Ensights

Entegris is proud to collaborate with Kuhner Shaker in the development of a 2500L single-use bag that could exceed their complex requirements while meeting their production needs at scale. Delivering a reproducible product every time, with the ability for specialized applications across scales is what Entegris does best, and this joint effort is no exception. Kuhner evaluated several bag designs for robustness in their 30-day shaking process that were not able to meet the requirements. The Entegris design not only met the need for 30 days of use but was still going strong over 100 days of continuous use.

Entegris is proud to announce a new relationship with Farrar Scientific, by Trane Technologies – a global climate innovator. Farrar offers best-in-class operating systems for ultra-cold temperature storage and controlled rate freeze/thaw chambers for pharmaceutical, biotech, and biorepository applications. Entegris offers the best-in-class Aramus™ bag for robust cold storage and transport. Collaborating with Farrar enables Entegris to offer a combined solution that accelerates the freeze/thaw process.

Entegris is proud to announce a new relationship with HOF Sonderanlagenbau GmbH, an international provider of freeze/thaw equipment and special solutions for the pharmaceutical and biotechnology sectors. Entegris offers the best-in-class Aramus™ bag for robust cold storage and transport.

Whether it is a deliberate strategy or serendipity, the innovations that shape our lives are the result of skilled people put into the right environment to create something new. Innovation is not an exact science, but persistence and some good luck have yielded all the amazing tools and technology we rely upon.

Entegris recently participated at SEMICON West in San Francisco, CA, July 12 – 14. After three years without a major onsite presence, the team was eager to be back in person and engage face-to-face with key customers and suppliers.

Like Benjamin Franklin once stated, “An ounce of prevention is worth a pound of cure.” This could be said for mitigating risk to storage of your biologics too. Even the slightest temperature change from a freezer door being opened and closed numerous times to setting alarms off while searching for product hidden inside can compromise drug product. Losing time and money over product can be prevented. Here are some tips to keep your biologics viable in both long- and short-term freezer storage.

Protecting your product throughout the freeze/thaw process can be a delicate task. Freeze too slowly, your proteins may aggregate and degrade. Thaw in a water bath, you might encounter contamination. Most commonly, cryo-concentration, where your protein is not evenly distributed throughout your frozen container, poses a risk to critical product quality attributes. There are countless ways improper freeze/thaw processes can ruin sensitive therapeutics and cell and gene therapies, but the proper tools can help you reduce cryo-concentration and bioburden while achieving the best return on investment and optimization of your process.

The great resignation, retirement, and an increase in remote work have caused instability across every industry, this is especially true in cell and gene therapy. Getting critical therapies to market has been increasingly difficult due to the high demand for team members with experience in this area, so what can companies do to help combat this?

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.

A major difference exists as more features from our smartphones are integrated, replicated, and expanded in our cars - reliability expectations. A smartphone is designed to work effectively for 3-5 years while cars expect 10-15 years with standard maintenance. Failure in our cars can create dangerous situations for drivers, passengers, and others on the roadway. Designing and manufacturing our cars to ensure the functional safety along with the performance expectations of our new digital transportation systems is challenging manufacturing models for carmakers.

The expanding need for massive data storage and processing has driven the migration from 2D to 3D architectures for logic and memory chips. These complex architectures, with their high aspect ratio (HAR) designs and ultra-thin layers, are forcing advances in metal and oxide deposition processes. Atomic layer deposition (ALD) is usually the method of choice for producing uniform layers with precisely controlled composition.