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An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Using NMR Spectroscopy to Obtain the Higher Order Structure of Biopharmaceutical ProductsSimple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.
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Keeping Biopharmaceutical Cleanrooms CompliantIt is not likely that you will ever personally design and build a cleanroom; however, you may be responsible for the care and upkeep of many.
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Quality by Design and Compliance ReadinessHow will implementing Quality by Design strategies affect your compliance status?
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Disposables Solve Tomorrow's Manufacturing ProblemsDisposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.
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Myriad Decision Places Biotech at a CrossroadsIn light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Challenges and Innovations with Prefilled SyringesMarket considerations and new technologies must be recognized to achieve the full benefits of manufacturing prefilled syringes.
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Process Harmonization Assessments for Technology TransferA process harmonization assessment can aid in smooth technology transfer by comparing data across equipment and sites.
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Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS MethodsIntact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
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Biophysical Characterization for Product ComparabilitySpectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.
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Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
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Mathematical Programming for the Design and Analysis of a Biologics Facility-Part 2An algorithmic approach to fine tune facility design and predict capacity.
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Addressing Unmet Medical Needs Through Tailored Vaccine Design: The Importance of Adjuvant SystemsIt is now possible to combine antigens with specific adjuvant systems to create more effective vaccines.
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Site-Directed Engineering of Defined Chromosomal Sites for Recombinant Protein and Virus ExpressionMethod for integration of transgenes.
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MALDI-DIT Analysis of Modification Site of Chemically Modified AntibodyThis application note showcases the high MSn analysis capability of an ultra-compact MALDI digital ion trap (DIT) mass spectrometer, and its ability to obtain information from modified peptides.
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Characterization of Aluminum Hydroxide Gel and Oil-in-Water Emulsion Formulations Containing CpG ODNsAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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Validation of Commercial-Off-the-Shelf Calibration Management Systems: Managing Instruments Cost-EffectivelyBiotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.
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Recent Patent Rulings Can Impede the Progress of Personalized MedicineThe Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.
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Use of Contract Analytical Laboratories: A Pfizer Global Biologics PerspectiveBy following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
Latest:
An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
