Newsletter | December 3, 2021

12.03.21 -- The Two Emerging Fields Propelling The Use Of AI In Precision Medicine

Featured Editorial
Industry Insights
Bayer Evaluates Fibro For Scalable Single-Use Monoclonal Antibody (mAb) Purification

Learn how Bayer evaluated Fibro PrismA chromatography to determine its potential as a true single-use mAb capture technology. They assessed scalability from lab- to process-scale tracking pressure drop, step recovery, purity, and eluate volumes across multiple cycles. Read the outcome here.

5,000 L Single-Use Bioreactors: Next-Gen Biologics Manufacturing

A new generation of single-use bioreactors, built to deliver high-volume performance, addresses a demand for therapeutics, expanding indications for biologics, and a growing portfolio of biosimilars.

Utilize Modular Cleanrooms To Reduce Your Risk Of An FDA Form 483 Violation

Maintaining FDA compliance is essential to your business operations, and downtime of any sort could derail your business and potentially harm patients. A cleanroom facility that remains safe for your workers — and ensures that the therapeutics they produce remain safe for patients — can ease your compliance concerns.

Factors That Influence Methods To Measure Product Resistance
Product resistance (Rp) is the resistance to vapor flow through the dried layer out of the vial during primary drying. Along with vial heat transfer coefficient (Kv), product resistance is a key determinant of temperature.
Recapitulating The Multifaceted Inflammatory Environment Of The Intestine In Vitro

Intestinal inflammatory diseases are highly complex, which has thus far prevented development of an effective in vitro disease model. With access to a donor-derived cell biobank and the ability to recapitulate region-specific environments of the intestine, Altis Biosystems is working toward the development of an in vitro RepliGut model to accurately recapitulate the complex intestinal inflammatory microenvironments.

Looking Back And Moving Forward In The Fight Against COVID-19

In a recent roundtable discussion, a panel of experts offered their insight on what challenges they have seen during this crisis and what they believe we can learn from them going forward.

Do Strategic Partnerships Meet Outsourcers Expectations?

ISR’s CDMO Outsourcing Models report dives into three approaches to contracting manufacturing work, the motivations behind them, and which methods earn the greatest satisfaction among users.

The Value Of Expertise In The Aseptic Fill/Finish Of Biologics

Aseptic fill/finish manufacturing is especially critical for highly valuable biologics drug substances, since with vast amounts of time and resources invested upstream, any errors resulting in loss of product at such a late stage can be catastrophic.

Increase Production Efficiencies With Single-Use Transfer Lines

Biopharmaceutical manufacturers are implementing new ways to leverage existing plant infrastructure to enhance process reliability and flexibility. One solution that continues to gain momentum is single-use systems — particularly single-use transfer lines — which can deliver significant value through added flexibility, improved asset/equipment utilization, and increased cost savings.

Bulletproof Your Supply Chain: Hope For The Best, Prepare For The Worst

Explore how to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how to use a risk-based approach to determine where a contingency plan is needed.

Developing Effective Procedures In Drug Manufacturing

This paper explores the change management, risk management, and knowledge management processes and how they integrate with one another to help you construct proper procedures for your organization.

Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids

Maximized uptime, minimized changeover time, and efficient overall equipment effectiveness (OEE) are key factors that have influenced the acceptance of aseptic blow/fill/seal in the packaging of pharmaceutical liquids.

Mixing And Blending Strategies For Emulsified Vaccines

To produce a stable water-in-oil (W/O) emulsified vaccine with maintained immunity-inducing properties, the manufacturing process must achieve small emulsion droplets (<1 µm) with a monomodal and narrow particle size distribution. The use of high-shear energy provided by a rotor/stator mixer is required to reach this target.

Data Matrix Codes And Tamper-Evident Seals Help Pharmaceutical Company Ensure Quality And Prevent Falsification
The midsize pharmaceuticals company Krewel Meuselbach GmbH manufactures top-quality, affordable pharmaceuticals using state-of-the-art technology. For traceability and prevention of product falsification, Krewel Meuselbach uses the compact XS2 MV TE system in a thermoforming line to ensure comprehensive quality control and prevent the falsification of its products. It achieves this through data matrix codes and tamper-evident seals.
Evolution Of Flexible Commercial Biologics Manufacturing

Are you achieving optimal flexibility in your biologics development and manufacturing by effectively leveraging the most advanced technologies?

Streamlined Selection Of In Vivo Predictive Dissolution Media

Explore the design of dissolution media to support biopredictive dissolution testing and a method for selecting practical, physiologically relevant media based upon drug, formulation, and GI fluid properties.

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