Newsletter | October 14, 2025

10.14.25 -- Leveraging Contamination Control Strategies For A Competitive Advantage

SPONSOR

Webinar: Leveraging Integrated DS/DP Manufacturing to Mitigate CMC Risks and Simplify Commercial Supply

Discover how Lonza's integrated CDMO model unites drug substance and drug product manufacturing to drive efficiency and quality. In this webinar, experts share real-world lessons from complex biologics programs, highlighting streamlined tech transfers, shared quality systems, and cross-functional collaboration. Learn how early alignment and proactive problem-solving accelerate timelines, ensure regulatory readiness, and deliver successful commercial outcomes. Click here to learn more.

FOCUS ON OUTSOURCING

How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage

It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.

Analyzing The Need For An Engineering Run: A Risk-Based Decision

Executing or skipping an engineering run is a consequential decision for any biopharma or CDMO and should be supported by all available data as well as a thorough risk assessment.

Nanoforming Biologics, GLP-1s: From I.V. To Sub Q And Inhaled Delivery

Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.

Enabling Digital Twins With Computational Fluid Dynamics Modeling

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.

Utilizing Fed-Batch Intensification To Increase Titer In Biomanufacturing

Learn how the advanced principles of process intensification can be applied to process and equipment design, increasing facility throughput, and ultimately offering a wide range of benefits to customers.

Accelerate And Enhance Biomanufacturing Operator Training

Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.

5 Advantages Of Dual-Sourcing In Pharmaceutical Fill/Finish

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

Accelerate And De-Risk Bioconjugate Drug Development

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

An Industry-Backed Approach To Container Closure Integrity

Ensuring container closure integrity in an increasingly complex pharmaceutical industry requires a holistic approach that incorporates quality control into all phases of product design and development.

Addressing Complex Challenges And Developing Innovative Solutions

Explore two projects that a focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

Pioneering Scalable Solutions In AAV Manufacturing And Testing

Learn how pharmaceutical and biotech companies can leverage cutting-edge technology to bring transformative gene therapies to market, making treatments more readily available to patients worldwide.

Leveraging Novel Analytical Approaches For Advanced Therapies

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Optimizing Cell Line And Process Development Workflows

Process development experts discuss how advanced cell line development and transposase technology streamline the path to toxicology and first-in-human studies.

SPONSOR

AAPS PharmSci 360 delivers research spanning the pharmaceutical pipeline, from discovery to manufacturing to delivery. Thousands of scientists and decision-makers from across the globe converge to discuss cutting-edge breakthroughs, technologies, and techniques at this science-first event. Join your colleagues for the latest in pharmaceutical science in San Antonio, Texas, November 9-12, 2025. Register today!

OUTSOURCING SOLUTIONS

Making Success More Certain - Bora Pharmaceuticals

Biologics Discovery, Development, And Manufacturing - Curia

Organoid-Based Drug Screening Services - Samsung Biologics

mRNA/LNP Development And Manufacturing Services - Lonza

Step Inside One Of America's Leading Protein Biologics CDMO Sites - AGC Biologics

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