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Merck Uses Automation And Disposables To Drive Upstream Process Development

Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become.  Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen

  • At Ferring Pharmaceuticals, Peptides And Proteins Make Significant Advances
    At Ferring Pharmaceuticals, Peptides And Proteins Make Significant Advances

    Dr. Keith James joined Ferring Pharmaceuticals as VP of Therapeutic Innovation in early 2012. In December 2012 he was promoted to president of the Ferring Research Institute and SVP of R&D for Ferring Pharmaceuticals. Prior to joining Ferring, Dr. James spent 29 years working for Pfizer, with significant time spent in discovery research. At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress he will speak on recent progress and future prospects in the peptide and protein therapeutic space. I recently spoke with Dr. James to get an overview of the potential in this market.

  • Fundamentals Of Viral Clearance Studies Part 4: Considerations For Evaluating Viral Clearance By Chromatography Steps
    Fundamentals Of Viral Clearance Studies Part 4: Considerations For Evaluating Viral Clearance By Chromatography Steps

    Chromatography steps are typically the backbone of the purification process for a biopharmaceutical product, and are usually included in the evaluation of the viral reduction capacity of a manufacturing process.   In viral clearance studies of chromatography steps, the capacity of the chromatography resin to provide physical separation of the spiked virus from the product fraction is determined.  Viral reduction by chromatography steps is considered less robust than by other less complex steps, such as inactivation steps.  By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance

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  • Golden Rules For Working With Cell Cultures
    Golden Rules For Working With Cell Cultures

    Susi and Adi know from their own (sometimes bitter) experience the sort of things that cause problems for them and their colleagues in cell culture bottles in the lab.

  • Scale-Up Of Microbial Fermentation Using Recombinant E. Coli
    Scale-Up Of Microbial Fermentation Using Recombinant E. Coli

    Fermentation production facilities can utilize the Thermo Scientific™ HyPerforma™ Single-Use Fermentor (S.U.F.) instead of traditional stainless steel cleaning-in-place/ sterilization-in-place (CIP/SIP) fermentor vessels without modifying their existing procedures.

  • 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.

Animal Product Free Microcarriers

Animal Product Free Microcarriers

SoloHill Animal Product Free Microcarriers offer high performance options for researchers wishing to limit or remove animal sources from their processes. They address the worldwide concern with the spread of bovine spongiform encephalopathy (BSE) from cattle to humans as vCJD (variant Creutzfeldt-Jakob disease) which has driven the world's regulatory agencies to strongly suggest the eventual removal of all animal proteins from pharmaceutical manufacturing processes.

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.

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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.

EMD Millipore Launches Direct Detect IR-Based Quantitation System At Pittcon 2012

EMD Millipore Launches Direct Detect IR-Based Quantitation System At Pittcon 2012

Nuno Goncalves discusses Direct Detect — the first IR-Based Protein Quantitation system. Accurate protein quantitation in complex mixtures is crucial for obtaining reproducible biological and biochemical data for both upstream and downstream applications.
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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.