Newsletter | June 13, 2024

06.13.24 -- Assassination By Implication? Interview With WuXi AppTec (Part 2)

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Webinar: Balancing the scales: The ups and downs of bioprocess scale-up – insights from a leading CDMO

Delve into the complexities of scaling decisions. We’ll offer insights from both biopharma developers and a CDMO. Learn about their mutual interest in achieving successful scale-up and gain valuable strategies for avoiding common pitfalls. You’ll also hear about Lonza’s facility investments and scaling expertise designed to help you find your optimal scale. Click here to learn more.

FEATURED EDITORIAL

Assassination By Implication? Interview With WuXi AppTec (Part 2)

“As you read these accusations, it’s like an attempted death by a thousand implications,” says Rick Connell, former Pfizer supply-chain executive and current WuXi AppTec President, U.S. and Europe. In this part two, he provides a line-by-line analysis of the BIOSECURE Act targeting his company.

Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?

Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

INDUSTRY INSIGHTS

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

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

Novel Lipid Nanoparticle Delivery Reagent And Manufacturing Workflow

Discover how commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.

Effective Vaccine Development In The Face Of A Future Pandemic

CDMOs are playing a critical role in preparing for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

Plan Your CDMO Search On A Foundation For Long-Term Success

Capacity constraints typically are accompanied by other challenges, including missed timelines, defect rates, and overall decreased satisfaction with companies’ bioprocessing CDMOs.

Improving Safety And Efficacy With Charged Variant Characterization

A CDMO with experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

The Critical Role Of Comparative Analytical Assessments

Learn how utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

SOLUTIONS

Providing A De-Risked And Streamlined Development Pathway

At Abzena, the leading CDMO + CRO for complex biologics and bioconjugates, our focus is on providing a de-risked and streamlined development pathway for our customers.

Transport Simulation Laboratory (TSL)

The TSL consists of a large environmental chamber equipped with a control system, calibrated sensors, and a validated data collection system with mechanical and hydraulic equipment that can simulate a customized distribution environment profile.

Modular Chromatography System For Liquid Chromatography

The BioProcess™ Modular System can be configured to meet specific downstream process demands. It has the accuracy and documentation required for use in GMP-regulated environments.

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.

Connect With Outsourced Pharma: