| COVER STORY |

A Plastic Pipeline for Commercial Bioprocessing?

Rita C. Peters

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
read more

| UPSTREAM PROCESSING |

Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs

Christopher H. Taron, Ian Walsh, Xiaofeng Shi, Pauline M. Rudd

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
read more

| DOWNSTREAM PROCESSING |

Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability

Jeff Kenvin

Non-destructive surface area measurement can improve stability testing.
read more

BioPharm International October Issue

| PEER-REVIEWED |

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

Ronan McCarthy, Nick Hutchinson, Isabelle Uettwiller, Amélie Boulais, François Coutard, Eve DePauw, Ludovic Bouchez

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
read more

| VIEWPOINT: RISK AND KNOWLEDGE MANAGEMENT |

Can QRM Transform Biopharmaceutical Operational and Quality Culture Excellence?

José C. Menezes

Applied throughout a product's lifecycle and across a company's portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
read more

| OUTSOURCING DEVELOPMENT |

Outsourcing Development: Small-Scale to Commercial

Susan Haigney

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
read more

| GUEST EDITORIAL |

AAPS Traces the Path to ICH M10

Binodh DeSilva

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
read more

| REGULATORY BEAT |

FDA Clarifies Worldwide Inspection Policies

Jill Wechsler

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
read more

| ASK THE EXPERT |

The Link Between Data Integrity and Quality Culture

Susan J. Schniepp

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
read more