Newsletter | February 12, 2025

02.12.25 -- ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction

SPONSOR

Finally, a Scalable Weak AEX-HIC Mixed-Mode Resin!

Bio-Rad's new Nuvia wPrime 2A Media is a weak anion exchange-hydrophobic multimodal chromatography resin that offers superior selectivity. The strength of the resin's AEX mode can be modulated to meet your specific needs. With robust chemical and mechanical stability, and reliable and resilient performance, this resin can help improve process economics and productivity while delivering high biomolecule purity and yield at lab-to-process scales. Learn more and request samples.

FOCUS ON DOWNSTREAM MANUFACTURING

ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction

This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

Eliminate Downstream Bottlenecks In Antibody-Based Therapies

Organizations seeking greater efficiency within their downstream purification processes are well-served in considering a single-use, membrane-based solution in lieu of resin-based purification columns.

Optimizing Time And Cost Efficiency In Cell Line Development

Discover a system that automates mAb purification, reducing time and costs in cell line development while improving reproducibility, with faster processing than traditional methods.

Unlocking The Potential Of Your Sterile Injectables With Exact SI-ence

Sterile injectables present multiple hurdles on the path from early clinical phases to commercial. Learn how a partner with extensive capabilities and expertise can help streamline the path to market.

A Guide To Scaling Protein Purification

Discover the essentials of scaling protein purification and tackling challenges like purity, cost-efficiency, and scalability. Gain practical strategies and solutions to achieve reproducible, scalable results.

Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process

Two post–Protein A capture two-step mAb processes were developed and compared to an archetypical three-step mAb purification process using two IEX steps after Protein A capture.

Risk Control | Bulk Filling Application

Learn about a bulk filling system that enables you to achieve risk control, accuracy, and superior product recovery in your fill and finish operations.

Predicting Viral Clearance In Downstream Process Development

Optimize purification steps and determine with confidence whether process steps and parameters are effective before investing resources in regulatory supporting validation studies using live virus.

Designing Successful Viral Clearance Studies

Review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

DOWNSTREAM MANUFACTURING SOLUTIONS

Yield-Maximizing Drug Manufacturing Technology - Argonaut Manufacturing Services

Be A Gain Changer, 2x Throughput, Only With Supor Prime - Cytiva

Resolute BioSMB Multi-Column Chromatography - Sartorius

Instruments For Automated Sample Preparation - Thermo Fisher Scientific

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Webinar: Efficient Downstream Processing of Antibody-Based Therapeutics – A CDMO Perspective

The purification of therapeutic monoclonal antibodies has become increasingly standardized, yet not all platform processes achieve the same level of efficiency. Join us as industry experts discuss downstream process development, trade-offs between speed, cost, purity, and yield, and strategies for handling complex molecules. Click here to learn more.

FOCUS ON FILL-FINISH

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Overcoming Challenges In CGT Development

Explore connector solutions for sterility, chemical compatibility, and ultra-low temperature challenges when setting up a therapeutic process for long-term success.

How To Reduce Five Key Risks In Fill and Finish

Explore how automation and best-practice solutions can help cell therapy manufacturers de-risk their fill and finish process.

Vial Containment Systems Based On Elastomer 4031/45 Gray

For a properly-assembled vial containment system, good container closure integrity performance can be achieved with stoppers of a given elastomer, independent of configuration.

FILL-FINISH SOLUTIONS

Mini/Maxi Flange Gaskets - Nordson MEDICAL

Flexible Manufacturing Solutions, Services To Meet Evolving Needs - Jubilant HollisterStier

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