Authors

How Can AI Help Cancer Practices Improve Care and Clinical Research?

Eron Kelly, CEO of ConcertAI, and Dr. Shaalan Beg, CMO, oncology, ConcertAI, discuss how AI can help physicians access the right information at the right time while supporting clinical trials, research, and quality initiatives.

Q&A with Dr. Jack Prior: Is Your Process Data Ready to Act On?

Sanofi’s Jack Prior discusses how biopharmaceutical manufacturers can assess whether process data is ready for human and AI use, and the role of data quality, accessibility, governance, and AI in manufacturing.

Securing 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.

Viral Safety 2.0: Plant-Ready Actions for ICH Q5A(R2) Compliance

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

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.

Helping you navigate the evolving antibody therapeutic landscape

The Evolving Cost-Benefit Landscape of Biosimilar Drug Development

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.

Developing Next-Gen Cell Lines Using Targeted Integration

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

Developing Next-Gen Cell Lines Using Targeted Integration

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

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.

What It Takes to Support Emerging Biopharma Programs Through Rapid Candidate Identification

Success in emerging biopharma depends not only on speed, but also on making confident, data-informed decisions early in development while managing increasing molecular complexity.

The Importance of Innovation in Mission-Critical BioPharma Cold Storage

Precise cold chain management is essential to safeguard biologics, but traditional ULT freezers can’t keep pace with the demands of modern drug development.

Choosing the Right CDMO for Long-Term Stability

Dr. Patrick Meyer, Global Head of Business Development at Rentschler Biopharma, outlines the deciding factors biotechs should consider when selecting a contract development and manufacturing organization (CDMO) partner.

Develop Your Biologic with Technology, Process Strategy, and Market Strategy in Mind

Biopharmaceutical manufacturers can strategically choose between fed-batch and continuous manufacturing to balance scalability, flexibility, and market demand across the product lifecycle.

IPEC’s EIP: 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.

Why AI Alone Won’t Transform Bioprocess Manufacturing

Real-time process analytics and digital manufacturing systems could generate the reliable data needed for artificial intelligence to deliver more predictive insights in biopharmaceutical manufacturing, according to Bryan Hassell, founder and CEO of Nirrin Technologies.

How Patient-Derived Models and Advanced Imaging Systems Are Shaping Next-Gen Immunotherapies

CGT is rapidly transforming oncology and rare disease research, with patient-derived models, advanced imaging, CRISPR/Cas9, and 3D organoids driving innovation while solid tumor modeling remains a critical frontier.

Optimizing Testing in Cell and Gene Therapy

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

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.

Accelerating and Streamlining Microbial Process Development With a Novel Technology (Sept 2026)

This executive summary examines how FUJIFILM Biotechnologies' ShunzymeX™ platform addresses the purification challenges that make microbial expression systems slower and less predictable than monoclonal antibody workflows. Andrei Soliakov, PhD, a principal technical project lead of process development at FUJIFILM Biotechnologies, details the engineering of a scarless protease developed in partnership with the University of Edinburgh, along with proof-of-concept results across four structurally diverse model proteins. Readers will see how a standardized downstream workflow shortens the path from expression strain to GMP manufacturing.

What FDA's AI Warning Letter Tells Us About GMP Accountability

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

inSPECt™ MS – Global HCP Profiling and Quantification by Native Digestion and LC-MS Analysis

CGT Diagnostic Testing Partners Require Pioneering Spirit in Rapidly Evolving Landscape

The growing cell and gene therapy (CGT) market is driving demand for innovative, robust diagnostics to meet scaling, regulatory, and quality needs.

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.

Supply Chain Execution in Radiopharma: The Industry’s Next Critical Challenge

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss the operational and logistical challenges shaping the radiopharmaceutical sector as therapies move toward broader commercialization. The executives outline how regulatory complexity, short delivery windows, AI-enabled logistics systems, and global coordination requirements are redefining advanced therapy supply chains.

Accelerate Next-Generation Bioconjugate Development through an Innovative Technology Platform

The path to ADC success demands precision – from DAR optimization and linker stability to rigorous safety profiling! Discover how novel conjugation and payload-linker platform empowers the rational design of next-generation ADCs with enhanced therapeutic potential —improving efficacy, stability and safety.

Q&A: Biopharma Deal Strategy Shifts Toward Risk Management

Sebastian Andersen, CEO and founder of ClarityNorth Partners, discusses H1 2026 biopharma M&A, oncology deal activity, Lilly’s strategy, capital deployment, and how transaction structure can help companies manage risk.

Immunocore's Dar Says TCR Therapies Could Broaden Immunotherapy Beyond Checkpoint Resistance

Updated clinical findings for brenetafusp highlight how T-cell receptor bispecific therapies may overcome key mechanisms of checkpoint inhibitor resistance while expanding immunotherapy to a broader range of solid tumors.

Investigating Bioreactor Contamination, Modeling Contaminant Introduction, and Ensuring Bioburden Test Reliability

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

AI, Global Collaboration, and Investment Are Poised to Shape Biopharma's Future, Says Sara Jane Demy

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy, CEO of Demy-Colton, discusses how artificial intelligence, global collaboration, and renewed investment could help improve drug development success rates and accelerate innovation.