Ensights

As a world-class supplier of advanced materials and process solutions for the semiconductor space, we understand the complexity and challenges of quality by design with respect to bulk drug cold chain manufacturing. Costly failures can be devastating and, in many cases, can be avoided by partnering with the correct single-use solutions provider to help optimize critical processes. When looking for solutions to protect your therapeutics during bulk drug cold chain, keep the following in mind:

Meet Regulatory Requirements to Ensure Patient Safety Developing and validating a robust freeze/thaw process while meeting regulatory guidelines is a multifaceted challenge. The demand for cold chain processes and operations for biopharma products is increasing due to scaling of complex therapeutics, a challenging global supply chain, and growing shipping complexities. Ensuring compliance throughout the product journey is integral to mitigating risk for product loss and contamination.

Why Switch to our Bags? Supply chain issues? Breaking bags? Freezing problems? Our Aramus™ bags can get you back to making lifesaving therapeutics.

Freezing down bulk drug substance (BDS) isn’t something you can play around with. This is a high value product where any failure or contamination due to the bag breaking can lead to delays in medicine getting to the patient. Making sure you pick the right solution to protecting that product makes a big difference. Here are three questions you should be considering:

The impact of the freeze/thaw process on workflows requires it be treated as a unit operation of its own.

As a partner, Entegris is continuously developing solutions for our customers’ biggest challenges. An unprecedented pandemic came with a one-of-a-kind challenge: help a leading COVID-19 vaccine manufacturer scale up their process.

The pharmaceutical and biopharmaceutical industries continue to embrace the utilization of single-use systems (SUS). With the ever-growing adoption of SUS products, increasing scrutiny has been placed on the purity concerns of single-use components and their possible impact on the biomanufacturing, storage and transportation of high value final products.

Entegris Highlights 2019 2019 was a year of exciting change and significant accomplishments for Entegris including strategic acquisitions, supplier awards, footprint expansions and technology center openings, sustained Five+ Sigma quality levels, hundreds of issued technology patents, and so much more!