Authors

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.

Fresenius Kabi Contract Manufacturing Focuses 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.

How Modularization and Digital Delivery are Transforming Pharma Manufacturing

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

Addressing manufacturing at scale for ATMP’s

Addressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.

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.

Axial Compression Column Packing at Process-Scale: Resin Compressibility Insights and Considerations

Webinar Date/Time: Tue, Oct 14, 2025 10:00 AM EDT

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.

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.

Enhancing CDMO Capabilities to Meet Evolving Client Needs

Rentschler Biopharma is evolving its CDMO capabilities through strategic partnerships, infrastructure investments, and sustainability initiatives to better support clients' complex biologics programs.

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.

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.

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.

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.

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.

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.

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.

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.