FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
Telltale Signs You’re With The Wrong CDMO
Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.
How To Pick The Right CDMO For Late-Phase Clinical Trials
For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.
What You Need To Know About Process Characterization And Validation For Biologic Processes
Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.
The Path To High-Quality Immunoassay Reagents
There is a continued demand for novel, fit-for-purpose immunoassays. Despite the challenges, it’s important for assay developers to streamline the selection and potential modification of critical reagents to get their tests to market quicker.
Enhanced Host Cell Protein Analysis In Biologics Manufacturing
iEnzyme-Linked Immunosorbent Assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates an enhanced anti-host cell protein antibody coverage analysis method solution.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions
This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).
Scale-Up Of CHO Cell Fed-Batch Cultures In HyClone ActiPro Medium Supplemented With Cell Boost 7a And 7b
This note compares cell growth and recombinant protein production of multiple Chinese hamster ovary cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.
Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures
This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.
Optimizing Cell Culture Media To Increase Cell Culture Titer With Maintained Protein Quality
When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiments (DoE) and empirical approach. Here is an example of how to do it.
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.