Authors

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.

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.

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.

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.

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.

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.

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.

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.

Analytics, Automation, and Quality Driving the Next Era of Drug Development

Each step of development and manufacturing is becoming more interconnected, and BioPharm's September/October issue highlights the strategies, tools, and innovations shaping the future of the field.

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.

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.

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.

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.

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.

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.