Newsletter | April 11, 2025

04.11.25 -- Using Digital Shadows To Reinforce Downstream Modeling

SPONSOR

The debate rages on. While the automation that enables continuous processing gets a lot of hype, there are plenty of dyed-in-the-wool biopharma pros who contend that process optimization and intensification yield comparable benefits, without requiring the capital-intensive process overhaul that continuous demands. Join Bioprocess Online Live for a virtual deep dive into the scalability, sustainability, and capital implications of the continuous-versus-optimized debate. Registration is free thanks to the support of Cytiva.

FOCUS ON PROCESS ENGINEERING

Using Digital Shadows To Reinforce Downstream Modeling

This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.

Best Practices To Adapt And Improve Quality Control Programs For CGTs

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

Building A Do-It-Yourself Quantum Scanning Microscope

A DIY quantum scanning microscope is a viable option for users who prefer to modify the experiment setup or cannot reserve adequate time on a shared instrument.

Solid State Hydrogen Deuterium Exchange To Study ADC Stability

Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.

Engineering An AAV Platform For Superior Titer And Capsid Integrity

Learn how to optimize AAV manufacturing with a transfection reagent and enhancer platform that boosts titers and percent full capsids by 2- to 10-fold, featuring insights from real-world case studies.

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Characterizing The Effect Or Functions Of Therapeutic Antibodies

Understanding the Fc region of your antibody is crucial for assessing the impact on immunology, safety, and efficacy. Explore how to determine the most efficient way to test functionality.

The Current And Future Value Of mRNA Vaccines And Therapeutics

Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.

The Critical Role Of Weight Uniformity In Tablet Manufacturing

For tablet manufacturers, tablet weight uniformity plays an essential role in ensuring pharmaceutical products deliver accurate amounts of key ingredients in a formulation.

The Importance Of Operator Equipment Training

Learn why a strong commitment to operator training is essential to prevent production issues, ensure product quality, and safeguard patient safety.

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

Review a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Mastering Complexity: Strategies For CMC Development And Optimization In The Production Of Multi-Specific Immuno-Cytokines And Fusion Enzymes

Discover how implementing a strategic approach to optimize the platform can establish a solid foundation for the efficient, reliable, and successful manufacturing of biopharmaceutical products.

Complexities And Pitfalls Associated With cGMP Tissue Sourcing

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Formulating A Biologic: Frequently Asked Questions

Explore the vital role of drug formulation in transforming biologics into patient-friendly therapies, and uncover key insights into this critical process from lab to clinical trials.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

PROCESS ENGINEERING SOLUTIONS

Process Development Services - RoosterBio

Antibody Production: Scale-Up Menu - Cytiva

NanoImprove Your Small And Large Molecule Formulations - Nanoform

SPONSOR

Webinar: Sterile Gas Filtration and Optimization in Bioprocessing

This webinar will explore the role of sterilizing-grade gas/vent filters in bioprocessing, highlighting their function as sterile barriers using hydrophobic membranes. Join Entegris as they address challenges like premature fouling and key factors affecting performance, such as flow rate, membrane type, and system design. Their experts will discuss optimizing filter selection to enhance efficiency, cost-effectiveness, and scalability in critical bioprocessing applications. Click here to learn more.

FOCUS ON SUPPLY CHAIN

4 Ways To Prepare For A Fetal Bovine Serum (FBS) Shortage

To prepare for an FBS shortage, secure reliable suppliers, validate backups, stock reserves, and consider alternative sourcing. Corning offers high-quality FBS and expert supply planning support.

Single-Use Assembly Capabilities To Keep Pace With Biopharma Dynamics

Discover how a vendor-independent partner assists global life science companies and CDMOs with innovative single-use technologies to mitigate risks and ensure uninterrupted manufacturing.

Reduce Contamination Risks When Storing Synthetic DNA

An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.

New Container Protects Bulk Frozen Biopharmaceuticals

Learn more about a flexible freeze container that maintains package integrity after freezing at -86 °C. 
(-123 °F) through its durable design, minimizing product loss due to package failure.

Connect With Bioprocess Online: