Newsletter | September 14, 2020

09.14.20 -- Quality Data For FDA Submissions With Dr. Robert Hariri, Celularity

 
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What You Need To Know To Avoid Costly Delays In Your API Scale-Up

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

Is Not Using A CDMO Slowing Down Your Process Development?

Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

A Holistic Approach To The Prevention Of Mycoplasma Contamination

Any contamination of a biopharmaceutical production process is to be avoided for obvious quality, safety, and economic reasons.

The Roadmap To Outsourcing Vial Fill/Finish

Outsourcing a fill/finish project can be a challenging journey without a formal guide to the “right” path. Several key milestones along the way determine your outcome. This article will guide you through them.

Key Factors For Successful Technology Transfer

Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. 

Choosing A Cell Line Development Provider

One of the biggest decisions a biological medicine developer makes is to move forward with manufacturing their product. It's one of the most costly and complex decisions you'll make.

Critical Factors Of Fill/Finish Manufacturing For Large Molecules

Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.

Don't Sacrifice Yield For Purity In Downstream Purifications

Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. But not all mixed-mode resins are created equal.

Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain

To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative, yet efficient, route for drug substance, drug product, and clinical trial packaging needs.

Automated Foam Control Using A Single-Use Foam Probe

Foaming can cause increased contamination risks through potential exhaust filter fouling, poor mass transfer, product/cell entrainment, increased shearing from bursting bubbles, and cell death. 

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