Authors


Nina Zolotarjova

Latest:

Enhanced Affinity Columns Simplify Protein Fractionation

The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.


Matthew M. Gardner

Latest:

Final Word: BIO: The Olympics of Biotech

Plan ahead to make the most of every opportunity at this year?s BIO convention in San Francisco.


Perry J. Viscounty, J.D.

Latest:

Copyrights and Trademarks

Trademark protection in the US is based on a dual system of federal and state laws.


Amal Ahmed

Latest:

Cleaning Polyethersulfone Membranes After Ultrafiltration-Diafiltration in Monoclonal Antibody Production

In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.


Heather L. Mayer, J.D.

Latest:

Copyrights and Trademarks

Trademark protection in the US is based on a dual system of federal and state laws.



Sigifredo A Padilla

Latest:

Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1

The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.


Larraine Segil

Latest:

The Human Side of Partnerships

He potential for frustration, time-wasting, and bad feelings between pharma and biotech partners is enormous. That some successful decisions are made under these circumstances is something of a miracle.


Cristina García

Latest:

GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent

Development guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.


Lorna B. Jack

Latest:

Strong government support, a talented workforce, and a thriving research environment drive life sciences excellence in Scotland

International partnerships, an attractive regulatory environment, and robust funding make Scotland a world leader in biotechnology.


Edwin Lightfoot

Latest:

Efficiency Measurements for Chromatography Columns

Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.


Muriel Comrie, Ph.D.

Latest:

Violet Diode-Assisted Photoporation and Transfection of Cells

Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.


Daniel Rudolph, Ph.D.

Latest:

Expression of Recombinant Proteins in Yeast

Yeast systems have been a staple for producing large amounts of proteins for industrial and biopharmaceutical use for many years. Yeast can be grown to very high cell mass densities in well-defined medium. Recombinant proteins in yeast can be over-expressed so the product is secreted from the cell and available for recovery in the fermentation solution. Proteins secreted by yeasts are heavily glycosylated at consensus glycosylation sites. Thus, expression of recombinant proteins in yeast systems historically has been confined to proteins where post-translations glycosylation patterns do not affect the function of proteins. Several yeast expression systems are used for recombinant protein expression, including Sacharomyces, Scizosacchromyces pombe, Pichia pastoris and Hansanuela polymorpha.


James Kacmar

Latest:

Development of a Novel Platform TFF System for Insect Cell Culture Harvest

The overall average flux rate for the concentration and diafiltration step was 41 L m–2 h–1.


Gordon Nicol

Latest:

Enhanced Affinity Columns Simplify Protein Fractionation

The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.


Sergio Garcia

Latest:

How Small Biotechs Should Protect Their Interests During Mergers and Acquisitions

Strategic alliances and partnering deals were a big biotech news story during 2006-with deal values setting an all time record of over $23 billion for the year. The strategic partnering trend continues during 2007 and in this column we present some frequently asked questions and answers about the merger and acquisition (M&A) activity in the life sciences sector.


Peter E. Bryant, Ph.D.

Latest:

Violet Diode-Assisted Photoporation and Transfection of Cells

Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.


Gerd Kern

Latest:

Virus Removal by Filtration: Points to Consider

It is important to ensure that flow decay during processing is comparable to that observed during retention studies.


Bikash Chatterjee

Latest:

QRM Tools for Contract Biomanufacturing

Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.


Don R. Durham, Ph.D.

Latest:

Expression of Recombinant Proteins in Yeast

Yeast systems have been a staple for producing large amounts of proteins for industrial and biopharmaceutical use for many years. Yeast can be grown to very high cell mass densities in well-defined medium. Recombinant proteins in yeast can be over-expressed so the product is secreted from the cell and available for recovery in the fermentation solution. Proteins secreted by yeasts are heavily glycosylated at consensus glycosylation sites. Thus, expression of recombinant proteins in yeast systems historically has been confined to proteins where post-translations glycosylation patterns do not affect the function of proteins. Several yeast expression systems are used for recombinant protein expression, including Sacharomyces, Scizosacchromyces pombe, Pichia pastoris and Hansanuela polymorpha.


Robert Ferguson

Latest:

Violet Diode-Assisted Photoporation and Transfection of Cells

Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.


Andrés Tamayo

Latest:

Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1

The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.


Karin Östergren, M.Sc.

Latest:

Upgrading a Pharmaceutical Laboratory to Part 11 Compliance

FDA's regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1


Jane E. Clark, BSU

Latest:

Final Word: Canada's Landmark Decision: Planting the Seed

Commercial embodiments of genetically modified inventions are protected in Canada.


Katie Henchir

Latest:

Validation Outsourcing: Getting the Most Out of Your Client?Contractor Relationship

Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.



Jeffrey L. Schrimsher

Latest:

PEGylation of Proteins: A Structural Approach

The type of reactive moiety controls the site and stability of the covalent link and also the total number of PEGylation sites on a given protein.


Laura Judy Visioni

Latest:

The Human Side of Partnerships

He potential for frustration, time-wasting, and bad feelings between pharma and biotech partners is enormous. That some successful decisions are made under these circumstances is something of a miracle.



Andrew C. Riches, PhD

Latest:

Violet Diode-Assisted Photoporation and Transfection of Cells

Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.

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