Rapid Process Improvement Achieved By Applying A Rational Approach To Culture Media Optimization
The challenge of effective cell culture process development often involves how to simultaneously meet two competing needs: the need to maximize improvement of process performance and the need to minimize time spent on process development. By Tom Fletcher, Scott D Storms, and Jenny Y Bang, Irvine Scientific
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An Environmental Life Cycle Assessment Comparison Of Single-Use And Conventional Bioprocessing Technology
Biopharmaceutical development and manufacturing demand scalable processes that can be smoothly transferred to production. These processes need to be quickly developed and easy to implement.
Are You Into Biosimilars?
Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.
Supporting Advances In MAb Process Development And Manufacturing
GE Healthcare is a $17 billion unit of the General Electric Company (NYSE:GE), employing more than 46 000 people worldwide.
Streamlining The Biological Factory: Making A Better CHO Cell For Biopharma Production
SAFC’s CHOZN® Platform has been developed as a ‘plug and play’ manufacturing system for the creation of biopharmaceutical producing cell lines.
Save Up To 8 Hours In Cell Line Development With ZFN Technology
Zinc finger nucleases (ZFNs) have proven to be a powerful tool for modifying genes. In comparison to traditional techniques, such as adding chemical or radiation based mutagens that cause various random mutations, ZFNs can create very accurate, targeted changes to the genome in a much more rapid fashion.
Improved Productivity In Peptide Purification
Peptide therapeutics have been recognized as delivering the best of both worlds in terms of small molecule synthesis efficiency and biologics efficacy and reduced toxicity. However, challenges in mass production and low oral availability have historically made them less than ideal drug candidates. By Dr. Reno Nguyen, Scott Anderson, Dr. Chitra Sundararajan, Dennis McCreary and Dr. Jochen Saar
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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.