02.20.26 -- Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing

New alternative phosphitylating reagents reduce the safety hazards associated with BCDP, enabling a safer and effective synthesis of key oligonucleotide sequences.

Discover how modern strategies like the CCS are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative methods.

This guide ranks fluorochromes, offers pairing strategies, and provides practical tips for designing high-quality, multiparameter assays with clear population separation in your flow cytometry panels.

Examine how early identification of CQAs can streamline mRNA drug product development, reduce risk, and align with evolving regulatory expectations.

Effectively managing process parameters and quality attributes is vital for successful drug development. Find out how a Quality by Design approach can optimize your processes and ensure product quality.

Uncover how light scattering reveals the structural integrity, aggregation, and stability of GLP-1 analogs to advance drug formulation and enhance treatment efficacy for type 2 diabetes and obesity.

Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Read about six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

Like a referee in a contest, advanced analytical methods are essential to mediate the push and pull of different factors influencing therapeutic efficacy.

Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Master the fundamentals of identifying and monitoring process-related impurities. Ensure biologic safety and regulatory success by optimizing your analytical strategy.

Cell and gene therapies are reshaping life sciences. See how quality can transition from a compliance role to a strategic partner, enabling innovation and growth during this transformative period.

Discover the need for organizations to modernize Quality Management Reviews (QMR) through digital tools and analytics to enhance efficiency, collaboration, and continuous improvement.

Explore a data-driven approach to strain engineering using a Pseudomonas fluorescens platform, which leverages a diverse molecular toolbox to bypass common bottlenecks in protein expression.

Partnering with a CDMO that demonstrates innovative and commercially validated cell line development capabilities is essential to protecting your market position and securing investor support.

Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.

Syngeneic mouse tumor models are crucial for immunotherapy, but variability in TILs and nonspecific binding complicate analysis. Review how blocking reagents help make the process more labor-intensive.

Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services.

Explore how manufacturers can turn sustainability challenges into strategic advantages through smarter energy use, regulatory insight, and emerging innovations.

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

While practical quantum computing applications remain far away, quantum biosensing applications with real-world impact in areas like immunotherapy and diagnostics are near at hand.