Authors
Latest:
Benefits of a Revised Approach to Anion Exchange Flow-Through Polish ChromatographyA high-performance anion exchange resin performs well compared with membranes. In addition, the resin offers greater flexibility and cost savings.
Latest:
Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
Latest:
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making vs. a QbD approach.
Latest:
Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
Latest:
Addressing the Challenges in Downstream Processing Today and TomorrowNewer classes of biotherapies will require innovations in processing technology.
Latest:
Technologies for Downstream ProcessingThe author describes recent developments to help overcome the downstream-processing bottleneck.
Latest:
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic ProductsEstablishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
Latest:
The Use of the ATF System to Culture Chinese Hamster Ovary Cells in a Concentrated Fed-Batch SystemCell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.
Latest:
Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug SubstancesThe authors re-examine environmental controls in the context of technical advances in manufacturing.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing ContainersThe authors review efforts to limit polymer degradation without significantly impeding cell growth.
Latest:
Adopting the Product Lifecycle ApproachThe author presents opportunities and challenges in implementing the product lifecycle approach.
Latest:
Quality by Design and Extractable and Leachable TestingThe author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Latest:
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
Latest:
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
Latest:
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
Latest:
Rapid Early Process Development Enabled by Commercial Chemically Defined Media and MicrobioreactorsThe use of commercially available media to achieve high titer in early process development is discussed.
Latest:
Disposable Bioreactors for Viral Vaccine Production: Challenges and OpportunitiesSwitching to single-use bioreactors can have financial and performance benefits.
