Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Industry 4.0 in Biopharmaceutical Manufacturing

Agnes Shanley is senior editor of Pharmaceutical Technology.

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.

Moving Toward Unified Process Control for Biopharma

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Robotics Solve Aseptic Filling Challenges

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems. 

Sartorius Stedim Biotech and Siemens Collaborate on Automation

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.

Simple by Design

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

Denise L. Miller is document control specialist at Lyophilization Technology, Inc.

Carrie A. Shults is associate director at Lyophilization Technology, Inc.

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.

Identifying TPPs and CQAs for a Lyophilized Parenteral Product

Aaron Strand, PE is a senior research engineer with SPX FLOW, aaron.strand@spxflow.com

Nicolle Courtemanche is a senior application engineer with SPX FLOW, nicolle.courtemanche@spxflow.com

Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.

Impact of Agitator Design on Bioreactor Performance

Lennart Eriksson, PhD, is senior lecturer and data scientist at Sartorius Stedim Data Analytics.

Chris McCready is lead data scientist at Sartorius Stedim Data Analytics

Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.

Characterizing a Bioprocess with Advanced Data Analytics

ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.

Process Control, Automation, and PAT