Development

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

Articles

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Proposing a New Method of Detecting Pinholes in Single-Use 

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology 

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Using Process Modeling to Troubleshoot a Bioprocess

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Eliminating Residual Impurities Starts with a Strategic Plan

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

NIIMBL Funds Projects with $10 Million for Advances in Biopharma Manufacturing Innovation

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Ensuring Smooth Tech Transfer of Bioprocess Operations

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

Agnes Shanley is senior editor of Pharmaceutical Technology.

Better understanding and control of cell behavior is yielding benefits, upstream and beyond. 


Improving Upstream Predictability

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

The Need for Advanced Process Modeling for New Therapeutic Biologics

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Mapping a Route for Cell and Gene Therapy Process Development

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.

Antibody Purification Process Development and Manufacturing

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.


Review by Exception: Connecting the Dots for Faster Batch Release

Agnes Shanley is senior editor of BioPharm International.

Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.


Biopharma modeling, now and five years from now

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPs

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

New Therapies Present Scaling Challenges

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

The Principle of Scaling Down

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

GE Healthcare, CPI, and Cobra Biologics Introduce New AAV Purification System

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.