Newsletter | November 27, 2023

11.27.23 -- Allogeneic Cell Therapy: Our Strategy, Learnings, & Advice

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FEATURED EDITORIAL

Allogeneic Cell Therapy: Our Strategy, Learnings, And Advice

Celularity is a Florham Park, NJ, biotech company developing off-the-shelf placental-derived allogeneic cell therapies. We caught up with Robert Hariri, CEO, founder, and chairperson of Celularity, to discuss the company’s facility site selection strategy and scale-up plans, lessons learned during early development, and more.

Biotech Dealmaking with Regeneron's Nouhad Husseini

When it comes to landing and executing strategic partnerships, Regeneron puts on a clinic. The man behind much of the company's dealmaking is Nouhad Husseini, SVP and Head of Business Development and Corporate Strategy at Regeneron. Learn from the best on this episode of the Business of Biotech. 

INDUSTRY INSIGHTS

Components Of An Effective Disinfectant Prequalification Strategy

Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

Highly Potent Active Pharmaceutical Ingredients Containment

Review a full life cycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

Co-Culture Studies To Decode 'Biological PINs' And Exosomes

This article explains the caution points in exosome study procedures and the co-culture system as an explanatory tool for the purpose of decoding the code numbers in the living body.

Gene Therapies For Better Kidney Treatments With Purespring Therapeutics

Purespring Therapeutics explores the importance of pursuing new treatments for kidney conditions and shares why it's poised for long-range commercial success.

Digitize Pharma Lifecycle Management For Faster Regulatory Filing

Find out how pharma and biotech companies can adopt a proactive lifecycle management approach to address data challenges.

Striking A Balance Of Speed And Quality To Deliver Next-Gen Therapeutics

Successful delivery of a bispecific antibody therapeutic to patients necessitates a manufacturing strategy that can accommodate the unique size, structure, and complexity of these molecules to ensure quality.

New ICH Q14 Guidance Applies QbD To Analytical Procedures

Review the differences between the ICH's new draft guidance (Q14) and the traditional approach. Delve deeper into the potential benefits of the new methodology.

A Smart Path For Novel Biologics

Learn about a solution for streamlining workflow in novel biologics while collecting quality data, by combining single-use microbioreactors with advanced automation and analytical platforms.

The 10 Most Frequently Asked Questions On Glass: Part I

Dr. Bettine Boltres, who supports pharmaceutical companies to address glass-related topics from a scientific perspective, answers the most commonly asked questions she encounters about glass vials.

Challenges In Viral Vector Production And Innovative Solutions

Single-use technology is playing a large role in increasing flexibility and reducing contamination risks for the biopharmaceutical industry. Take a deeper look into all of the advantages and challenges.

Identify Top Producing Clones With Favorable Product Quality Attributes

Examine a workflow that provides a reduction in overall bioprocess costs, shortened timelines, improved cloning efficiencies, and >99% monoclonality assurance.

Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks

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

Ensuring Continuity Of Protein A Resin Supply

Learn about a strong partnership formed to improve the availability and accessibility of vital medicines by maximizing productivity while improving cost efficiency.

N-Linked Glycan Analysis For Complex Glycoproteins

An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high-quality material but had a low yield and was not scalable.

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SOLUTIONS

An Incubation Shaker For Uninterrupted 24/7 Operation

Accelerated mAb Development Program

Best Practices For Evaluating A Perfusion Medium

Simtra BioPharma Solutions Capacity Update October 2023: Biologics

Real-World Experience Training For Industry Success

Single-Use Components For Bioprocessing Applications

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Join The Advancing RNA Community

Introducing Advancing RNA, an online community designed to be a forum and resource for professionals working on RNA-based therapeutics to better understand the challenges that confront them in areas such as analytical/quality, manufacturing, formulation, outsourcing, clinical research, and supply chain/logistics. Sign up for the Advancing RNA newsletter, delivered to your inbox weekly.

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