Newsletter | August 12, 2025

08.12.25 -- Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices

INDUSTRY INSIGHTS

Proven Strategies For GxP Compliance And Inspection Readiness

Struggling with data integrity challenges? Discover proven strategies for GxP compliance and inspection readiness in this essential webinar. Learn to build a robust framework and avoid common pitfalls.

A Guide For Future-Proofing Your Operations In Life Sciences

Traditional MES is costly, rigid, and slow to adapt. Explore how a Composable MES for Pharma offers flexible, real-time solutions with reusable, configurable apps that streamline operations.

Optimizing Tablets For Even Splitting: The Pressure Sensitive Bisect Design

The pressure-sensitive bisect design allows accurate tablet splitting by maximizing facet width, optimizing angles, and balancing radius values for durability and user-friendly administration.

Strategic CMC Planning Through A Phase-Appropriate Quality Approach

A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to CMC planning.

Target Product Profiles And Phase 1 Clinical Plans

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

Balancing Biologic Limitations And Patient Perceptions

Examine an innovative sTW needle design reduces injection force and pain, enhancing comfort and ease for chronic patients while promoting long-term adherence through improved injection experiences.

Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids

Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.

The Power Of AI And Route Scouting To Navigate API Complexity

Using AI tools for retrosynthesis can help you investigate molecules interactively to build a complex API manufacturing process that maintains your timeline and saves you money.

Use Of Reconstructed Tissue And 3D Printed CT-Based Nasal Casts

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Building the right cleanroom involves critical early decisions. Read about a methodical framework that ensures flexibility, compliance, and operational readiness from initial concept through delivery.

Driving Continuous Improvement In The Digital Age

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

Reaching BLA Success: Fast-Track Approach To Process Characterization

Find out how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Digitalizing Batch Records In Pharmaceutical Production

Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

FEATURED EDITORIAL

Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

SOLUTIONS

Advancing Vaccines From Preclinical Development To Commercial Supply

Pharmaceutical Bottom Labeler

Enabling Boundless Automation In The Life Sciences Industry

Medical Writing Software

Sachet Packaging Solutions

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