Biomanufacturing Solution Center

BIOMANUFACTURING FEATURED ARTICLES

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.

• Implementing Single-Use At Bioprocessing’s Core
• What’s Next For Single-Use Technology In Bioprocessing

• 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?

  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?

  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.

BIOMANUFACTURING WHITE PAPERS AND CASE STUDIES

• Animal Component-Free, Fast-Attaching Microcarriers For Mammalian Cell Culture

  With the continuing move of the biopharmaceutical and cell therapy industries toward the use of animal component- free materials in biomanufacturing processes, Pall Life Sciences has added a new, animal component-free microcarrier to its already extensive portfolio. Introducing Star-Plus, a rigid, spherical, low density microcarrier, featuring a proprietary chemistry built on the SoloHill® polystyrene core resulting in one of the fastest-attaching microcarriers available for many cell types under a variety of environmental conditions.

• Can We Win The War Against Mycoplasma Contamination?

  Mycoplasma maybe the smallest class of free living microorganism, but the consequences of a contamination in a cell batch during bioprocessing can be huge.

• 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

  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

  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

  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.

BIOMANUFACTURING PRODUCTS

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

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

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.)

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

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

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.