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Biological & Fermentation Development

from Rondaxe
Martin Smith
December 17, 2021

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The Rondaxe development team has extensive expertise in many sections of the industry.
Apart from developing small molecule therapeutic substances, Rondaxe has significant
expertise in biology and cell culture technologies including cell line creation, recombinant
protein production, and biotransformation. Our drug product development team has
extensive expertise in formulating, scaling up, and commercializing sterile, oral solid,
ophthalmic, topical and veterinary medicines. Our analytical development team has
extensive expertise in developing and validating techniques.

Our Services

Report Documentation
Formulation Development
Regulatory Starting Material Definition
Excipients/Ingredient Selection
Analytical Testing/Validation
Synthetic Route Strategy Development
Analytical Strategy Development
Drug Product Analytical Methods Development
Biocatalysis Strategy Development
Feed and Media Optimization
Strain Selection
IPC & PAT Method Development
Synthetic Route Selection
Protein Fermentation & Purification
What are the Benefits?

Solutions for all areas of your development requirements

Access to our highly experienced industry team

Rondaxe specializes in chemicals, pharmaceutics, analytical development, route scouting,

scale-up, manufacturing, distribution and drug commercialization.

For more information on Bio & Fermentation Development, please visit rondaxe.com or call
(315) 469-2800.

Scale-up Considerations

Cooling

While dry ice may be used as a cooling agent in a laboratory to improve reaction selectivity,
the procedure becomes more complex on an industrial scale. The expense of cooling a
conventional reactor to this temperature is high, and the viscosity of the reagents usually
rises as the temperature decreases (making mixing more difficult). This increases the
expense of stirring harder and replacing components more often, resulting in a non-
homogeneous reaction. Finally, lower temperatures may cause crusting of reagents,
intermediates, and byproducts to the reaction vessel over time, reducing product purity.

Stoichiometry

Various reagent stoichiometric ratios may result in different product ratios. Adding a
significant quantity of reagent A to reagent B on an industrial scale may take some time.
During this time, the added reagent A is exposed to a considerably larger stoichiometric
quantity of reagent B until it is completely added. This imbalance may cause reagent A to
react prematurely and subsequent products to react with the massive excess of reagent B.

Rondaxe Provides Consulting Rondaxe offers Bio & Rondaxe provides Bio &
on Bio & Fermentation Fermentation Development. Fermentation Development
Development November 2, 2021 services
November 2, 2021 In "Research" October 17, 2021
In "Research" In "Research"

A must-have for breakfast

It can be used in all kinds of cooking/drinks/desserts and it’s environmentally
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Plant-Based Crew

TAGS: Biological & Fermentation Rondaxe Pharmaceutical

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