Newsletter | October 3, 2024

10.03.24 -- A Supply-Chain Woman Of Iran

SPONSOR

Breaking Barriers: Combining Cell Line Development Innovation with Improved Process Development Workflows to Streamline Path to FIH

This webinar will focus on how KBI Biopharma's SUREtechnology Platform™, powered by Selexis®, enables rapid advancement of new complex biologics from early development to first-in-human (FIH). Register to learn how the integration of the SUREtechnology Platform™ accelerates the creation of high-performing, stable cell lines tailored for biologics production. Learn more here.

FEATURED EDITORIAL

A Supply-Chain Woman Of Iran

Arezou Mehrabi presents a spellbinding supply-chain case study set in Iran, involving major challenges in outsourcing to a CDMO for a top-10 pharma (Sanofi). She took leadership in a male-dominated workplace, country, and region.

This Digital Twin Approach Aims To Optimize ATMP Production

Manufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.

INDUSTRY INSIGHTS

Manufacturing Challenges With High Concentration Biologics

Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

Biomarker Selection And Measurement In Neurodegenerative Trials

Biomarkers are vital for early neurodegenerative disease diagnosis. Learn about key protein biomarkers, clinicopathologic correlations, and measurement strategies.

Optimizing Production: The Key To Enhancing Yield, Quality In BsAb

Regarding bispecific antibody (BsAb) manufacturing, a well-optimized culture environment is essential for achieving high and consistent BsAb yields with the desired critical quality attributes.

Challenges And Solutions For Viral Product Development, Manufacturing

To execute complex viral product manufacturing, a service provider needs expertise in adherent cell culture capabilities, cell line productivity, and the intricacies associated with these products.

The Advantages Of N-1 Process Development For mAb Development

Uncover how N-1 process development can lead to significant improvements in mAb production processes and review considerations for successfully implementing N-1 process development.

Integrated Cell Line Development With High Producing Stable Pools

See how this integrated CLD approach, combined with cutting-edge technologies, can drive program success and accelerate the development of protein-based therapeutics.

5 Advantages Of Dual-Sourcing In Pharmaceutical Fill/Finish

Consider the advantages of dual-sourcing in pharmaceutical fill/finish and how this approach can bolster supply chain resilience, increase capacity, and accelerate commercialization.

Navigating Bioconjugate Development

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, address the complexity and uncertainty in bioconjugates.

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.

SPONSOR

Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

SOLUTIONS

Biologics Analytical Services

With extensive experience and capabilities, we foster a collaborative environment, developing and implementing innovative analytical methods to address our partners' testing needs.

How bYlok Technology Enhances Bispecific Production

Review how bYlok technology can drive correct heavy-light chain pairing to >95% and how you can access it via a license agreement to overcome industry-wide challenges.

Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

Unearth how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline.

Advancing Vaccines From Preclinical Development To Commercial Supply

We are an established leader in advancing vaccines from preclinical development to commercial supply across multiple modalities.

ATON Bio Capacity Update July 2024: Large Molecule Development

Gain insights into boosting efficiency, fostering innovation, and how integrated capabilities generate value for innovators.

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.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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