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Authors

Yeli Zhang

Yeli Zhang, PhD, is Application and Innovation Technical Service Manager, Roquette.

Latest Article

Selecting the Right Drug Delivery Formulations to Enhance Patient-Centric Care

A growing demand for liquid medicines is driven by patient groups' unique needs, improving compliance through flexible and palatable dosing options.

Lyufei Chen

Lyufei Chen, PhD, is an application scientist at HORIBA Scientific.

Latest Article

A-TEEM: A Novel, Powerful Tool for Evaluating and Monitoring Cell Culture Media

Fluorescence spectroscopy with A-TEEM offers rapid, precise monitoring of cell culture media variability for improved biopharmaceutical quality control.

Anshul Mangal

Anshul Mangal is CEO of Project Farma and president of PerkinElmer OneSource.

Latest Article

Building Robust Biomanufacturing Networks for the Next Wave of Therapies

Biomanufacturing is shifting toward more resilient and digitized networks for enhanced supply security amid global and supply-chain volatility.

Mike Hennessy Jr.

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

Latest Article

Advancing Precision and Agility in the Era of Complex Biologics

Precision analytics and flexible manufacturing are helping to advance safer, scalable bispecific antibodies, antibody-drug conjugates, and central nervous system monoclonal antibodies from development to patients.

Laura Kronbetter

Laura Kronbetter is a Senior Global Product Manager at Bio-Rad Laboratories. She is a dedicated marketing professional in the life sciences industries with focused knowledge in managing and supporting process chromatography products used for the purification of biomolecules. With more than 20 years of experience in the industry and product management, Laura is passionate about developing and launching innovative products that meet customers' needs. She holds a bachelor's degree in biochemistry from Purdue University.

Latest Article

Optimizing Downstream Processes for Biotherapeutic Development with Prepacked Chromatography Columns

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

Stefan-Julian Frohberger

Stefan-Julian Frohberger is senior microbiologist at Ecolab Life Sciences.

Latest Article

Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part II. Biopharmaceutical Non-Sterile Equipment Cleaning

This second part of a two-part article provides a clear understanding of microbiological load reduction during cleaning processes in the non-sterile pharmaceutical manufacturing.

Jay Harkins

Jay Harkins is senior product manager at DWK Life Sciences LLC, Millville, NJ.

Latest Article

Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure Systems

This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.

Melanie Cerullo

Melanie Cerullo is chief quality officer at Kindeva.

Latest Article

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.

Christophe Dufossé

Christophe Dufossé is senior strategic marketing manager Next-Gen Bioprocessing, Merck KGaA, Darmstadt, Germany.

Latest Article

A Step Closer to Closure in Bioprocessing

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

Conor Barry, PhD
Latest Article

Advancing ADC Manufacturing and Supply Chain Solutions

Conor Barry, PhD, Vice President and Global Head of R&D for Bioconjugates and Large Molecules at Piramal Pharma Solutions, discusses the evolving antibody-drug conjugate (ADC) landscape and how the company’s strategic investments and ADCelerate program are simplifying complex supply chains for global partners.

Greg Swan

Greg Swan is business development manager, cell & gene therapies, at Avantor.

Latest Article

Improving Vector Yield at Scale: A Fresh Approach to Cell Lysis Quality Assessment

Optimizing the harvest of viral particles is important for the yield and purity of the final product.

Bill Holt

Bill Holt, DO, is vice president, Neuroscience Therapeutic Area, at ICON.

Latest Article

Clinical Success for CNS mAbs Depends on More Than Mechanisms of Action Alone

CNS monoclonal antibody therapies demand rigorous screening and monitoring to ensure patient safety in MS, NMOSD, and Alzheimer disease.

Ron Panarotti
Latest Article

Addressing Manufacturing and Access Barriers in Advanced Therapeutics

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Vasileios Toxavidis

Vasileios Toxavidis is senior solutions product manager at Beckman Coulter Life Sciences.

Latest Article

Advancing Precision Cell Analysis: The New Era of Spectral Flow Cytometry

Spectral flow cytometry is democratizing high-parameter cell analysis, using modular instruments and AI to unlock deeper insights in cancer research.

Paul Romness
Paul Romness

Paul Romness, MHP, is chair and CEO of OS Therapies, a company developing novel immunotherapies for cancers like osteosarcoma and other solid tumors.

Latest Article

How Linker Innovation Could Shape the Next Generation of Antibody–Drug Conjugates

Paul Romness, chair, chief executive officer, and president of OS Therapies, discusses how advances in linker chemistry, payload design, and evolving regulatory approaches could shape the next generation of antibody–drug conjugates for oncology.

John Tomtishen

John Tomtishen is senior vice-president and general manager (IDMO Business), Cellares.

Latest Article

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.

