Newsletter | February 7, 2025

02.07.25 -- A Justification For Using In-Process Controls In Place Of Cleaning Validation

INDUSTRY INSIGHTS

Are Drugs Becoming More Lipophilic Over Time?

Get a deeper look into how drug lipophilicity has evolved over time, its impact on drug development, and the need for new technology to enable new, more complex drugs.

Accelerated Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

The Immediate Benefits Of Real-Time Microbial Monitoring

Airborne microbial contamination is a serious concern for companies producing medicines and biotech products, and it must be addressed to ensure that products and people are kept safe.

Essential Insights Into Pharmaceutical Product Release: Part 2

Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality.

Challenges Of New Molecular Format Development

Explore results from a survey conducted to confirm the challenges of new molecular formats, as well as identify any additional challenges in developing biologics based on them.

Sterility Testing: Isolator Solutions To Minimize Contamination Risk

Sterility testing is susceptible to contamination, resulting in costly false positives, batch failures, and production delays. Isolator technology offers a robust solution to mitigate these challenges.

A New Approach To First-Pass Yield

Learn how a life sciences manufacturer generated a contextualized data set that eliminated the manual effort required to curate production data and improved their process in real time.

Reducing The Environmental Footprint Of Oligonucleotides

Industry experts answer attendees' questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

Sustained-Release Implants: A Targeted Approach To Drug Delivery

Implantable drug delivery systems hold the potential to revolutionize cancer treatment by enhancing efficacy, reducing toxicity, and alleviating the burden of treatment for patients.

Detection Of Endotoxin And Non-Endotoxin Pyrogens By MAT

Experts explain what a pyrogen is as well as the differences between an endotoxin pyrogen and a non-endotoxin pyrogen. Learn why it is immensely important to detect non-endotoxin pyrogens.

Accelerating Clinical Development: Modern Tools In Process Chemistry

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

HPAPI Processing And Drying Suite For Operator And Product Protection

A two-part enclosure consisting of a single pass airflow glove box enclosure and a nitrogen purge enclosure was designed to provide protection to the operator and product.

FEATURED EDITORIAL

A Justification For Using In-Process Controls In Place Of Cleaning Validation

This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

SOLUTIONS

Cleanroom Technology For Unparalleled Cleanliness And Speed

Multi Shaft Mixers For Complex Formulations

Drug Product Fill And Finish Capabilities

Next-Generation Superior Cellulose Membrane

Solvent-Free, Fusion-Based Amorphic Dispersion Process

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