bio-formulation-995x60
FEATURED ARTICLES
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![GettyImages-1403976499 vaccine, development]( "Accelerating Gene Therapy Development For NEDAMSS")
Accelerating Gene Therapy Development For NEDAMSSDiscover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.
WHITE PAPERS & CASE STUDIES
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![GettyImages-2178829362 GLP-1]( "Structural Characterization Of GLP-1 Analogues And Formulations Using MMS")
Structural Characterization Of GLP-1 Analogues And Formulations Using MMSDiscover how MMS quantifies peptide concentrations and identifies structural differences in GLP-1 and its commercial analogues across various buffer systems.
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![Formulation Development]( "Designing Protocols For A 40% Emulsifiable Concentrate Of A Systemic Insecticide")
Designing Protocols For A 40% Emulsifiable Concentrate Of A Systemic InsecticideExplore how formulation expertise can help overcome the complex challenges of developing stable, effective, and regulatory-compliant emulsifiable concentrate (EC) formulations for crop protection.
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![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "CQA Assessment Of LNP-Encapsulated IVT mRNA")
CQA Assessment Of LNP-Encapsulated IVT mRNALearn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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![GettyImages-1914829121-rna-strands-molecule]( "Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines")
Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP VaccinesDiscover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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![Pharma Manufacturing GettyImages-1135140594]( "Formulation Through Manufacturing Under One Roof")
Formulation Through Manufacturing Under One RoofPartner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Regulatory Considerations For Excipients Used In Lipid Nanoparticles")
Regulatory Considerations For Excipients Used In Lipid NanoparticlesReview the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
PRODUCTS & SERVICES
Immersion corrosion testing is a method used to determine the rate of corrosion of a test article, often a metal, in aqueous solution. Though this test can be used as an assessment tool for many applications, it is commonly used to evaluate the corrosivity of liquids.
Accelerate your drug development with our comprehensive pre-formulation, formulation, and novel delivery system expertise, tailored to optimize physical form, enhance solubility, and support scale-up.
Research Use Only (RUO) lipid nanoparticle (LNP) reagents to deliver RNA into hematopoietic stem cells (HSCs) for cell and gene therapy applications.
Off-the-shelf, research use only lipid nanoparticle (LNP) reagents to deliver RNA into T-cells.
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.
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.