Ready-to-use materials and in-line dilution can streamline overall bioprocessing operations.

Improving mAb Manufacturing Productivity

Bioreactor technology advances can offer seamless manufacturing scale-up.

Cell Culture Scale-up Challenges

Articles

An innovation such as synthetic biology can develop a consistently stable starting cell line for cell therapy source material.

Synthetic Biology Offers a Solution to Cell Therapy Source Material Constraints

Melisa Carpio is a global technology consultant for Cell Culture Technologies at Sartorius North America.

Bioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.

Current Challenges with Cell Culture Scale-up for Biologics Production 

This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.

Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines 

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

Using Process Modeling to Troubleshoot a Bioprocess

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

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

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Plasma-Based Antibody Therapies Battle Against COVID-19

Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.

Biopharmaceutical Manufacturing and the Power of Synthetic Biology

New bioreactor designs, coupled with better media, process intensification and analytics, continue to improve upstream bioprocessing.

Bioreactors Redefine Upstream Productivity

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

Sartorius Launches New Automated Single-Use Bioproduction Platform

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 future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.


The Future of Raw Material Sources for mAbs

By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioprocessing.

Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation

The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.

Cell Culture Variables for Gene Therapy Vectors

Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.

Horizon Discovery, Mammoth Biosciences Sign Collaboration and License Agreement

Industry experts debate the pros and cons of “going bigger” than the 2000-L industry norm in a single vessel.

Single-Use Bioreactors: To Scale Up or Scale Out?

The latest advances in upstream technologies include single-use equipment and a protein analyzer for titer monitoring, as well as new plasmid DNA manufacturing capability. 

What’s New in Manufacturing: Upstream Technologies

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.

The Evolving Role of Starting Materials in Cell and Gene Therapy

Agnes Shanley is senior editor of BioPharm International.

Modeling is being used for everything from yield improvement to facility design, but new initiatives plan to broaden its reach, both upstream and downstream.


Modeling Comes of Age in Biopharma

Used with perfusion, alternating tangential flow and tangential flow filtration are redefining upstream efficiency.


Upstream Processing

Improving mAb Manufacturing Productivity

Cell Culture Scale-up Challenges