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BIOMANUFACTURING FEATURED ARTICLES

Six Myths About Serialization
Six Myths About Serialization

 Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • Considerations To Ensure Successful Scale-up Of Single-use Processes
    Considerations To Ensure Successful Scale-up Of Single-use Processes

    Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.

  • How Can You Mitigate The Risks Of Single-Use Bags?
    How Can You Mitigate The Risks Of Single-Use Bags?

    The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.

  • Making The Switch To Single-Use: Have You Thought Of Everything?
    Making The Switch To Single-Use: Have You Thought Of Everything?

    In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.

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BIOMANUFACTURING WHITE PAPERS AND CASE STUDIES

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BIOMANUFACTURING PRODUCTS

Single-Use Vessels For Cell Culture: BioBLU® c And BioBLU p Single-Use Vessels For Cell Culture: BioBLU® c And BioBLU p

Combine the benefits of single-use bioreactor technology with the reliable performance of conventional glass or stainless steel bioreactors – Discover the Eppendorf BioBLU product line.

One Film For Your Entire Upstream Production: CX5-14 One Film For Your Entire Upstream Production: CX5-14

Thermo Scientific CX5-14 film is engineered to meet the most demanding requirements of your bioproduction processes.

Single-use Clarification Systems: Sartoclear Dynamics® Single-use Clarification Systems: Sartoclear Dynamics®

Sartoclear Dynamics® is a new single-use technology for harvesting animal cell cultures with high cell densities. Consistent results, ease of use, enormous speed and flexible scalability are the key characteristics of this technology.

HyPerforma™ Single-Use Fermentor (S.U.F.) HyPerforma™ Single-Use Fermentor (S.U.F.)

The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency. 
 

HyClone Cell Culture Media, Sera And Process Liquids HyClone Cell Culture Media, Sera And Process Liquids

In March 2014, GE Healthcare Life Sciences announced the completion of the acquisition of the HyClone cell culture media business  from Thermo Fisher Scientific.  The addition of the HyClone portfolio significantly broadens our existing capabilities in life sciences research and bioprocessing. The result is a comprehensive portfolio of products and services across the whole biomanufacturing workflow, from upstream to downstream, from discovery to commercialization.

Emphaze™ AEX Hybrid Purifier Emphaze™ AEX Hybrid Purifier

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

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BIOMANUFACTURING MEDIA

H.R. 3204 Drug Quality And Security Act H.R. 3204 Drug Quality And Security Act

After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.

 

Concentrate 6 Flasks At A Time With The Rocket™ Evaporator Concentrate 6 Flasks At A Time With The Rocket™ Evaporator

The Rocket Evaporator is designed to dry or concentrate as many as six flasks, each containing up to 450mL of solvent.

Interview With Dave Bode: A New Breed Of Healthcare Supply Chain Partner Interview With Dave Bode: A New Breed Of Healthcare Supply Chain Partner

At the most recent eyefortransport Life Sciences conference, SupplyChainBrain asked Dave Bode, DSC's Vice President, Health Care Solutions, to describe the difference between what kind of supply chain partner life science companies need now to accomplish their business goals and what used to be sufficient.

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BIOMANUFACTURING INDUSTRY NEWS

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