bio-formulation-995x60
FEATURED ARTICLES
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![GettyImages-1418152314]( "Unpacking The Importance Of Lipid Nanoparticle Production Platforms")
Unpacking The Importance Of Lipid Nanoparticle Production PlatformsBatch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
WHITE PAPERS & CASE STUDIES
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Advancing A LNP Formulation To Clinical And Commercial Manufacturing")
Advancing A LNP Formulation To Clinical And Commercial ManufacturingLipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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![iStock-1213444268-vaccine-virus-syringe]( "PEG In LNP Formulations: Addressing Challenges And Seeking Solutions")
PEG In LNP Formulations: Addressing Challenges And Seeking SolutionsPolyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks. Explore those concerns, here.
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![GettyImages-1305685152 vaccine]( "The Heroes Of Vaccine Development: Lipid Nanoparticles")
The Heroes Of Vaccine Development: Lipid NanoparticlesLipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.
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![Lipid Nanoparticles GettyImages-1437855772]( "How To Make The Best LNPs")
How To Make The Best LNPsThere are various factors that require careful consideration throughout the process of formulating LNPs and utilizing them for successful mRNA delivery and translation.
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![GettyImages-1438509986-isolated-rna-lipid-nanoparticle-LNP]( "Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development")
Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug DevelopmentLearn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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![GettyImages-950086574 drug development]( "Recommendations For Successful IND Approval Of RNA-LNP Drugs")
Recommendations For Successful IND Approval Of RNA-LNP DrugsThe existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
PRODUCTS & SERVICES
Ideal tool for characterizing nanoparticles
The Corning Videodrop utilizes the principles of interferometry in conjunction with microscopy to sense, detect, characterize, and track single nanoparticles in real time. The operation of this bioproduction analytical device is seamless thanks to its intuitive software interface and efficient sample handling protocol.
Helix Biotech’s Nova™ Benchtop (BT) system is designed for lipid nanoparticle R&D and pre-clinical development – screen and optimize nanoparticle formulations quickly and with a versatile and scalable platform.
The NanoAssemblr® commercial formulation system is an automated, single-use system for the clinical and commercial production of lipid nanoparticles (LNPs) under cGMP conditions. Designed for efficient changeover and robust manufacturing processes, the system enables operational flexibility and standardized manufacturing of genomic medicines.
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Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products.
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.