Authors

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.

From Retrospective Testing to Continuous Process Intelligence

As biopharmaceutical manufacturing becomes increasingly automated, real-time analytical data is poised to transform how manufacturers monitor processes, make decisions, and optimize production. Bryan Hassell, founder and CEO of Nirrin Technologies, discusses why trusted, continuous measurements will be essential to the next generation of digital biomanufacturing.

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.

An Innovative, Modular Approach to Flexible Supply Chain Management

See how early supply chain engagement and continuous improvement reduce risk, accelerate tech transfer and time-to-market, and ensure reliable supply for customers and patients—download the white paper to learn more.

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.

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.

The Switch to Cell-Free DNA: Strategic and Regulatory Considerations for Advanced Therapies

Webinar Date/Time: Thu, Dec 11, 2025 11:00 AM EST

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.

Bringing Scalability to Metabolic Flux Analysis using Machine Learning to Accelerate LC-MS Interpretation

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

How Modularization and Digital Delivery are Transforming Pharma Manufacturing

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

The authors propose a streamlined, efficient approach to determining specification equivalence that starts with a paper-based assessment of the methods and progresses to a data assessment for the methods under evaluation.

From Lab Through Launch

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.

Sartorius Launches Rational-Design CHO Host Cell Line Delivering Up to Three-Fold Productivity Gains

A newly engineered CHO host from Sartorius, developed through proteomic profiling and targeted genome editing, demonstrates up to three-fold productivity increases and accelerated nine-week cell line development timelines, supporting more stable, high-titer biomanufacturing for biologics and biosimilars.

Continued Process Verification Is Critical in Pharmaceutical Manufacturing

Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

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.

Best Practices for Secure Disposal of Controlled Substance Pharmaceuticals

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.

CRISPR Gene-Editing Technology in the Development of Biopharmaceuticals

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

Digital Standards Aim to Modernize Quality Assurance Without Compromising Confidence

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.