Newsletter | February 20, 2025

02.20.25 -- Top 10 Data Auditor Statistical Software Requests

INDUSTRY INSIGHTS

Optimizing CAPA For FDA Recall Success: A Roadmap For The Life Sciences

Uncover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

Control API Impurities To Achieve Therapeutic Safety For Patients

In your CDMO search, prioritize finding a partner who recognizes impurity control as a critical component of patient-focused drug development and offers the necessary capabilities to ensure safety and efficacy.

Data Integrity In The Quality Control Lab: No Pen, No Pain

Data integrity in pharmaceutical QC labs is critical for product safety. Explore digital solutions to improve traceability, reduce paperwork, and enhance workflows.

Insight From An Expert: A Chemist's Secrets To Efficient API Scale-Up

The more efficient your API synthesis, the lower your cost of goods. Gain insight into one expert's tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Four Reasons For The Rise In Blister Packaging

Discover the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

Cloud-Driven Transformation: Empowering Business Agility And Security

Find out how cloud solutions empower businesses to achieve agility and security in their digital transformation journey, and explore key considerations and insights from real-world success stories.

Empowering A New Era Of Patient-Centric Medicines

Delve into the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

Identify And Mitigate Absorption Risks With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

High Shear Mixer Considerations For The Cannabis Industry

The growing demand for cannabis-infused products provides an opportunity and a challenge for manufacturers. Gain insights into high shear mixers and how they can be used to create these products.

Increasing Delivery System Flexibility Through Solvent-Based Processing

Reveal how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug eluting carrier with a wide variety of APIs.

A Solvent-Free, Fusion-Based ASD Manufacturing Process

Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

The Scalability Of Depth Filters For CHO Cell Culture Clarification

Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of disposable depth filters, demonstrating their effectiveness.

Particle Counter Installation Considerations For Continuous Monitoring

When specifying particle counters for continuous monitoring applications, there are many system design decisions to be made. Read about the advantages of using a remote particle counter.

Fundamentals Of Particle Size Analysis

Uncover the importance of particle size characterization and the advanced analytical techniques employed to assess micronized particles effectively.

FEATURED EDITORIAL

Top 10 Data Auditor Statistical Software Requests

Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions. Learn how to ensure data integrity and reliability for the statistical analysis of GxP data.

SOLUTIONS

Pharmaceutical Isolator Glove Testing System (GTS) For Annex 1 Compliance

File First In Europe, Then The U.S.

A Leading Digital Validation Platform For Life Sciences

Pharmaceutical Digital Transformation And Harmonization Programs

A Combination X-Ray Inspection And Weight Control System

An All-In-One Rapid Contamination Control Service

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