Newsletter | August 29, 2025

08.29.25 -- How AI Is Revolutionizing Quality Management Systems

SPONSOR

Webinar: Assessing Production and Stability for Current and Emerging Antibody Drug Conjugate platforms

Discover how formulation differences impact Antibody-Drug Conjugates (ADCs) in this TA Instruments webinar. Learn essential techniques—mass spectrometry, peptide mapping, infrared spectroscopy, DLS, DSC—to evaluate ADC stability, structure, aggregation, and drug-to-antibody ratio. Using trastuzumab with varied payloads, see how these tools apply to current and emerging ADCs. Register now to gain practical insights for your research! Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

How AI Is Revolutionizing Quality Management Systems

The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

Redefining Process Design And The Evolution Of Critical Process Parameters

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

Pushing Boundaries In Biophysics And Biomanufacturing

Gain valuable perspectives on the future of biomanufacturing, including the impact of data science, automation, and continuous learning, shared by an experienced biophysics specialist in the field.

Improved Viable Particle Discrimination With Real-Time Particle Counter

A new algorithm developed by a real-time viable particle counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.

The Advantages Of A Blended Learning Approach In Operator Training

Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

Analytical Development Services

Understand the basic principles of analytical development for cGMP assays and the assays that are generally relevant to major biopharmaceutical modalities.

PAT: Out Of The Dark Ages

Process Analytical Technology (PAT) is essential for efficient process development, but its implementation requires user-friendly, automated solutions that provide actionable information for scientists.

A Guide To Optimize Analytical Strategies In Biologics Development

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations also lack appropriate resources to create optimal testing methods and protocols.

Three Key Strategies To Guide Efficient And Effective Recall Management

Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

Thermal Stability Of Phosphoramidites In Oligonucleotide Synthesis

Crucial for efficacy, thermal stability in RNA/DNA therapies hinges on phosphoramidites: A study highlights key factors for process safety and quality in oligonucleotide development.

Improve Scalability And Manufacturability Of A Cytotoxic ADC

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

AI Implementation To Enhance Quality

AI is enhancing regulatory compliance, quality assurance, and operational efficiency in biopharma. Here, we exemplify how AI-driven solutions drive innovation while maintaining alignment with best practices

Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis

Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.

Column Selection For RPLC-UV Impurity Analysis

Explore the performance of four column chemistries for RPLC-UV impurity analysis of liraglutide and semaglutide, which offers practical guidance for method development in peptide-based therapeutics.

Variant-Aware Therapeutic Guide Selection

Learn about a technology that identifies CRISPR guide RNAs with minimal off-target effects for gene editing by screening thousands of genomes and incorporating genetic diversity across populations.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Live Cell Metabolic Analyzer - PHC Corporation of North America

Why Choose The Identifier Software? - InQuest Science

Microcalorimetry: RS-DSC, DSC & ITC - TA Instruments

Confocal Microscope Platform - Danaher Life Sciences

FOCUS ON REGULATORY

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape. Learn about new required tests and instrumentation for compliance and recommendations on method implementation.

AOCs: Strategies For Chemistry, Manufacturing, And Regulatory Success

Gain valuable insights from industry experts on overcoming the unique chemical, technical, and regulatory challenges of AOC development by watching the recorded webinar.

Direct Quantification Of Residual Host Cell DNA

Residual host cell DNA monitoring is vital in biologics manufacturing. Learn how digital PCR offers sensitivity and precision to ensure compliance with safety standards set by global regulatory agencies.

Gene And Cell Therapy: Planning For Manufacturing Success Early

As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.

REGULATORY SOLUTIONS

A Leading Digital Validation Platform For Life Sciences - Kneat Solutions

Your Global Partner In Pharmaceutical Contamination Control - Particle Measuring Systems

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