INSIGHTS ON CRITICAL ENVIRONMENTS

• How To Implement Cleanroom Upgrades While Operating Your Facility

  It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are a steps to help maintain control of production and changes—and demonstrate proof of control—while keeping the involved workers and the products safe.

• 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.

• 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.

• A Guide To Cleanroom Construction Methodologies

  Your future cleanroom is a critical asset, it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

• 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.

• Accelerated Commercial Supply With Modular Cleanrooms

  Modular cleanroom systems are increasingly chosen over a conventional construction approach due to their accelerated design and installation schedule advantages, as well as their reduced job-site safety risk during installation.

• Three Options To Viral Vector Manufacturing Capacity

  Industry thought leaders working in the viral vector manufacturing space recently participated in a Virtual Think Tank (VTT), a unique thought leadership platform that brings together leading minds, to discuss viral vector manufacturing facility design. The focus of the most recent VTT was on the current challenges and trends influencing design considerations for viral vector manufacturing facilities and how they can impact companies developing cell and gene therapies.

• "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. 

• Never To Early To Plan For Automation

  Your automation strategy can be designed to expand with your business if you consider your choices in the initial stages. Early platform design selections can greatly affect your future flexibility and ability to show compliance throughout regulatory reviews.