Authors
Latest:
Release and Stability Testing Programs for a Novel Virus-Like Particle VaccineRelease testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.
Latest:
Cost of Goods Modeling and Quality by Design for Developing Cost-Effective ProcessesCombine cost analyses with QbD to improve operations and lower costs.
Latest:
Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
Latest:
Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
Latest:
Using Information Technology to Enhance Upstream ProductivityTwo case studies show how advanced information technologies make process development more efficient.
Latest:
PEG Precipitation: A Powerful Tool for Monoclonal Antibody PurificationThis alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.
Latest:
Mixed-Mode Chromatography in Downstream Process DevelopmentSalt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.
Latest:
Characterizing the Formulation Design SpaceDesign of experiments is a valuable tool for identifying aspects of a formulation that are critical to product quality.
Latest:
Mixed-Mode Chromatography in Downstream Process DevelopmentSalt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.
Latest:
Polishing Complex Therapeutic ProteinsA new downstream purification platform using a salt-tolerant membrane adsorber.
Latest:
Freeze Bulk Bags: A Case Study in Disposables ImplementationGenentech's evaluation of single-use technologies for bulk freeze-thaw, storage, and transportation.
Latest:
Advancing Adjuvants and Vaccine Delivery Systems for Better Vaccination StrategiesThis article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.
Latest:
Ramping Up and Ensuring Supply Capability for BiopharmaceuticalsBy implementing a comprehensive improvement program for its organizational and operational functions, one company increased capacity by more than 100% and 50% for two of its biopharmaceutical products.
Latest:
PEG Precipitation: A Powerful Tool for Monoclonal Antibody PurificationThis alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.
Latest:
Managing Cell Line Instability and Its Impact During Cell Line DevelopmentBy considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.
Latest:
Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
Latest:
The Grant Story: Why Pursue, Where to Find, and How to Win Research FundingA less-than-favorable venture capital market and a sluggish economy have compelled companies to seek grant money to fund their growth and development activities. Follow these winning strategies for obtaining your next grant.
Latest:
Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
Latest:
Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
Latest:
Optimizing Vaccine Adjuvant FiltrationThe viscosity of oily emulsions can reduce filter capacity and bacterial retention.
Latest:
Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
Latest:
After the Consent Decree — An Uphill Battle for Affected CompaniesQuality should be built into manufacturing systems instead of being imposed as a corrective action.
Latest:
Innovations in Intranasal Vaccine Delivery TechnologyNeedle-free vaccine delivery platforms can solve the problems of stockpiling, cold-chain management, and pandemic preparedness.
Latest:
Biopharmaceutical Facility Cleaning Validation Using the Total Organic Carbon TestCase studies show TOC is effective for cleaning validation.
Latest:
Influenza Vaccine Enhancement with Immunomodulating Peptide Thymosin Alpha 1Clinical studies have shown that treatment with thymosin alpha 1 increases response to vaccination.
Latest:
A Rational, Step-Wise Approach to Process CharacterizationProcess characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.
Latest:
Partial Replacement of Chemically Defined Media with Plant-Derived Protein HydrolysatesPlant-derived hydrolysates can be used as valuable and practical tools to improve cell culture performance.
Latest:
Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
Latest:
Canada: On the Biopharmaceutical Fast TrackCanada's biotechnology industry has expanded rapidly in the last decade, as measured by industry-wide revenues, the launch of new companies, and the continuous diversification of its products.
Latest:
Advancing Adjuvants and Vaccine Delivery Systems for Better Vaccination StrategiesThis article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.
