Newsletter | March 11, 2024

03.11.24 -- 21 New Downstream Technologies Being Considered To Fix Capacity Problems

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Webinar: The Increasing Demand For Sterile Filtration Of High Concentration Drugs

Industry experts share the current trends and challenges associated with the manufacture of high concentration drug products and provide an overview of their preferred approach to perform extensive filterability trials without the need to generate a high quantity of expensive product. Click here to learn more.

FEATURED EDITORIAL

21 New Downstream Technologies Being Considered To Fix Capacity Problems

Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.

INDUSTRY INSIGHTS

Organ-Chips And Organoids: Better Together

Combining organoids with organ-chips enables the development of more accurate human biological models. Learn how these technologies open the door for new experimental approaches and more.

Navigate The Evolving Antibody Therapeutic Landscape

There are several important factors developers and manufacturers will need to consider to effectively support antibody therapeutics and navigate the trends and challenges on the horizon.

Bioprocess Solutions: Advancements With Single-Use Technology

The integration of single-use technologies in upstream and downstream bioprocessing stages has transformed manufacturing by improving efficiency, reducing costs, and minimizing contamination risks.

How To Measure Particulate Contamination Levels In Single-Use Systems

Compare single-use system bags and learn why both particulate levels and minimizing contamination are important for single-use systems.

SAP S4HANA Implementation: Commissioning, Qualification, And Validation

Explore how CAI helped the company to navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.

Preparing For An Imminent Transformation In How We Treat Diseases

Learn what some practical considerations are for implementing NAT-based methods, where concrete recommendations are necessary, and how guidelines can remain relevant for new medicinal products.

Leveraging Biofunctional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Advantages Of A CDMO With Internal Biosafety Testing Capabilities

Learn about three biosafety testing methods that are commonly applied: in vitro adventitious virus (IVV), species-specific virus testing such as minute virus of mice (MVM), and mycoplasma.

Ready To Amplify Plasmid (pDNA) In Bacteria?

Explore how to use and amplify pDNA from the development of recombinant proteins and viral vectors to advanced biotherapeutics such as mRNA vaccines.

Cryopreservation Best Practices For Cell And Gene Therapy Source Material

Industry experts share their experiences, including why and how cellular source materials are cryopreserved and why experience across cell types and methods matters.

Process Control And Performance Of A Virus Filtration System

Discover a single-use automated filtration system designed to deliver robust process control and integrity assurance during the critical purification step. Explore its design features, processing control, and more.

Development And Regulation Of Veterinary Monoclonals

Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

Robust Off-Gas Analyzers For High-Throughput Bioreactor Facilities

Learn about an off-gas analysis system for bioreactors that can provide slightly faster response times than commercially available analyzers.

Simplifying EV/Exosome Research And Development

Modern solutions are continuing to be developed to help those working in biologics overcome historic exosomes / extracellular vesicles challenges.

Effective Technology Transfers For Mammalian-Derived Biologics

Technical transfers are one of the most critical, yet challenging steps in drug development; therefore, an effective strategy is essential to accelerate the translation of projects from bench to market.

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