Newsletter | August 13, 2024

08.13.24 -- Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD

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INDUSTRY INSIGHTS

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

Optimizing Plasmid Production Strategies And Partnerships

To find the plasmid manufacturer with the appropriate knowledge and experience to manufacture your plasmid with quality and efficiency, you’ll need to recognize the offerings of a seasoned supplier.

Navigating The Fast-Expanding Medical Device Market In China

Review the evolving regulations for entering China's medical device market, and learn how collaborating with experts can help position your company to capitalize on this dynamic market.

Cold Chain Logistics And Packaging Considerations For Probiotics

Choosing the right packaging partner for your probiotic may be the most crucial step to ensuring your product is safe and potent when it reaches the consumer.

The Digital Transformation Of A Leading CDMO's Process Development Lab

Discover how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

A Lean, Agile Business Model To Deliver High-Quality Oncologic Treatments

No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.

A New Era Of Intuitive Simplicity In HPLC

Explore a collection of use cases demonstrating the performance of an intuitively simple HPLC system, including common pharmaceutical QC applications, method migration from legacy systems, and more.

Optimizing CMO Partnerships

SMC experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

Process Intensification And Connected Processing For mAb Manufacturing

Here, a proof of concept is presented, demonstrating how a batch process for mAb purification can be transformed into an intensified process and then a connected process in a strategic, stepwise manner.

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Delve into the complexities of scaling decisions to gain insights from biopharma developers and a CDMO. Explore valuable strategies for avoiding common pitfalls and more.

Benefits Of Automated Product Quality Management Software

What are the benefits of using automated product data management and quality management system software solutions in manufacturing?

FEATURED EDITORIAL

Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits And MVD

The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

SOLUTIONS

Annex 1-Compliant Ultra Cold Storage Package System Qualification

Quality, Compliance, And Regulatory Services For Life Sciences

Premier European Product Launch And Packaging Solution

Biodegradable Polyester Amide Platform

An Exclusive Tour Of A Mobile cGMP Cleanroom

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