01.16.26 -- Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry

Learn how rational design and optimized feed strategies enable high-titer protein expression and full incorporation of non-canonical amino acids at scale, overcoming common toxicity and yield bottlenecks.

Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

Learn how to implement a validated, broad-spectrum qPCR workflow that covers over 250 species, ensuring both regulatory compliance and accelerated speed-to-market for your clinical-grade products.

See how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.

The ISABEL trap, which deploys interferometric scattering as a highly sensitive, fluorophore-label-free detection scheme, enables precise interpretation of the actions of complex biomolecular nanoparticles.

Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.

Gain insight into how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

Airborne microbial contamination is a serious concern for companies producing medicines and biotech products, and it must be addressed to ensure that products and people are kept safe.

Explore how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

Unlock expert strategies for navigating the complex downstream purification and process challenges inherent in developing next-generation antibodies. Design for scalability from the start.

Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development.

Examine the results collected when a platform designed with ML-guided GPS engineering was applied to develop a lead molecule targeting a mechanism in neuronal disease.

In-process and quality control ensure consistent manufacturing of gene-engineered hematopoietic stem cells. Observe an engineering process that enhances production through viral transduction.

AAV therapies require high quality and high titers of viral genomes per dosage, prompting the need for a more efficient AAV manufacturing method to reduce overall costs.

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.