bio-formulation-995x60
FEATURED ARTICLES
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![Bubbles-GettyImages-1028675986]( "Risk Managing Through The Void Of ATMP Visible Particle Guidance")
Risk Managing Through The Void Of ATMP Visible Particle GuidanceRegulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.
WHITE PAPERS & CASE STUDIES
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![GettyImages-2280187429-lab-with-mixing-equipment-and-scientists]( "Optimizing Liquid And Solid Mixing Across Variable Process Volumes")
Optimizing Liquid And Solid Mixing Across Variable Process VolumesDiscover how working volume, material type, and solids behavior affect single-use mixing performance, with practical findings on blend times, homogeneity, analytical methods, and agitation rates.
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![GettyImages-516466595-mixing-equipment-pharmaceutical]( "Evaluating Mixing Performance Across Liquids, Solids, And Powders")
Evaluating Mixing Performance Across Liquids, Solids, And PowdersAnalytical readings may indicate uniformity before mixing appears visually complete. Explore how material behavior, agitation, working volume, and addition methods affect mixing times.
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![GettyImages-1405217666-mixing-vessel-in-pharmaceutical-lab-scientist]( "Reliable Mixing Across Changing Batch Volumes")
Reliable Mixing Across Changing Batch VolumesSee how working volume and agitation speed influence mixing, with practical performance data to help teams assess efficiency across a broad range of upstream and downstream operating conditions.
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![GettyImages-512752430-lyophilization]( "Lyophilization Process Development For Antibody Drug Conjugates")
Lyophilization Process Development For Antibody Drug ConjugatesSee how scientific process development and QbD principles improve freeze-drying performance, strengthen product stability, and support biologics scale-up.
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![cell engineering, cell programming-GettyImages-1429299555]( "Evaluating Clone Performance And Cell-Specific Productivity")
Evaluating Clone Performance And Cell-Specific ProductivitySee how continuous process monitoring and automated at-line analytics support confident CHO clone ranking, consistent cultivation, and scale-up by connecting pH, viable cell density, and more.
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![GettyImages-2187764040-cell-culture-testing-manufacturing-in-lab]( "A Comparison To Traditional Clone Screening Platforms")
A Comparison To Traditional Clone Screening PlatformsSee how 46 CHO clones performed across automated, deep-well, and microbioreactor fed-batch cultures, using cell density, viability, and IgG concentration to evaluate clone performance.
PRODUCTS & SERVICES
Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.
The LevMixer™ 10 L single-use mixing system is a low volume mixer designed for both upstream and downstream applications.
DIANT Pharma provides continuous manufacturing systems and technical services for nanoparticle-based formulations. The company’s platform supports both research and manufacturing teams working on lipid nanoparticles (LNPs), liposomes, polymeric micelles, nucleic acid–lipid complexes, and other colloidal systems.
Simple, scalable genome engineering at the naturally occurring S-SELeCT™ safe harbor locus.
Build cell-based models of disease and accelerate therapeutic development with TARGATT™ large knock-in technology in iPSCs.
Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.
Developing nanoparticle formulations requires a scalable solution that replicates manufacturing conditions at a small scale. Turbulent jet mixing enables linear scalability while conserving materials.
Enabling you to design vaccines without reliance on animal sources with our fermentation-produced squalene.
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.