BioPharm International, July 2022 Issue

The Difference between Electronic Records Retention and Archiving

July 06, 2022

Ask The Expert

35

7

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

Automating Biopharma Manufacturing

July 02, 2022

Cover Story

35

7

Automation and digitalization work together in the digital plant.

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

July 02, 2022

Peer-Reviewed Research

35

7

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Evolution to a New Clinical Research Environment for Cellular Therapies

July 02, 2022

Development

35

7

Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.

Plant-based Expression Systems are Gaining Mainstream Advantage

July 02, 2022

Upstream Processing

35

7

Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.

Quality by Design for Affinity Chromatography

July 01, 2022

Downstream Processing

35

7

Enriching process understanding enables robust process controls.

Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical Processing

July 01, 2022

Manufacturing

35

7

Specialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.

Material Management and the Impact on Extractables and Leachables

July 01, 2022

Analytics

35

7

By understanding potential material change, the impact on patient safety can be understood and mitigated.

The Road Ahead for the Pharma Cold Chain

July 01, 2022

Supply Chain

35

7

Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.

Improved Formulations to Enable Stable Delivery of Biologics

July 01, 2022

35

7

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

FDA Advances Quality Initiatives to Combat Drug Shortages

July 01, 2022

Regulatory Beat

35

7

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

Process Development Struggles with Molecular Diversity

July 01, 2022

From the Editor

35

7

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

How Can We Come Up Short So Often?

July 01, 2022

From the CEO

35

7

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.