Manufacturing Best Practices

Improving Upstream Predictability

March 02, 2020

BioPharm International

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

The Evolving Role of Starting Materials in Cell and Gene Therapy

December 01, 2019

BioPharm International

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.

Connector Integrity in Single-Use Biomanufacturing Systems

November 01, 2017

BioPharm International

Connectors are a critical element in the process optimization of single-use bioprocessing systems.

Connectors and Sealing Mechanisms—and Their Impact on Process Protection

October 25, 2017

BioPharm International

The use of external retainers to enhance the seal between connectors and tubing is an essential component in single-use manufacturing systems.

Lean Changeover in Biopharmaceutical Facilities: Developing A Risk-Based Approach

July 01, 2016

A streamlined approach may enhance process efficiency and product quality.

Continued Process Verification: State of the Industry

June 01, 2016

BioPharm International

An understanding of continuous process validation can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.

Best Practices in Facility Design

May 01, 2015

BioPharm International

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

Continuous Manufacturing: A Changing Processing Paradigm

April 01, 2015

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

Raw Materials and the Development Cycle

January 01, 2015

BioPharm International

Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.

Continuous Improvement in Biopharma Manufacturing

October 01, 2014

BioPharm International

Unexpected problems can become opportunities to share knowledge and improve processes.