INSIGHTS ON MANUFACTURING LOGISTICS

• The Cryopreservation Process And Its Impact On The Consistency Of High-Quality Cell Therapy Products

  Explore the underpinning mechanisms driving freeze thaw applications and their implications across varied drug product containment configurations and volumes,

• Impact Of Scalable Freeze/Thaw Cycling On Protein Stability And Structure

  The need for low-temperature storage capable of surmounting the molecular and logistical challenges associated with these treatments has become core to achieving commercial-scale production.

• Product Loss? RoSS Shell Protects Your Single-Use Bag

  Protect any single use bag with RoSS: Robust Storage and Shipping. The right material at the right place – what we can learn from oysters.

• Safely Transport ATMPs In Single-Use Bags

  Cell and gene therapies yield a small volume of individualized product for each single patient. Loss of the shipment or damage to the transported goods have serious consequences for patients.

• Protecting Single-Use Bags To Foster Their Progress

  12/19/2021

  There is still potential product loss with unprotected single-use bags, and there are still human errors dampening the euphoria of single-use systems. Here's how to protect your product investment.

• USP Particulate Testing

  12/3/2021

  Join us as speaker Mark Bumiller, technology manager at Entegris, discusses particle sizing methodology, equipment selection, software validation, and compliance to meet the USP standards for parenteral drug manufacture, proteins, ophthalmic solutions and lipid emulsions.

• Particulate Contamination Levels In Single-Use Systems

  11/29/2021

  More scrutiny has been given to the purity concerns of single-use components and their potential impact on biomanufacturing, storage, and transportation of high-value final products. In this study, we investigate material adsorption of mRNA-encapsulated lipid nanoparticle (LNP) formulation comparing the Aramus fluoropolymer bag to commonly used glass vials and polypropylene (PP) cryotubes.

• Do RoSS Single-Use Bag Shells Affect Cleanroom Sterility?

  11/18/2021

  RoSS shells contain 3D foams to protect and immobilize the filled and frozen bags while transporting. In this study we tested the RoSS shell's influence on the sterility on ISO cleanrooms

• VeriPac 465 Micro Leak Test System For Parenteral Products And Rigid Containers

  11/16/2021

  The VeriPac 465 is a deterministic micro leak test system for container closure integrity testing combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based leak detection technology to date.