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BIOMANUFACTURING FEATURED ARTICLES

Six Myths About Serialization
Six Myths About Serialization

Expect that serialization mandates will govern most of world’s drug supply. 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

  • Can We Win The War Against Mycoplasma Contamination?
    Can We Win The War Against Mycoplasma Contamination?

    Biopharmaceutical manufacturers can suffer significant financial losses as a result of a Mycoplasma contamination in a cell culture. Preventing this, though, is easier said than done. Andy Kelly reveals more about the structure of these troublesome microorganisms and detail a study to determine the link between filtration pressure and Mycoplasma retention rates.

  • Automated Dual Feeding Into Recently Converted Bioreactors
    Automated Dual Feeding Into Recently Converted Bioreactors

    This case study explains how Parker Domnick Hunter (a division of Parker Hannifin) helped a pharmaceutical company optimize cell density in cell culture tanks that needed to be converted into fermenters to grow E. coli bacteria.

  • Private Branding: How On-Demand Color Labeling Can Add Value To The Growing Generics Market
    Private Branding: How On-Demand Color Labeling Can Add Value To The Growing Generics Market

    The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.

  • Adaption Of The BioLector Technology To Anaerobic Requirements
    Adaption Of The BioLector Technology To Anaerobic Requirements

    Biorefineries have reignited interest in anaerobic fermentations with biobutanol production being the principle driver. Already during the First World War Biobutanol and acetone were produced in Clostridium acetobutylicum.

  • Despite An Airport Strike, Marken Preserves The Data Chain
    Despite An Airport Strike, Marken Preserves The Data Chain

    Marken collected a shipment from southern Sweden that was bound for next-day delivery in northern Belgium. However, all airline flights into Belgium were cancelled as a result of a strike action by airport workers.

  • Batch Culture Of CHO Cells In The Multifors Cell
    Batch Culture Of CHO Cells In The Multifors Cell

    The Multifors Cell can be used to easily optimise development processes by parallel cultivation of animal cell cultures. Cultivation of the CHO (Chinese hamster ovary) cell line in the Multifors Cell bioreactor (INFORS HT, CH-Bottmingen) is described in the following as an example of batch cultivation of parallel samples.

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BIOMANUFACTURING PRODUCTS

Single-Use Cell Culture Bioreactor Systems: Xcellerex XDR Single-Use Cell Culture Bioreactor Systems: Xcellerex XDR

Xcellerex XDR Single-Use Bioreactor Systems provide scalable and robust stirred-tank performance for up to 2000 L in both GMP and non-GMP environments. Functional in batch, fed-batch and perfusion bioreactor modes, they offer smooth transfer from process development to manufacturing scale, with the convenience and cost-effectiveness of single-use technology.

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.

Single-Use Bioreactor Turnkey With G3Lite Controller Single-Use Bioreactor Turnkey With G3Lite Controller

The all-new redesigned Thermo Scientific™ Single-Use Bioreactor (S.U.B.) tank provides enhanced functionality, ease of use, and efficiency while maintaining interoperability with Finesse G3Lite™ controllers in both the TruBio™ DV and TruBio™ μC platforms. Either of these proprietary platforms is available with this complete turnkey system.

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.

HyPerforma Single-Use Bioreactor (S.U.B.) Condenser System HyPerforma Single-Use Bioreactor (S.U.B.) Condenser System

The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.) Condenser System specifically supports the effective use of the HyPerforma 2000 L S.U.B. and is also available as an auxiliary product for all other S.U.B. systems. It efficiently condenses exhaust gases and transfers condensate back into the bioreactor, preventing potential vent filter blockage and reducing fluid loss due to evaporation. It is offered in both single and double chill-plate formats.

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.

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BIOMANUFACTURING MEDIA

Explore The Impact Of GxP Compliance To The Supply Chain Explore The Impact Of GxP Compliance To The Supply Chain

The main benefit for our customers at the moment is that they should aim for GxP compliance vendors from my point of view because GxP qualified our compliant vendors. They can provide true process control during the whole supply chain. They can insure integrity and stability of the pharmaceutical products being shipped around the globe.

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.

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BIOMANUFACTURING INDUSTRY NEWS

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