04.09.25 -- Alternatives To Testing Sterility In Cell- And Tissue-Based Products

While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements.

Explore critical steps and key regulatory requirements for developing CRISPR therapeutics and gain practical advice on how to avoid common pitfalls.

Know the differences between designing a viral clearance study for non-enveloped viral vectors versus those for mAbs or recombinant proteins, and learn how to identify and remove viral contaminants.

Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

Single-use technology suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain the safety and efficacy of new treatments.

Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision, efficiency, and regulatory pathways for next-generation genetic medicines.

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.