Newsletter | February 26, 2024

02.26.24 -- How To Use Precipitation, Not Protein A Chromatography, For mAb Capture

FEATURED EDITORIAL

How To Use Precipitation, Not Protein A Chromatography, For mAb Capture

Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.

INDUSTRY INSIGHTS

Choosing A CDMO: Top 10 Intangibles Biotech Firms Should Consider

Selecting a CDMO is a long-term partnership, not just a transactional relationship, and it can impact the success of your current product and benefit the manufacturing of future products.

Unlock The Therapeutic Potential Of MSC-Derived Exosomes

Explore overcoming the challenges of MSC and EV production and how bone marrow-MSC EVs with anti-inflammatory activity are being used to treat retinal degeneration and traumatic brain injuries.

CDMO Expertise Accelerates Biologics Development, Manufacturing

An experienced contract manufacturer can help drug developers to better utilize internal resources, leverage deep industry experience, and mitigate risk across development cycles.

Potency Assays 101: How To Develop A CMC Relative Potency Assay

This e-book dissects the potency assay development process into its key steps, offering a clearer understanding of the journey.

An Introduction And Brief History Of mRNA-LNPs

With adjustable components and increased stability during bloodstream circulation, LNPs are significantly advancing drug development and delivery, particularly for mRNA vaccines.

High Concentration Monoclonal Antibody Drugs Manufacturing Challenges

This is a review of high-concentration mAb manufacturing challenges including viscosity, aggregation, instability, and the effect of excipients on formulation, filtration, fill/finish, and bioavailability.

Accelerate Successful Transfer Of Recombinant Protein Analytical Assays

Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when accelerating the successful transfer of recombinant protein analytical assays.

Engineering CHO K1 Cells With Three Orthogonal Transposase Systems

Transposase-mediated genome engineering enables the robust and stable relocation of discrete DNA segments (transposons) in the genome, providing a valuable tool for stable transgene expression.

In-line Monitoring Of Bioprocess Parameters For The 21st Century

Review the current state of several optical technology approaches and their associated strengths and limitations along with new and transformative means to instantly implement in-line monitoring.

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.

Early Product Characterization De-Risks Biologics Development

The relationship between physicochemical profile and biological activity is key to informed decisions, accelerated development, and risk reduction.

Optimizing And De-Risking With Real-Time, Viable Environmental Monitoring

Real-time, viable environmental monitoring optimizes manufacturing timelines via immediate results, alleviates risks associated with traditional environmental monitoring, and satisfies Annex 1 regulations.

Using A 250-mL Bioreactor For AAV Production

Explore this demonstration of an AAV upstream process in proprietary bioreactors, including an example of using process optimization to increase the fraction of full AAV capsids.

Purification Of DNA Oligonucleotides Using AEX Chromatography Webcast

Explore impurities removed by strong anion exchange chromatography for the advancement of these molecules as therapeutics and a cost-effective, efficient, and scalable purification method.

Empowering A New Era Of Patient-Centric Medicines

Discover the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

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