06.14.24 -- Bioprocessing Technology: You Are The Standard

Manufacturing operations are getting a boost thanks to single-use technologies, but how do biopharmaceutical manufacturers choose the right materials for constructing their single-use solutions?

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Learn about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.

Hear from a Senior GMP Scientist about environmental monitoring and contamination control for aseptic pharmaceutical manufacturers, along with the impact of effective cleanroom monitoring.

Compare manually washed labware and labware cleaned in automatic washing systems, to see how the challenges of manual washing can impact your labs efficacy and repeatability.

Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

Cell and gene therapies require adaptive, advanced assays for characterization and safety assessments; in many instances, the assays historically used for biologics must diversify to accommodate them.

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.

Learn about Organ-on-a-Chip technology and how it can be employed to assess the efficacy of CAR T-cell therapies against solid tumors.

Review the results of a study comparing mass photometry and CDMS techniques for their ability to distinguish AAV loading distributions and evaluate adeno-associated virus (AAV) capsid content.

Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using Design of Experiment, thereby reducing variability and risk.

Discover the statistical analysis results based on several DoE studies for the reduction of hcDNA and pDNA levels in a lentiviral vector (LVV) platform process.

This eBook dissects the potency assay development process into its key steps, offering a clearer understanding of the journey.

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment approach.

Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Explore a platform approach to Process Characterization that's been proven effective.

Biotech leaders highlight how to perform critical activities leveraging process and analytical development resources from early-stage clinical to commercialization.

New technologies for the encapsulation of nucleic acids, such as FDmiX, can potentially overcome limitations of currently available standard mixing technologies.

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Here, we review the beginnings of calorimetry and microcalorimetry along with their modern history, applications, and use in biologics drug development.