Newsletter | July 24, 2026

07.24.26 -- What To Do About Process Drift In Your Biosimilar's Reference Product

SPONSOR

Webinar: From Data to Decisions: AI and Multi-Omics for Cell Culture Development

Discover how AI and multi-omics are transforming cell culture optimization. In this webinar, Thermo Fisher Scientific experts explore how integrating biological data, predictive modeling, and deep process knowledge can uncover the drivers of productivity and product quality. Learn practical strategies for overcoming optimization plateaus, identifying improvement opportunities, and accelerating media and process development through data-driven, mechanism-based decision-making. Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

What To Do About Process Drift In Your Biosimilar's Reference Product

Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.

Fluorescent Western Blot Detection

Review this step-by-step guidance for fluorescent western blot detection, including membrane prep and antibody handling, to improve signal clarity and consistency across imaging platforms.

Accelerating Innovation With Unified Quality

Centralizing data in a unified cloud QMS eliminates manual tracking, enhances operational visibility, and unlocks predictive insights to bring therapies to patients faster.

Analytical Performance Evaluation Of A Bead-Based Cytokine Assay

Reliable IFN‑γ measurement is critical for understanding T cell function. See how analytical rigor, from accuracy to matrix effects, supports consistent cytokine quantification across development.

Lead Identification And Optimization For Computational Drug Discovery

AI-generated Fab molecules promise speed, but can computational designs actually express and bind at scale? A high-throughput screening workflow offers a data-backed answer.

Bridging The Gap Between Product Readiness And Equipment Availability

Discover how manual precision at scale bridges packaging gaps, accelerates product launches, and ensures uninterrupted supply to deliver quality when automated equipment isn’t yet operational.

A Versatile Analytical Approach To Cleaning Validation

ADCs combine monoclonal antibodies, linkers, and potent cytotoxins, requiring highly sensitive analytics, stringent cleaning validation, and flexible platforms to manage complexity and risks.

Navigating Governance For Quality Assurance And IT Compliance

Agentic AI can speed decision‑making, but only with strong governance. Learn how private deployments and governed data sources enable safe, compliant use without compromising quality.

Sample Quality Control In Next-Generation Sequencing Workflows

Find out how automated electrophoresis and key integrity metrics strengthen NGS workflows by improving sample assessment, streamlining QC steps, and supporting confident decisions.

Analytical Tools To Address The Development Of GLP-1 Receptor Agonists

GLP-1 receptor agonists are revolutionizing therapeutics beyond diabetes. Explore analytical innovations that ensure safety and efficacy as these peptides expand into multiple treatments.

Developing A Method To Assess Product And Personnel Safety

Examine how ultra-sensitive spectroscopy transforms decontamination validation, revealing hidden efficiencies that safely cut facility downtime while ensuring absolute safety.

The Science Of Ion Pair (IP)-Reversed Phase (RP) Oligonucleotide Analysis

Master oligonucleotide separation by balancing hydrophobic and ionic interactions. Observe how selecting the right cationic pairing agent optimizes retention and ensures compatibility with workflows.

Prioritize Clean Fluorochromes And Simplify Panel Design

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.

From Day One Success To Everyday Improvement: The OR → OE Continuum

Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Transform early readiness metrics into a durable operating system that drives continuous improvement.

A Risk-Based Approach To Column Maintenance

Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

The Ultimate Guide To Microplate Reader Solutions

Evaluating microplate readers involves identifying your needs. Take a look at how to select the right reader for your research by choosing single-mode for specific tasks or multi-mode for versatility.

Successfully Navigating Opportunities With On-Body Delivery Systems

Drawing on insights from the regulatory landscape, trends, and feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.

QUALITY/ANALYTICAL SOLUTIONS

Comprehensive mRNA Sequencing With Integrated Quantification - Tecan

Organoid-Based Drug Screening Services - Samsung Biologics

Life Sciences Partner For High-Purity Chemicals And Custom Solutions - Greenfield Global

Biologics Analytical Services - Catalent

SPONSOR

Webinar: The Future of Cell Culture Media Development: Predictive Modeling and AI

Discover how predictive modeling and AI are transforming cell culture media development for biologics. Thermo Fisher Scientific experts explore how integrating biological, analytical, and process data can guide formulation optimization, focus experimental efforts, and accelerate development. Learn how computational modeling and scientific expertise work together to support more informed, efficient, and data-driven media development decisions. Click here to learn more.

FOCUS ON REGULATORY

How To Strengthen Stability Studies For Market And Stronger Compliance

Safeguarding drug quality requires robust stability testing, yet legacy systems often hinder compliance. See how modern digital workflows eliminate manual errors and streamline study management.

Never Miss A Deadline: Why Scheduling Inspector Qualifications Is Imperative

Missing a qualification deadline compromises compliance. Uncover how centralizing training records and automated scheduling shifts your quality program from a reactive scramble to audit readiness.

5 Costly Consequences Of FDA Non-Compliance

Gain insight into how automated maintenance systems help pharma manufacturers avoid FDA citations, preserve client relationships, and build the documented reliability that wins competitive contracts.

Advancing Safety And Improving R&D Productivity With The Liver-Chip S1

Delve into how an innovative Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

Annex 1 Compliance Made Simple - Why Flow Rate Matters

Read about how biofluorescent technology with particle concentration capability consolidates viable monitoring, total particle counting, and sample collection into a single Annex 1-compliant platform.

REGULATORY SOLUTIONS

A System For Annex 1 Data, Reporting, And Interpretation Requirements - Particle Measuring Systems

Path To IND For Biologics Delivers Phase 1 Material In As Few As 9 Months - Thermo Fisher Scientific

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