Newsletter | March 8, 2024

03.08.24 -- Driving Pharma/Biotech Capacity With Smart Manufacturing

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What analytics technologies, tools, and instruments do biopharma developers consider requisite in the buildout of a modern biologics/ATMP, manufacturing facility? How are those tools enabling the analytics and controls that are requisite to continuous manufacturing and advancing the industry toward “biopharma 4.0?” Join Bioprocess Online Live March 27th to find out! Registration is free thanks to the support of Culture Bio.

FEATURED EDITORIAL

Driving Pharma/Biotech Capacity With Smart Manufacturing

Biomanufacturers must consider a new approach to capacity management to resolve today’s challenges and drive innovation and resilience in the future. Here are three ways smart manufacturing can help.

INDUSTRY INSIGHTS

Overcoming Cell Line Development Challenges With Early-Stage Processes

The biopharmaceutical industry is trending toward building process characterization systems and processes early in a project’s life cycle, enabling success for later-stage development.

An Introduction To Laminar Airflow Technology In Aseptic Processing

Explore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.

CMO As Partners For ADC Process Development, Scale-Up, Optimization

ADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

Following The Science To Develop Best-In-Class Cancer Drugs

As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.

Break Free From The Protein A Low-Productivity Paradigm

Protein A resins, with low flow rates and mass transport, lead to low productivity. Discover a solution that removes the bottleneck, offering a disposable alternative for mAb capture.

N-Glycan Characterization With LC-MS

Glycosylation, a prevalent modification of mAbs, significantly impacts their function. Delve into various techniques for analyzing released glycans and their relative efficacy in HILIC-FLR-MS.

The Business Case For Pharmaceutical Continuous Manufacturing

Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.

What Are The Five Key Differences Between A Good CDMO And A Great One?

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage short-term needs while anticipating and planning for long-term requirements.

Future-Proofing The Cell And Gene Therapy Supply Chain

Uncover guiding principles to ensure that your CGT supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

Leveraging Transposase Technologies To Optimize Cell Line Development

Enable a wide array of genomic manipulation with the more regulated and efficient genomic insertion that's made possible by transposase-based technologies.

Are Non-Human Primates A Research Dead End?

The time has come to move away from using non-human primates as test subjects in biomedical research and embrace more practical, reproducible, and cost-effective models.

Real-Time Live Cell Imaging In Successful ADC Development

Learn how the visualization of critical cellular responses can enable live-cell imaging to indicate effective payload delivery, increasing the potential of identifying clinically viable ADC leads.

PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns here.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

The pros and cons of soluble and insoluble processes: isolating, solubilizing, properly refolding, and strategies to improve the performance of IB processes.

Common Challenges And Solutions Of Equipment Ownership And Use

There are many factors to consider when tasked with acquiring the equipment needed to run a pharma facility. Being aware of every up-front cost is a must when determining optimal equipment ownership.

Serum-Free Culture Of Vero Cells In The Corning CellCube System

Review our work to establish a protocol for culturing Vero cells in serum-free medium on the Corning CellCube System, a compact and scalable method for mass culture of attachment-dependent cells.

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Webinar: De-Risking The Development Of Tomorrow’s Medicines With Advancing Analytical Characterization Capabilities

Join industry leader Jason Barker for a presentation on the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver tomorrow’s medicines in a safe, compliant, and efficient manner. Click here to learn more.

SOLUTIONS

Purify Specialized mAbs

Pharma+ Tubing Retainers

Hyclone Cell Culture Serum Products

Single-Use Chromatography System For Scale-Up Flexibility

Analytical Assay Development And Qualification

EndonucleaseGTP ELISA Kit

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