In biopharmaceutical production, each instance where materials or products in development must be stored, handled, or transported presents a risk for breakage, contamination, and expensive product loss. In a modern, decentralized biopharmaceutical production line, materials and products must be kept frozen to ensure product safety, consistency, and shelf life. Because of these new realities, we face more production costs, logistics, speed, and complexity.
Bioproduction today has dramatically increased the value of product in each container. Production processes have been contracted out or may be taking place in different parts of the country or globe. At colder temperatures, containers have considerable limitations; traditional storage bottles are often more brittle at cold temperatures and can break easily, do not pack into containers or store in freezers efficiently and take longer to freeze and thaw due to their shape and volume.
Entegris is in a unique position to help overcome these cold temperature challenges by offering assemblies designed for extreme cold and by partnering with qualified equipment manufacturers specializing in reliable, cold-chain containment. Let us help you gain control over your processes and reduce the potentially enormous financial risk to your valuable products.
Advantages Of Single-Layer Film Vs. Multilayer Film In Bioprocessing
Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.
Employing Single-Use Technology To Control Frozen Bulk Drug Storage: The Cold Hard Facts
The traditional approaches for primary packaging in frozen applications have been bottles and stainless steel cryo vessels. While each has its strengths, both have significant shortcomings. This paper addresses the challenges of bulk drug substance (BDS) storage, shipping, and other critical factors users must consider in deciding whether and how they will adopt the technology. Also highlighted are specific options to consider in moving toward single-use drug substance storage.
Cold-Chain Bioprocessing Readiness: Mitigating Risk And Protecting Pharmaceutical Products
Many pharmaceuticals — monoclonal antibodies, vaccines, and patient-specific therapeutics — must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that continues throughout downstream processing. This white paper addresses the concerns of development laboratories, contract manufacturing organizations (CMOs), and contract research organizations (CROs) and explains several factors they should consider when expanding operations and selecting single-use systems for cold-chain bioprocessing.
Low-Temperature Solutions For Bioprocess Applications
Janelle Rupkalvis, Life Sciences applications explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.
Cold temperature Performance: Aramus™ Film vs. Polyethylene And Polyolefin Film
This video shows examples of the performance of Aramus™ film, polyethylene, and polyolefin film when subjected to cold temperatures.
Cold Resistance: Reduce Your Low-Temp Bioprocessing Risks
Janelle Rupkalvis from Entegris Life Sciences describes the options, technologies and suppliers for single use assemblies in low temp bioprocessing.
Rapid Turnaround For Customer Orders
Janelle Rupkalvis describes the process and options for ordering single use assemblies from Entegris Life Science.
Single Use Technologies For BDS Freeze/Ship/Thaw
Mike Johnson, Johannes Kirchmair (SUS) explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.