INSIGHTS ON CRITICAL ENVIRONMENTS

• Dancing In The Bioprocessing Ballroom: Voices Of Experience

  Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.

• "Validation" Or "Qualification" – What’s The Difference?

  What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

• Full Single-Use Downstream Process? Not Any Time Soon

  Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems in the near future.

• How Can Your Biomanufacturing Facility Benefit From Process Automation?

  With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?

• Modular Bioprocessing Alleviates Drug Manufacturing Woes

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

• Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations

  A GMP manufacturing suite was developed which included a custom-designed and constructed Clinical Manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

• System And Production Hygiene Method Using Sodium Hydroxide

  The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed.

• Start With The End In Mind—GMP Tech Transfer

  How can you be one step ahead in process development and prepare for future GMP work? Learn what tech transfer experts say about this. And discover how to apply their approach to your process.

• Shipping, Assembling, And Installing Bulky Exhaust Equipment In A Lab

  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.