Newsletter | October 4, 2024

10.04.24 -- Capacity, AI Driving Single-Use Bioprocess Probe And Sensor Uptake

NEW PODCAST EPISODE

Biotech Course Correction With Treehill Partners' Ali Pashazadeh

It wouldn't be accurate to say that surgeon-turned-healthcare investment banker and consultant Dr. Ali Pashazadeh traded his scalpels for spreadsheets. In fact, he still wields a scalpel quite frequently, and on the Business of Biotech podcast, he offers a fantastic reason why. Whether you're a biotech builder in the throes of disruption, or feeling lucky that you've been threading scientific, clinical, capital, and regulatory needles all along, this episode offers a ton of insight.

FOCUS ON FACILITIES DESIGN

Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake

Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models.

FOCUS ON FACILITIES DESIGN

Advanced Therapy Manufacturers' Checklist For Cleanroom Project Success

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Increasing Manufacturing Workspace Efficiency In Biopharma

Surplus and idle equipment can lead to decreases in workspace and work efficiencies for a manufacturing site. Learn how you can get paid for them and clean up your workspaces.

Unstoppable Critical Cleaning To Increase Pharmaceutical Throughput

Process optimization is key to achieving effective pharmaceutical and cosmetic critical cleaning. Learn how manufacturers can improve cleaning efficiency and ensure product safety.

6 Reasons To Use Biological Indicators During Your Sterilization Cycle

Explore the importance of biological indicators and why they should be integral to any comprehensive sterilization program.

Optimizing Drug Development Through Customized CMC Solutions

Tailored CMC services can lead to shorter global licensing timelines and minimize variability in globally registered product details.

FACILITIES DESIGN SOLUTIONS

KUBio Box Modular Environments For Biomanufacturing Capacity - Cytiva

Cleaning Hormone Residues - Alconox Inc.

Alachua Biomanufacturing Expansion - Resilience US, Inc.

FOCUS ON PROCESS ENGINEERING

Accelerate CMC Development With Team Topologies

A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.

Looking To Maximize Efficiencies During Process Development?

Discover how single-use bioreactors ensure seamless process development to production with consistent yields and quality.

Defining The Necessary Steps In Antibody Development

Explore antibody development and production, the processes and steps involved, and the screening and selection of antibody candidates.

What Do You Need To Know About Analyzing AAVs With Mass Photometry?

This analytical instrument, designed to analyze AAV samples, can precisely determine the empty/full capsid ratio in samples of any serotype in a cost-effective, simple to operate way.

Safe Handling Of Monoclonal Antibodies: Best Practices

Explore safety measures for handling mAbs in production in order to meet strict requirements that prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes.

Building Effective Multi-Year Process Development Programs I: Estimating hMSC Lot Size Ranges

In this blog we outline a development program that could tailor accordingly to meet your final product platform needs, with target cell lot size foremost in mind.

Navigating Challenges During Formulation Development

Gain valuable knowledge on addressing formulation stability, improving product shelf life, and enhancing overall product performance in biopharmaceutical studies.

Biopharma Drug Development Workflow And Techniques

Drug development is a long and complex process, and every step has specific goals. Explore the relevant objectives and techniques used in each stage of antibody drug development.

Getting CMC Right For Emerging Technologies

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Secure And Industrialize Your CGT Process Towards cGMP Manufacturing

Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.

Embrace Molecule Complexity With Optimized Expression Technologies

Explore the needs of more complex candidates, through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

Developability Assessment Of Three Therapeutic Antibodies

This poster reviews studies for three monoclonal antibody drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

Maximize Equipment Uptime With Comprehensive Maintenance Support

In an industry where unplanned downtime during manufacturing can be catastrophic, having the right maintenance support for the specialized equipment supporting a biopharmaceutical workflow is crucial.

How To Make The Best LNPs

There are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.

PROCESS ENGINEERING SOLUTIONS

Optofluidic And Proteomic Barcoding Platforms - Bruker Cellular Analysis

Accelerate Biologics Development With Electroporation Technology - MaxCyte, Inc.

Technique To Measure The Scattering Contrast And Size Of Nanoparticles - Refeyn

Phase-Appropriate, Tailored Process Development Support - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

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