Sponsor
  Bioanalytical Labs Market Dynamics And Service Provider Performance
 

ISR keeps a finger on the pulse of the bioanalytical lab market to help both sponsors and providers stay current with market dynamics and anticipate changes that may be coming down the pike. This data can be used to plan for future resource requirements, develop outsourcing strategies, inform tactical/operational and strategic planning, enhance service offerings, and for organizational benchmarking. Learn more.

Featured Editorial
Help! My Isolator Is Taking Too Long To Degas — What Should I Do?
 
By Herman Bozenhardt and Erich Bozenhardt

Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

Health-Based Exposure Limits: How Do The EMA’s Q&As Compare With New And Forthcoming ASTM Standards?
By Andrew Walsh, et al

The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health-based exposure limits.

Industry Insights
Is Your Sterile Injectable Ready For Changes In Raw Materials?
Article | By Lisa Cherry, Ph.D., Pfizer CentreOne Contract Manufacturing

Over the life of a drug, changes in raw materials are inevitable. But even a small modification can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Maintaining Aseptic Barriers In Biopharmaceutical Manufacturing
Article | By Jürgen Metzger, Bosch Packaging Technology

Determine suitable barrier technologies in biologics manufacturing processes with aseptic filling operations that require protecting operators from highly potent pharmaceuticals, and vice versa.

7 Key Areas Of Risk In Single-Use Bioprocessing: Is Your Process Protected?
Article | By Andrew Kelly and Graeme Proctor, Parker Bioscience

Is your bioprocess adequately protected against the risks associated with single-use technology (SUT)? Discover the seven key areas of risk in SUT and learn the strategies to protect against each risk.

Different Environments Where Bacterial Endotoxins Can Be Found
Article | FUJIFILM Wako Chemicals U.S.A. Corp.

They are many environments that may be contaminated with bacterial endotoxins, since Gram-negative bacteria are characterized by their great level of ubiquity.

Inaccurate Forecasting Is Here To Stay: Focus On Managing Risk Instead
Article | Patheon

It’s no secret that drug forecasts are notoriously incorrect, and often by large margins. With no signs of improvement in forecasting accuracy, how do companies minimize risk?

Are The Components In Your Prefilled Syringes Compatible?
Article | Parenteral Drug Association (PDA)

While a prefilled syringe offers many advantages for biologic products, manufacturers must evaluate the potential impact of a prefilled syringe on product quality prior to selecting the final components.

Evaluation Of Chromassette Packed With Cation Exchange Resin
Application Note | JSR Life Sciences

A modular chromatography technology that readily meets today’s bioseparation scale-up demands for improved ease of use.

Collaborative Project To Accelerate Downstream Biosimilar Processes
Case Study | GE Healthcare Life Sciences

This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein.

Complete Single-Use ADC Technology From Development Through Scale-Up
Case Study | MilliporeSigma

MilliporeSigma was commissioned to perform the technology transfer and optimization of bioprocess chemistry and associated analytical methods for the production of the antibody-drug conjugate ADC-X.

Test Parameters For The Leak Test Of Single-Use Systems With The Palltronic Flowstar LGR Instrument
White Paper | Pall Biotech

Leak testing of single-use systems (SUS) or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer that may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss.

Solutions
Small Molecule API
Patheon
SciLog SciPure FD System
Parker Bioscience
Scientific Search
Dassault Systèmes BIOVIA
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