Listen in to real-time questions and answers from the audience. During “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned.”

Take a look into how automated instruments promote process and product standardization, assist in eliminating the variable human factor of manual processes, and address the complexity of manufacturing life-saving therapeutics.

Does or should speed to clinic impact a company’s decision to build versus buy? Explore this question and others along with lessons regarding capacity and meeting anticipated demand.

When building a production line from lab-based processes, sometimes staff primarily familiar with research might not know the specifics of regulations relating to late-stage drug production.

Learn about some of the major milestones and timelines that must be met throughout the building process with a pharmaceutical manufacturing expert.

Manufacturers know that an empty GMP facility costs a great deal of money, so how can companies balance the cost and labor model.

Are you and your manufacturing team ready to take on the demands of Good Manufacturing Practices, compliance, and regulatory approval?

CMC experts offer some forward-looking thoughts on how AI and Machine Learning will impact CMC, and CMC-related regulatory interactions, in the not-too-distant future.

CMC experts discuss what forces and organizations are defining CMC requirements for biologic therapies moving forward.

How important is early CMC work in the grand scheme of what will ultimately become a submitted CMC package?

CMC experts discuss the advantages of data-driven CMC packages in regulatory preparation and during regulatory interactions.

CMC experts answer audience questions about the cost of advanced PD/CMC applications in biopharma manufacturing, and share perspectives on how to test and validate the new technologies in today’s regulatory environment.

Experts address freeze/thaw considerations and discuss who’s driving the adoption of data-driven PD and CMC applications.

In this segment CMC experts address the tools they, and their peers, are leveraging to achieve CMC data efficiency.

An effective CMC-process development infrastructure is critical to biopharma success, because what good is a great PD model if it won’t scale?

Experts kick off the Bioprocess Online Live event Data-Driven CMC For PD Speed, Regulatory Efficiency in this segment covering when and where new biopharmas should start building out a CMC strategy in earnest.

Watch how our single-use mixing system creates a completely sterile mixing and recirculation process, ensuring your buffer and media are mixed correctly and efficiently.

Ross Acucena, applications director, and Donnie Beers, product manager, introduce our single-use mixing system made to be deployed rapidly to help manufacturers meet development, supply, and cost objectives.

Ross Acucena, applications director, and Donnie Beers, product manager, introduce our highly functional and adaptable microcarrier cell separation bags designed for single-use processes. 

This video demonstrates the Aramus™ 2D single-use bag assemblies reliability in a frozen drop test comparing the fluoropolymer bag to a polyethylene bag.

This video shows examples of the performance of Aramus™ film, polyethylene, and polyolefin film when subjected to cold temperatures.

Janelle Rupkalvis from Entegris Life Sciences describes the options, technologies and suppliers for single use assemblies in low temp bioprocessing.

Janelle Rupkalvis describes the process and options for ordering single use assemblies from Entegris Life Science.

This solution reduces the risk of contamination by aseptically handling samples or aliquots of liquid that would normally have to be collected via open sampling methods such as conical tubes or vials.

Improve your handling, efficiency, throughput, and total cost of ownership in bulk-drug substance and cold-chain applications through a reusable, plastic shell solution.

This cell banking manifold kit can shorten your seed train process from weeks to days with manifolds that enable biomanufacturers to save time, money, and space while reducing contamination risks during upstream processing.

Receive the fluid handling benefits of customization, fast design, and delivery with quality assembly solutions.

Choose the correct bioprocess powder bag to serve as your operations containment and transfer solution, by reviewing the features, benefits, and specifications of this single-use option.

Learn how this buffer capsule filter provides end users with the flexibility to scale their templates up and out, improve process economics, enable multiuse facilities, and reduce contamination risks.

Aramus™ 2D single-use bags that provide high purity, exceptional compatibility, and increased safety for critical process fluids and final products are now available in custom shapes, sizes, and assembly configurations.

Our technology center has everything needed to make educated decisions about what freezing process and products best fit your needs.

PSTP series cartridge filters ensure reliable product processing featuring polypropylene components and a hydrophilic polyethersulphone (PES) membrane enabling economical and efficient use in various pharmaceutical applications.

PSTP series cartridge filters ensure reliable product processing enabling economical and efficient removal of particulate and colloidal contaminants in various pharmaceutical applications.

Made from high-quality stainless steel and heavy-duty plastic material, the freezing shells provide greater bulk drug substance (BDS) protection during handling, more consistent freezing/thawing, and reduced storage density.

Entegris solutions allow you to protect and store your high-value process solutions with reduced risk of product loss, contamination, and compromised quality. Expanding our portfolio further, we offer LN2 (liquid nitrogen) cassettes for use with Aramus™ single-use bag assemblies.

The utilization of single-use (SU) systems continues to grow, and so do the purity concerns of the SU components and their potential impact on high-value final products. From the high cost of product loss due to assembly failures at fill/finish, to the ever-increasing scrutiny from regulatory bodies, every angle requires protective measures. Now, Entegris brings a new level of assurance to your process. The Aramus™ single-use 2D bags are made of a high-grade, gamma-stable fluoropolymer, providing higher purity, greater compatibility, and increased safety for critical process fluids and final products.

Two of the most significant benefits to single-use bioprocessing over reusable manufacturing equipment are lower cost and simpler operation. And yet some processing steps, such as mixing, have not been able to realize these benefits. The Entegris mixing system is designed to maximize simplicity, ease-of-use, and affordability.

Learn about a microcarrier separation system designed to ease the complexity and financial burdens of single-use systems while facilitating a separation process using a streamlined, single-use filter/mesh bag system and peristaltic pump.

These motion bioreactor bags bring the benefits of ultimate customization, fast design, and delivery to cell culture applications to your lab.

What does “custom” mean for bioprocessing companies? Many system suppliers advertise their capability in customization but in reality, limit it to the interchange of components or lengths of tubing. This is helpful, but falls short of what many end users are looking for. With single-use systems, Entegris offers true customization to meet your exact process needs, fast.