02.07.24 -- 3 Things You Didn't Hear Coming Out Of JPM

Novel analytical technologies such as ddPCR provide a more rapid and robust approach to nucleic acid quantification for therapeutic development for better sensitivity, accuracy, and precision.

Explore how to achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

As interest in HPAPIs as powerful therapeutic mechanisms continues to grow, drug manufacturers must design thoughtful risk-based containment strategies to protect employees and ensure safety.

In this e-book we explore what ATMPs are, what they can achieve, ATMP fluid management, and ATMP manufacturing challenges, as well as receiving expert answers to common questions.

Review the results of studies into the optimal method for cleaning and sterilizing a multiuse bioreactor, headplate, tubing, vent filters, liquid media, and filled liquid addition bottle.

Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

Thermal stability is one of the most common critical quality attributes of therapeutic proteins. Learn about four methods for thermal stability assessment of proteins.

As demand for high-potency active pharmaceutical ingredients (HPAPIs) rises, ensuring your company utilizes specialized facilities with HPAPI handling capabilities is crucial.

Even the strongest study design may encounter issues with achieving sufficient clearance. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

Achieve a more physiologically relevant setting with less reliance on model animals when studying diseases such as cancer through the combination of CRISPR screening and bulk spheroid production.

Examine whether you've done all you can as early as possible to minimize errors, reduce contamination risks, and speed up processing time to save unnecessary, non-value-added expenses.

Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.

Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

If you think of a construction turnover package (TOP) plan in industrial projects as optional, think again. Learn how to manage and execute TOPs to achieve operational readiness.