Newsletter | June 6, 2019

06.06.19 -- Is Continuous Manufacturing Right For Your Drug Product?

  Small Molecule Drug Product Contract Manufacturer Quality Benchmarking (2nd Edition)

This market research report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 23 performance attributes specific to drug product manufacturing projects. You can purchase the full report or download a free preview by clicking here.

Featured Editorial
Is Continuous Manufacturing Right For Your Drug Product?
By Jerry Martin

Developing a continuous manufacturing (CM) process for a new drug, or implementing CM for an existing batch process, demands significant time, effort, and money. Adapting any manufacturing process to CM requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

Techniques For Risk-Based Validation Using ASTM E2500
By Michele Levenson, Pharmatech Associates

This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective.

Industry Insights
How Pharmaceutical Shipping Influences Logistics Trends
Article | By Kevin Lawler, Pelican BioThermal

Considering the changes over the last few years, and looking ahead to 2018, there are four predictions for pharmaceutical shipping trends that will also likely influence logistics overall.

Is Your Biologic At Risk For Protein Aggregation? Part 3
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

The main culprit of a failing biologic drug is usually a flawed formulation. In this article, we cover formulation components and how they may affect protein aggregation. This is Part three of a three-part series.

Shipping, Assembling, And Installing Bulky Exhaust Equipment In A Lab
Article | By Robert K. Haugen, Flow Sciences Inc.

Though delivering, unloading, staging, and assembling are required steps in all lab construction, there are design aspects of lab equipment that can contribute to its successful field installation.

Improving Sterility Assurance Within Lower-Grade Cleanrooms
White Paper | By Christian Dunne, ChargePoint Technology

Better aseptic powder handling through the use of high-tech split butterfly valves can improve patient protection, improve working conditions for staff, and cut costs through the use of lower-grade cleanrooms.

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry
Webinar | By Aryo A. Nikopour, Nitto Avecia Pharma Services

This presentation discusses the basic definitions of extractables and leachables, including details from a case study done using prefilled syringes and a second done using a single-use bag.

Optical Rotation And Quality Control
Article | Anton Paar USA

The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

Ensuring Strength And Flexibility Of Single-Use Bags In All Applications
White Paper | Sartorius Stedim Biotech

The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.

Modular Bioprocessing Alleviates Drug Manufacturing Woes
Case Study | GE Healthcare Life Sciences

Building a bioprocessing facility is usually a complicated process; it requires partnering with not only drug developers, but also many different experts in various industries.

Innovative Packaging For A Two-Component Device Inhaler
Case Study | PTI Packaging and Inspection Systems

WALDNER solves a packaging challenge for a global pharmaceutical company with an ingenious filling and sealing machine.


BioProcess International is the largest bioprocessing event bringing you the science, technologies, and partners needed to accelerate promising biologics toward commercial success. Register today to join 2,000+ bioprocessing scientists and engineers at this year’s meeting, held September 9 to 12, 2019, in Boston.

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