Authors
Latest:
Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit OperationA review of some recent contributions in process chromatography.
Latest:
Devising an International Clinical Trial Distribution Strategy: Genentech's ApproachA decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.
Latest:
Leveraging Fermentation Heat Transfer Data to Better Understand Metabolic ActivityA simple method to leverage fermentation heat transfer data.
Latest:
Advances in Monoclonal Antibody PurificationNew technologies and adaptations of existing technologies can improve platform processes.
Latest:
Failure Mode Effects Analysis for Filter Integrity TestingUnderstanding of the risks associated with FMEA is crucial in lot release testing.
Latest:
The Therapeutic Vaccine Potential of MIS416 AdjuvantThis article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines.
Latest:
Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
Latest:
Upcoming Technologies to Facilitate More Efficient Biologics ManufacturingChoosing the right tools to enhance the process.
Latest:
Versatility of a Single-Use Bioreactor Platform for Culture of Diverse Cell TypesAre disposable bioreactors effective for cell culture?
Latest:
Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit OperationA review of some recent contributions in process chromatography.
Latest:
Solutions for Purification of Fc-fusion ProteinsWhen platform processes are applied to fusion molecules, innovation and flexibility are needed.
Latest:
Opalescence of an IgG1 Monoclonal Antibody Formulation is Mediated by Ionic Strength and ExcipientsCan increase in ionic strength result in higher viscosity?
Latest:
The First Optimized Self-Replicating RNA (srRNA) TechnologyThis inaugural edition of the Pivotal Paper series features leading vaccine experts discussing a groundbreaking study on next-generation self-replicating RNA (srRNA) vaccine technology. The panel explores the study’s key findings, highlighting srRNA’s potential for lower-dose, single-dose vaccines with enhanced immune response, expanding the applications beyond infectious diseases.
Latest:
A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
Latest:
Turning obstacles into opportunities: overcoming efficiency and quality challenges in gene therapy developmentAs the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly while maintaining viral vector quality. This article tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at strategies to optimize viral vector production, manage costs, and collaborate on industry standardization and automation.
Latest:
Exploring Analytical Techniques to Characterize Protein Aggregation in BiotherapeuticsAnalytical techniques are crucial to protein biotherapeutics research, development, and manufacturing. It is important to understand diverse particle characterization techniques and how they relate to each other to ensure the safety and efficacy of drug products.
Latest:
Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
Latest:
Extractable and Leachable Challenges in Lyophilized Drug ProductsThe authors examine the risks of extractables and leachables and present solutions that emphasize the importance of a strategic multi-prong approach.
Latest:
Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.
Latest:
The Road to Personalized Medicine: Reimagining Drug ManufacturingFor cell and gene therapies to reach their full potential, changes in manufacturing must be explored.
Latest:
Big Pharma Meets Big DataBig data is a natural for pharmaceutical industry players that have not already embraced it.
Latest:
Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
Latest:
CRISPR Gene-Editing Technology in the Development of BiopharmaceuticalsNovel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.
Latest:
Challenges When Outsourcing Viral Safety ServicesAssessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.
Latest:
Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
Latest:
2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***
Latest:
Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered ConditionsA case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
