bio-formulation-995x60 bio-formulation-995x60

WHITE PAPERS & CASE STUDIES

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.