Newsletter | September 18, 2023

09.18.23 -- Mechanistic Modeling To Optimize rAAV Production For Gene Therapy


Given the complexity of mRNA, rigorous characterization and testing are required to ensure safe and effective mRNA drug products. This white paper provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products. Learn more.


Commercial Readiness with Orca Bio's Dan Kirby

Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.

Mechanistic Modeling To Optimize rAAV Production For Gene Therapy

Current processes in recombinant adeno-associated virus-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and anyone can use it to test a wide range of conditions and hypotheses.


Protein Capture Devices With Protein A: Improve Purification Times

This protein capture device demonstration showcases a cycling protocol that uses fast loading and non-loading residence times as well as a rapid CIP out to 100 cycles.

Top 5 Considerations When Making Decisions For A More Robust Harvest

Learn how to achieve a robust and environmentally friendly harvest process with lower operational costs using robust single-use innovations.

Support Of Nanoparticles For Gene Therapy, Immuno-Oncology, And Vaccines

The surge in demand for nanoparticles to manufacture COVID-19 vaccines has paved the way for new innovations and investments, representing a unique opportunity for stakeholders in the space.

Considerations For Sterilization Of Single-Use Assemblies

Compare sterilization methods for single use assemblies and determine which is best suited to meet the needs of your operations and final product.

Addressing Cell Line Development Bottlenecks

Explore study results demonstrating the ability of a specialized reagent to substantially improve the cell line development workflow cloning phase for the manufacture of protein biologics and viral vectors.

Reaching First-In-Human Trials Faster: Connect With The Right Partner

Assessing the credentials of outsourcing partners in people, technology, supply chains, and integration will make all the difference as sponsors aim to mitigate risk and streamline the path to commercialization.

5 Key Factors For Reliable Screening Results In Incubation Shakers

Read through five examples of how the right screening equipment helps achieve better results and avoid picking the wrong candidates.

Stem Cell Cultivation In Single-Use Stirred Tank Bioreactors

Explore a study aimed at achieving clinically relevant cell numbers using the engineering of a GMP-compliant large-scale platform.

Gene And Cell Therapy Analytical And Development Methods

Explore the importance of implementing development approaches early in the product life cycle and how analytical method choice impacts the production of safe and efficacious gene and cell therapies.

LNP Formulation For mRNA Delivery

Microfluidic mixing is one of the most effective means to formulate lipid nanoparticles (LNPs). Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.

Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

What sustainable manufacturing processes best address oligonucleotide environmental impact while maintaining scalability?

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery, along with potential strategies to address these issues.

Your Capital Equipment Project Is Cancelled: Now What?

Late-stage clinical trial failures usually result in exposure regarding capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment?


The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision makers in the industry to advance cutting-edge research into cures. This year’s program will feature expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by the leading publicly traded and privately held companies in the space. Register today.


Multiparameter Information On Conformational And Colloidal Stability

Flexible And Agile Biomanufacturing Solutions

Single-Use Film Engineered For Superior Strength And Leak Resistance

Uniform-Sized Polystyrene Latex Particles For Immunodiagnostic Reagents

QX ONE System Control And Analysis Software

KAPA3G HotStart DNA Polymerase: Evolved To Excel

AseptiQuik W Series Assembly Process

Analytical Development


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