
FEATURED ARTICLES
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Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies
Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.
WHITE PAPERS & CASE STUDIES
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Designing Protocols For A 40% Emulsifiable Concentrate Of A Systemic Insecticide
Explore 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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CQA Assessment Of LNP-Encapsulated IVT mRNA
Learn 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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Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines
Discover 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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Formulation Through Manufacturing Under One Roof
Partner 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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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review 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.
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Transferring From Microfluidics To A Turbulent Mixer
What solutions did the client featured in this case study find when they sought help in transferring their formulation process to a turbulent Impinged Jet Mixing (IJM)?
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.