Authors


Roland Ashton

Latest:

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

Traditional project decision-making vs. a QbD approach.


Julia Olsen-Claire

Latest:

Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and Management

A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.


Erkki Goodwin, CAPM

Latest:

Outsourced Training: A Primer

Five key attributes to look for in a biopharm training partner.


Claire Scanlan

Latest:

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.


Daniel Baur

Latest:

Increasing Capacity Utilization in Protein A Chromatography

A twin-column periodic countercurrent capture process that combines an efficient sequential, countercurrent loading process with a minimal twin-column hardware configuration is described.



Antoinette Konski

Latest:

New Gene Patent Rules

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders


Phil Kaminsky

Latest:

Optimizing Global Biopharmaceutical Operations Through Risk Mitigation and Management

A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.


Changyun Xiong

Latest:

An Integrated Prefilled Syringe Platform Approach for Vaccine Development

An integrated focus on product design, development, operation, and control.


Lisa Newey-Keane

Latest:

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.


Kate Smith

Latest:

Clearing Viral Concerns in Animal-Derived Biomaterials

Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.


James Bailargeon

Latest:

Misconceptions of Maintenance and Reliability: A Biopharmaceutical Industry Survival Guide

The authors provide common misconceptions and key concepts behind reliability engineering.



Donghui Jing, PhD

Latest:

Growth Kinetics of Human Mesenchymal Stem Cells in a 3-L Single-Use, Stirred-Tank Bioreactor

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.


David Horn

Latest:

Identification and Quantification of Trace-Level Protein Impurities

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.


Gerry McAuley

Latest:

Optimizing Human Performance: A Road Worth Traveling, Part 3

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.


Andrew Nason

Latest:

Patents and Postapproval Batch Testing

Can postapproval FDA filings immunize pharma companies from patent lawsuits?



Chris Masterson

Latest:

Managing Contract Manufacturing Organization Relationships

Successful management of the CMO/client relationship should include open communication and trust.


Gillian R. Woollett

Latest:

Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?

In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.


Parrish Galliher

Latest:

When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm

The move to single-use manufacturing has prompted a paradigm shift in facility design.



Patrick Bennett

Latest:

Identification and Quantification of Trace-Level Protein Impurities

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.


Clinton Weber

Latest:

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

Traditional project decision-making vs. a QbD approach.


Jens H. Vogel, PhD

Latest:

Polishing Complex Therapeutic Proteins

A new downstream purification platform using a salt-tolerant membrane adsorber.


Tom Fletcher

Latest:

Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology

Advances in cell culture media technology have helped achieve safer biologics.


Ronald A. Rader

Latest:

Cellular and Gene Therapies Face a Manufacturing Capacity Crunch

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.


George Oulundsen

Latest:

Single-Use Redundant Filtration

The authors describe a new assembly for bulk and final drug product filling operations.



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