment capabilities.

Brian Drapeau
Brian Drapeau

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.
He can be contacted at bdrapeau@gxpframe.com for any consulting or advisory needs. 

Latest Article

Drapeau’s AI Deep Dive: The Control Lab Tested for Flavor

Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.

Tim Stroud
Tim Stroud

Tim Stroud is Solutions Consultant Team Leader at Cenevo. He is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo, he worked as a scientist and lab automation specialist in the pharmaceutical industry at Pfizer and AstraZeneca. He leads Cenevo's team of solutions consultants, who deliver expert support to the sales teams in providing laboratory automation and software solutions to our clients in the academic, biotech, pharma, hospital, and agriscience sectors. www.cenevo.com

Latest Article

It’s Time to Build a More Scalable, Connected CRO

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

Nathan Edwards, PhD

Nathan Edwards, PhD, specializes in business development, new product planning, and early brand strategy. He helps companies lay the foundation for successful launches through data-backed strategies spanning indication assessment to portfolio strategy. With a strong background in pricing and market access, Nathan integrates both commercial and access insights into early asset development to maximize market opportunity.

Latest Article

Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

Austin Px
Latest Article

Collaboration and Innovation are at the Heart of AustinPx’s ASD Workshop

The biannual AustinPx Amorphous Solid Dispersions (ASD) Workshop is a place for collaboration and innovation. Hear firsthand from attendees about challenges and insights from the front lines of amorphous drug development.

Thomas Ybert

Dr. Thomas Ybert is chief scientific officer and co-founder of DNA Script and leads the company's research and innovation efforts. Thomas is the main inventor of DNA Script's Enzymatic DNASynthesis (EDS) technology. Holding a PhD in molecular biology and yeast genetics from Ecole Polytechnique, his background includes R&D roles at Sanofi and Total/Amyris.

Latest Article

Writing the Biological Script: Scaling DNA Manufacturing for the Next Generation of Therapeutics

The future of synthetic biology will depend not only on the ability to design biological systems, but on the capacity to manufacture DNA reliably at scale within regulated frameworks.

Contract Pharmaceuticals Limited (CPL)
Latest Article

A Discussion: In Vitro Release Testing and Its Application and Use in Generic Topical

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.

Mike Schaefers

Mike Schaefers is chief commercial officer at Simtra BioPharma Solutions.

Latest Article

How CDMO Alliances Can Provide End-to-End Service that Reduces Drug Development Time and Costs

Integrated CDMO networks streamline complex drug development across advanced modalities like ADCs.

Angeline Dhas

Angeline Dhas is an AI Product Specialist for MadeAi.

Latest Article

Accelerating HTA Readiness with Generative AI

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

Margaret Radford

Margaret Radford is unlicensed medicine services manager at Almac Clinical Services.

Latest Article

Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access Programs

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

Mandy Vink
Latest Article

How Codexis is Redefining Pharma Biocatalysis

Mandy Vink, VP of Business Development at Codexis, explains how the company leverages over 20 years of expertise in small molecule APIs to advance biocatalysis across pharma.

Ecolab Life Sciences
Latest Article

Integrated Contamination Control Solutions for Biopharma

Program overview brochure for Ecolab’s Biopharma offering

Sharon Flank

Sharon Flank, PhD, sflank@infratrac.com, is CEO at InfraTrac.

Latest Article

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.

Lonza Capsules & Health Ingredients
Latest Article

Inside Lonza CHI’s Innovation Strategy: Future-Ready Capsules for Complex Drugs

How Lonza Capsules & Health Ingredients (CHI) is redefining drug delivery with cutting-edge capsule innovation, customer-first service, and a strong commitment to sustainability

Fernanda Onofre

Fernanda Onofre is global marketing director, Pharma Excipients, HNC at dsm-firmenich.

Latest Article

The Role of Flavoring Agents and Taste Modulation Strategies in Drug Development

This article investigates the role of flavoring agents and taste modulation strategies and describes how these solutions can help to mask unpleasant tastes, improve palatability, and, ultimately, increase patient compliance to drive better treatment outcomes.

Richard K. Burdick

Richard K. Burdick is principal of Burdick Statistical Consulting and Professor Emeritus of Statistics at Arizona State University.

Latest Article

Comparability in Accelerated or Stressed Stability Studies Using a Quality Range

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

Matt Cushing

Matt Cushing, VP of Quality and Science, Nelson Labs

Latest Article

Guidance on Quality Culture Standards

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Mike Hennessy Jr.

Mike Hennessy Jr. is the Chairman and CEO of MJH Life Sciences.

Latest Article

Proving Control, Not Assuming It

The articles in the September/October 2026 issue of PharmTech show that control must be designed in, verified, and documented at every step.

Charlotte McIlvaine

Charlotte McIlvaine is senior manager-North America Pharma Quality at Univar Solutions. Charlotte is an analytical chemist experienced in quality control and quality assurance. Charlotte joined Univar Solutions over 9 years ago to oversee quality in 2 districts focusing on the quality needs for Univar Solutions’ pharmaceutical customers.

Latest Article

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.

Michelle Heiter

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Latest Article

Effectively Using Contamination Control Strategies

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.