Newsletter | October 11, 2024

10.11.24 -- Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients

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INDUSTRY INSIGHTS

Accelerate Your R&D And QC With These 3 Key Analysis Methods

Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.

Annex 1 Compliance Guidelines For Biological Indicator Users

Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

Method Transfer – When, Why, How?

A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.

Common Challenges And Solutions Of Equipment Ownership And Use

There are many factors to consider when tasked with acquiring the equipment needed to run a pharma facility. Being aware of every upfront cost is a must when determining optimal equipment ownership.

Revolutionizing Pharmaceutical Quality Control

Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.

Cleaning Proteins, RNA, And DNA From Laboratory Equipment

Read about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.

The Value Of Agile Project Management In Pharma's Race To Market

As regulatory policies for drug development tighten and competition intensifies, manufacturers must adopt organizational strategies that enhance flexibility, enabling them to keep pace in today's market.

Embrace Molecule Complexity With Optimized Expression Technologies

Examine the needs of more complex candidates, through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

Solutions To Clinical, Commercial Challenges In Pharma Development

Explore solutions to common quality, market demand, supply, and international manufacturing challenges faced when bringing new therapeutics to market.

Intensifying Downstream Bioprocessing With Continuous Technologies

Watch to learn about intensified downstream bioprocessing in-depth and take the first step toward a more innovative and efficient future in bioprocessing.

Evolution Of Novel Polymers To Overcome Limits In Sustained Drug Delivery

Degradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes and polyester amides. Explore a brief history of the development of PEA polymers.

FEATURED EDITORIAL

Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients

In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document,
Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

SOLUTIONS

Annex 1-Compliant Ultra Cold Storage Package System Qualification

A Conceptual Overview Of A Family Of Chromatography Systems

Continuous Pharmaceutical Filtration And Drying Systems

Technology To Overcome Absorption Hurdles And Solubility Limitations

Curia Capacity Update July 2024: Small Molecule APl And HPAPI Development

European Center Of Excellence For Clinical Biologics

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