Stefan Foser

Stefan Foser is VP Global Pharma at Bruker Daltonics.

Latest Article

Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Evonik
Latest Article

Ensuring the highest purity in injectable formulations with MaxiPure® Polysorbate 80

MaxiPure® Polysorbate 80 is a highly pure excipient designed for high-value injectable applications where control of particles, oxidative stress, and biological compatibility is essential. Fully compliant with Ph. Eur., USP-NF, JP and CP monographs, this non-ionic surfactant is characterized by an oleic acid content above 98%, exceptionally low impurity levels, and outstanding clarity. By combining regulatory excellence with functional performance, MaxiPure® Polysorbate 80 supports the development of stable and safe protein-based therapeutics, and ensures formulation reliability across the drug development lifecycle.

Carrie Bracco
Carrie Bracco

Carrie Bracco is head of business development, US, at Novartis Contract Manufacturing

Latest Article

Ask the Expert: Manufacturing Flexibility Is the Next Competitive Advantage

Carrie Bracco, head of business development, US, Novartis Contract Manufacturing, explains why manufacturing flexibility is becoming as important as capacity for emerging biotechnology companies navigating biopharmaceutical development and contract manufacturing decisions.

Codexis
Latest Article

Inside Codexis: 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.

Yasmin Timol

Yasmin Timol is project manager and market researcher at BioPlan Associates.

Latest Article

Outsourcing Hits Record Levels for All Bioprocess Platforms

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

Erik Wiklund
Erik Wiklund

Erik Digman Wiklund is CEO of Circio. He has deep scientific knowledge in RNA and cancer biology and 13 years of pharma and biotech industry experience in a variety of functions including R&D, finance and business development. Wiklund holds a PhD in molecular biology from Aarhus University in Denmark and the Garvan Institute of Medical Research in Sydney, Australia.

Latest Article

Circio CEO Highlights Circular RNA Potential for Safer, More Efficient Gene Therapy

Circio CEO Erik Wiklund discussed how circular RNA technology may improve the safety, durability, and cost-efficiency of AAV gene therapies for cardiovascular diseases at ASGCT 2026. Early animal data suggest the platform reduces cellular stress responses while increasing gene expression, potentially expanding access to safer and more scalable gene therapy treatments.

Dario Zagallo

Dario Zagallo is SME Study Monitor - EMEA Technology Excellence Center (TEC) Analytics at Stevanato Group.

Latest Article

Mechanical Robustness of 2R Glass Vials Across Fill/Finish Operations: Implications for Biopharma Manufacturing

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

Georgia Sloboda

Georgia Sloboda is managing director of Chemistry Manufacturing and Controls, Sia/LBG.

Latest Article

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.

Nicholas Jacobus
Latest Article

Ask the Expert: Manufacturing Flexibility Is the Next Competitive Advantage

Carrie Bracco, head of business development, US, Novartis Contract Manufacturing, explains why manufacturing flexibility is becoming as important as capacity for emerging biotechnology companies navigating biopharmaceutical development and contract manufacturing decisions.

Chris Chen

Chris Chen is the CEO of WuXi Biologics. Dr Chen served on the International Board of Directors for ISPE and holds a PhD in Chemical Engineering from the University of Delaware.

Latest Article

Single-Use Technology: Transforming Biomanufacturing Today and Tomorrow

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

Fei Chen

Fei Chen, PhD, is head, Cell Line Development, at WuXi Biologics.

Latest Article

Developing Next-Gen Cell Lines Using Targeted Integration

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Israel Ortíz

Israel Ortíz is vice president and general manager at Accruent.

Latest Article

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Vibha Jawa
Vibha Jawa

Dr. Vibha Jawa is Chief Scientific Officer at EpiVax, where she leads scientific strategy and innovation in immunogenicity and translational science. Previously, she held leadership roles at Bristol Myers Squibb, Merck, and Amgen, supporting biologics, vaccines, and cell and gene therapy development. With more than 20 years of industry experience, she has contributed to more than 20 IND, BLA, and MAA filings. Jawa has authored more than 75 peer-reviewed publications and serves in multiple leadership roles within AAPS and other scientific organizations. She was named an AAPS Fellow in 2022.

Latest Article

Ask the Expert: Rethinking Preclinical Development Through Predictive Models and Human-Relevant Data

Advances in predictive modeling, translational bioanalytics, and human-relevant research systems may help reduce reliance on animal testing while improving the clinical relevance of preclinical drug development. Experts say these approaches could streamline IND preparation, lower costs, and support more informed decision-making across biopharmaceutical R&D.

Venkat Reddy Sunkara

Venkat Reddy Sunkara is Global Head, Regulatory Affairs and CMC at ICON.

Latest Article

Formulation Strategies, Tech Advances, Challenges, and Considerations in Novel Drug Delivery

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.