bio-formulation-995x60
FEATURED ARTICLES
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![fundamental comparison metaphor or analogy-GettyImages-2191773530]( "Comparing Advanced Modality Needs, Part 1: Manufacturing")
Comparing Advanced Modality Needs, Part 1: ManufacturingADCs, AOCs, ATMPs, cell and gene therapies, and oligonucleotide therapeutics represent distinct but interconnected approaches to precision medicine. Let's take a closer look at their manufacturing needs.
WHITE PAPERS & CASE STUDIES
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![bioprocess-facility-GettyImages-2286540867]( "Single-use Mixing Systems For Protein Products: Dissolution And Mechanical Stress")
Single-use Mixing Systems For Protein Products: Dissolution And Mechanical StressMixer design and fill volume shape both how well a solution homogenizes and how much mechanical stress a protein experiences. Impeller configurations are compared against a conventional stirrer.
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![GettyImages-2280187429-lab-with-mixing-equipment-and-scientists]( "Improving Formulation And Aliquoting Efficiency With Mixing Solutions")
Improving Formulation And Aliquoting Efficiency With Mixing SolutionsSeparate formulation, filtration and aliquoting add transfers and integrity tests. A single closed flowpath can improve time, yield and contamination control.
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![cellular protein synthesis. mRNA vaccine research-GettyImages-2249044433]( "Optimizing GMP Manufacturing Of Lipid Nanoparticles For mRNA Encapsulation")
Optimizing GMP Manufacturing Of Lipid Nanoparticles For mRNA EncapsulationMoving mRNA lipid nanoparticle encapsulation from pre-clinical work to cGMP production is often underestimated. Early process parameter definition, raw material control, and scalable mixing determine how low-risk that transition becomes.
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![GettyImages-1298781737 aseptic filling]( "An Automated Cell-Processing Platform For MSC Harvest")
An Automated Cell-Processing Platform For MSC HarvestDiscover closed, automated harvest, formulation, and dispensing of umbilical cord MSCs at commercial scale, with data on viability, recovery, and filling precision, including single runs.
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![GettyImages-1389723406 protein]( "How EPR Unlocks Missing Dynamics In Pharma And Structural Biology Workflow")
How EPR Unlocks Missing Dynamics In Pharma And Structural Biology WorkflowUncover how EPR spectroscopy fills the conformational gap by capturing dynamic protein motions, refining Cryo-EM models, and revealing hidden structural ensembles for drug discovery.
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![GettyImages-1437855768-lipid-nanoparticle-lnp-mrna vaccine]( "High-Performing Ionizable Lipids For Controlled Nucleic Acid Delivery")
High-Performing Ionizable Lipids For Controlled Nucleic Acid DeliveryIonizable lipids are central to effective mRNA delivery, influencing potency, biodistribution, and toxicity. See why advancing delivery beyond the liver will require stronger structure-function insights.
PRODUCTS & SERVICES
The NanoAssemblr™ Ignite and Ignite+ systems provide an easy-to-use, scalable platform for reproducible lipid nanoparticle formulation. Choose the workflow and cartridge-use approach that fits your program today, with a validated path to clinical and commercial manufacturing when you are ready.
Developing mRNA treatments requires expertise in process development and LNP encapsulation for small biotech companies.
Enable a reliable, swift scale-up to cGMP manufacturing for mRNA encapsulation with the high-end FDmiX technology. Discover how to master challenges, streamline production, and enable faster, more predictable development of nucleic acid delivery systems.
Our custom expression platform directly addresses the primary host limitations in early-to-mid stage assay development:
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.
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.