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Reducing Upstream Processing Scale-Up Risks Using QbD
Reducing Upstream Processing Scale-Up Risks Using QbD

Scientists and engineers seeking to develop manufacturing processes for new biopharmaceutical drugs face a number of challenges. Upstream process development must deliver a high-yielding cell culture to meet Cost of Goods (CoGs) objectives. The process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance. The biological product must maintain the required product quality attributes, during scale-up from laboratory to commercial scale. Biopharmaceutical companies must address these complex challenges in the shortest possible timeframe and at reasonable effort and cost during development. Doing so allows the early evaluation of products in the clinic and, therefore, effective resource allocation behind projects from the pipeline that are most likely to be successful all the way to the market.

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  • 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.

  • 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.

  • 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.

  • Skip Steps In Cell Culturing

    With Cell Culture Flask Adapters, the culture can be centrifuged directly in the flask. Data illustrates that cell yield, cell viability, and endpoint analysis results are comparable when cell cultures are processed traditionally or centrifuged directly in the flask using Cell Culture Flask Adapters.

  • Capture And Purification Of Recombinant Albumin Fusion Proteins Using AlbuPure®
    Capture And Purification Of Recombinant Albumin Fusion Proteins Using AlbuPure®

    Human serum albumin (HSA) has a vast array of applications within the BioPharmaceutical industry including; plasma expansion, formulation excipient, drug delivery, wound healing as well as extending the half-life of a protein drug as a fusion partner.

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Mix-Mode Chromatography Resin Mix-Mode Chromatography Resin

Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.

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.

BalanCD® MDCK: Chemically-Defined Medium for Vaccine Manufacturing BalanCD® MDCK: Chemically-Defined Medium for Vaccine Manufacturing

BalanCD® MDCK has been designed for producing viruses in Madin-Darby Canine Kidney cells (MDCK) cultures. This medium is chemically-defined and animal-component-free.

Flexsafe Single-Use Bags Flexsafe Single-Use Bags

Standard Flexsafe 2D validation bags made of the new polyethylene S80 film are designed for small scale investigations and for the validation of the Flexsafe bag family. They are available in 150 mL and 500 mL volumes to support end users’ process development and validation testing. Flexsafe bags have been designed by combining material science and a Quality by Design approach to provide outstanding cell growth, robustness and assurance of supply for all process steps of biomanufacture.

BioLector® Pro BioLector® Pro

The Biolector® Pro is the first microbioreactor system combining the proven, scalable BioLector® technology with an innovative microfluidic chip.

Minitron Incubator Shaker Minitron Incubator Shaker

With the launch of the Minitron incubator shaker, INFORS HT is following up on the worldwide success of the Multitron incubator shaker. The Minitron has the same outstanding characteristics as its big brother, the Multitron, but on a smaller scale.

2D Bar Code Reader For Storage Vials 2D Bar Code Reader For Storage Vials

WHEATON understands that when it comes to BioBanking, sample integrity means everything.

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Easily Switch Between Washing And Filtration With An Interchangeable Microplate Washer

The Hydroflex microplate washer is a modular and upgradeable platform is ideal for a wide range of cell-, enzyme- and DNA-based applications in academia, biotech, pharma and clinical diagnostics, reflecting over 30 years of Tecan expertise in advanced liquid handling.

Hydroflex™ Microplate Washer With Magnetic Bead Separation

The Hydorflex microplate washer has the option to incorporate a magnetic carrier and it can meet the demand of magnetic bead separation and an innovative, cutting edge method.

Using High Throughput (HT) Methods To Accelerate DOE Video

High throughput experimentation (HTE) was used in this case study in concert with DOE methodology to study the mass recovery of a basic therapeutic protein (pI 9.2-9.5) using a hydrophobic cation exchange mixed mode resin.

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Cell Culture
Cell culture is a complex, highly structured process for growing cells, under strictly controlled conditions, outside of their normal environment. Cell cultures stilluse cultures of cells on flat plastic dishes.
This is referred to as two-dimensional (2D) cell culture. Aside from using Petri dishes for growing cells, scientists have for a long time, grown cells within biologically-derived matrices such as collagen or fibrin.
Today, more and more 3d cell cultures are being used because they more closely resemble the in vitro cell growth environment. Most 3d cell cultures in use today are designed for stem cell research, tissue engineering and drug discovery. As the field continues to grow and expand, 3d cell culture availability will likely expand to include other cell culture related fields.
For non-adhesive cells suspension cell cultures are used. In these cultures a cell is placed in the liquid suspension, stirred with a magnetic stirrer to agitate the cell and make it float freely in the suspension. The cell grows, divides and spreads throughout the suspension.
Cell culture refers to the culturing of cells derived from multi-cellular eukaryotes (cells with a nucleus), primarily animal cells. However cell cultures also exist for plants, fungi and microbes that include viruses, bacteria and microorganisms. Cell culture shares closely related methodology with tissue culture and organ culture.
You can separate cells from tissues for use in cultures several ways. Cells can be purified from blood but only white cells will grow in a culture.  Mononuclear cells can be released from soft tissue using enzymes that break the cells away from their substrate or matrix. Pieces of tissue can also be placed in a growth media and the cells that grow from it can be used for cell cultures.