Newsletter | September 5, 2024

09.05.24 -- Should You Be Using Unique Container Identification?

SPONSOR

Webinar: Cleanroom Conceptual Design Paradigm: Converting Spaces for GMP Operations

This webinar on September 26, 2024, at 11:00am EDT, will explore designing life sciences cleanroom spaces that allow for the development of the science and the capability to host commercial scale GMP manufacturing. Learn more about an integrated design process that gives confidence for regulatory alignment, optimal design functionality, and environmental performance.

INDUSTRY INSIGHTS

Round Tablet Compression Tooling — To Key Or Not To Key The Punches

What makes the keying in tablet compression tooling, specifically in tablet punches, so important to the tablet manufacturing processes?

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

Learn how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.

Measuring Filter Performance—It's More Than Just A Label

How is the performance of a filter measured? Learn why the micron rating is an incomplete measure of filter performance, why the beta ratio is a more accurate indicator, and much more.

Sustained, Controlled Drug Delivery To The Eye

Examine how a platform that leverages polymeric implantable drug delivery systems enables improved bioavailability, patient compliance, and mitigation of issues associated with repeated injections.

Data Collaboration Driving CDMO Excellence, Product Innovation

CMOs and CDMOs who do not address the rising demand from life science clients for greater visibility in the manufacturing process risk falling behind.

Re-Engineering A Complex Process For FDA Compliance

Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

FAT, SAT, IQ, OQ, SMEPAC - What Does It All Really Mean?

Gain insight into the proper timeline for process validation, the importance of linking the User Requirements Specification (URS) to each step of validation to ensure complete compliance, and more.

EMPQ And Validation Support Services

A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

Advancements In Aseptic Connection Technologies

Expand your knowledge of the latest innovation in the sterile connector space including the new 1.5” flow path connector, disconnection solution, and more.

PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

Achieving Speed And Scale With Optimized Synthesis Solutions

Realize optimal coupling efficiency and increase your productivity for oligonucleotide drugs by selecting the right synthesizer and prioritizing automation to define and tweak synthesis methods.

Preparing The PMS: A Commercial And Regulatory Imperative

Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry.

FEATURED EDITORIAL

Should You Be Using Unique Container Identification?

Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

SOLUTIONS

Industrial Data Operations Software Solution For Life Sciences

Container Closure Integrity Testing (CCIT) For Pharmaceutical Vials

Aggregation Solutions For Efficient Track And Trace Operations

Flexible Blister Packaging Equipment For Parenterals

New Solutions For Large Molecule Analysis

The Ultimate Guide To Clinical Supplies For Japan Studies

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