Our CMC services for large molecules include a comprehensive range of general and compendial testing such as:
Our expertise in CMC ensures that your large molecule product meets regulatory requirements and is of the highest quality.
Our large molecule CMC services include comprehensive impurities testing, utilizing advanced techniques such as:
Trust us to ensure the purity and safety of your large molecule drug product.
Our large molecule CMC potency of your product. By leveraging our expertise in these techniques, we can provide accurate and reliable measurements of your product’s biological activity, helping you to better understand its efficacy and safety.
We offer ICH-compliant stability studies as part of our large molecule CMC services. Our stability studies are designed to provide you with a clear understanding of the stability profile of your large molecule and to help you make informed decisions about its development and commercialization. We utilize a range of testing protocols and conditions to ensure that your product remains stable under a variety of conditions and over time, giving you the confidence you need to move your product forward.
Our structural analysis service for large molecule CMC utilizes cutting-edge mass spectrometry techniques to provide comprehensive characterization of your biologic drug. We offer:
We ensure the structural integrity and purity of your product. Our experienced team follows ICH guidelines to provde reliable and accurate result to support your drug development process.
We offer comprehensive higher order structural analysis for large molecule CMC using cutting-edge techniques such as:
Our services provide detailed insights into the three-dimensional structure of your large molecule, allowing you to optimize its stability, efficacy, and safety
We offer N-glycan profiling as part of our glycosylation analysis services for large molecule CMC. Our advanced technology allows us to provide a comprehensive understanding of glycosylation, including identification and quanititation of N-glycans, glycan profiling, and characterization of glycans. With our cutting-edge tools and expertise, we can help you optimize glycosylation to ensure safety, efficacy, and compliance of your biologic product.
Our small molecule CMC services cover three key categories:
Our analytical services are designed to help you achieve your goals of bringing safe and effective small molecule drugs to market. We provide a range of services.
Our team is equipped with the latest technologies to perform a wide range of tests such as HPLC, dissolution, GC, FTIR, UV, potentiometric titration, KF, wet chemistry, particle size, and more.
We have years of experience in developing and validating analytical methods.
Our team can perform a range of tests to ensure the quality of your small molecule drugs, including purity, potency, and identity testing.
We can help you ensure that your manufacturing equipment is properly cleaned and validated to avoid cross-contamination and ensure product quality.
Our stability management and testing services include:
We provide comprehensive stability testing services that help ensure your product’s safety, efficacy, and quality throughout its shelf life. Our state of the art facilities and experienced team allow us to offer a range of storage conditions and testing options, including accelerated and long-term stability studies, as well as photostability and in-use stability testing.
With our stability management services, you can be confident that your product is being stored and monitored appropriately, and that you will receive reliable data to support your product’s registration and commercialization.
We perform dissolution testing using various media, including simulated gastric and intestinal fluid, to determine the release profile of the drug substance from the dosage form. We also conduct dose dumping testing to evaluate the risk of drug release in large quantities due to various external factors, such as changes in pH, temperature, or agitation.
We conduct disintegration testing to determine how long it takes for the dosage form to break down into smaller particles, which is important for drug delivery and bioavailability.
We perform solubility testing to asses the drug substance’s solubility in different media, including aqueous and organic solvents and various pH conditions. This information is critical in determining the most appropriate formulation strategy for the drug substance.
We perform compatibility testing to ensure that the drug substance and excipients are compatible and stable when combined in a formulation. This testing is important to avoid potential degradation or instability of the formulation over time.
We perform impurity profiling to identify and quantify impurities present in the drug substance or drug product. This information is critical in determining the purity of the drug and evaluating its safety and efficacy.
We perform forced degradation studies to evaluate the drug substance’s stability under various conditions, including exposure to heat, light, and acidic or basic conditions. This testing is essential for identifying potential degradation pathways and impurities that may be formed during the shelf life of the drug product.
We perform residual solvent testing to identify and quantify any solvents remaining in the drug substance or drug product after the manufacturing process. This testing is important for ensuring the safety of the drug product and compliance with regulatory requriements.
New Jersey
259 Prospect Plains Rd
Cranbury, NJ, 08512
732.783.7398
bd@accurantbiotech.com
Shanghai
Room 505, Floor 5
No. 8, Jiafeng Rd.
Free Trade Zone
Shanghai, China
Ningbo
Floor 4, Building A5
No. 587, Juxian Rd.
High-Tech Zone
Ningbo, China
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