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FEATURED ARTICLES
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Addressing The Particulate Challenge In Cell Therapy Products
Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.
WHITE PAPERS & CASE STUDIES
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Control pH Adjustment And Reduce Complexity
Learn how automated, banded pH control uses dose-and-wait logic to limit overshoot, account for mixing and buffer effects, and maintain stable setpoints across changing fill volumes.
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Removing Bacteria In Biopharmaceutical Formulation And Filling Systems
A multi-stage filtration approach reduces microbial load, protects critical filters, and helps ensure consistent product quality, process reliability, and patient safety in biopharmaceutical manufacturing.
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Reducing The Bioburden Load In Drug Formulation And Filling
Sterile drug manufacturing requires preventing and removing contamination. Multi-stage filtration cuts microbial load, protects final filters, and supports quality, efficiency, and patient safety.
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Clarification & Prefiltration In Biopharm Formulation And Filling
Improve biopharma workflows with clarification and prefiltration that cut particulates and bioburden, protect downstream steps, and maintain protein product integrity.
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iPSC Aggregate Culture In Bioreactors Equipped With 8-Blade Impellers
Controlled aggregation, oxygen management, and scalable workflows drive consistent iPSC expansion. Parallelized systems and precise parameter control improve reproducibility for faster optimization and confident transitions.
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Monitoring Of A pH Optimization Approach For CHO Cell Cultivation
Cloud-based monitoring and analytics help centralize data, gain real-time insight, and improve decision-making. Enhanced visibility and collaboration enable faster optimization and consistency across development and manufacturing.
ABOUT
Formulation
Formulation in bioresearch is directly associated with pharmaceutical research and development. It is the practice of combining different chemical substances that include the active medical drug. This combination of drug and chemicals is tweaked until they have a final medicinal formulation that can be tested and receive final approval for large-scale market use.
The object of pre-formulation and formulation is to develop a stable preparation of a specific drug that is acceptable for human consumption. All drugs, by necessity, contain other chemicals. In order to put a drug into a capsule or tablet form it requires a variety of substances other than the drug itself. Formulation is needed to ensure that the drug will work when combined with these other substances.
It may surprise you to know that most formulations are not complete until after Phase III clinical trials are in progress or completed. All the early trials test drug stability, and drug load, which is the ratio of active drug to the total content of the actual dose.
Formulation studies address a variety of issues includinggrain size, pH (acidic or alkaline), solubility, and polymorphism (the ability of a drug to exist in more than one form like liquid and capsule). Other items formulation addresses is taste, appearance, tablet hardness and tablet or capsule disintegration.
Another aspect of formulation is testing how humidity, temperature, oxidation, ultraviolet light or visible light affects the formulation. The formula must be stable and not degrade under all of the different environmental factors.
Formulation involves a lot of experimenting with different blends of materials and drugs, but is absolutely crucial for the development of effective, safe, stable, oral drugs, and topical ointments.