About Bioanalytix
Bioanalytix: Revolutionizing the Biopharmaceutical Industry with Advanced LC-MS Analytics
Bioanalytix is a leading biotechnology company that specializes in advanced LC-MS based analytics and data analysis of complex biologics. The company works with some of the biggest names in the biotherapeutic industry, providing cutting-edge solutions for candidate selection, regulatory package development, and BLA.
With over a decade of experience in the field, Bioanalytix has established itself as a trusted partner for companies looking to develop innovative biologic drugs. The company's team of experts includes scientists, engineers, and analysts who are dedicated to delivering high-quality results that meet or exceed client expectations.
At Bioanalytix, we understand that developing new biologic drugs is a complex process that requires careful attention to detail at every stage. That's why we offer a comprehensive suite of services designed to support our clients throughout their drug development journey.
Our services include:
1. Candidate Selection: We use advanced LC-MS analytics to identify promising candidates for further development based on their physicochemical properties and biological activity.
2. Formulation Development: We work closely with our clients to develop optimized formulations that ensure stability and efficacy throughout the drug's lifecycle.
3. Process Development: Our team uses state-of-the-art analytical tools to optimize manufacturing processes and ensure consistent product quality.
4. Analytical Method Development: We develop robust analytical methods for characterizing complex biologics using LC-MS techniques such as intact mass analysis, peptide mapping, glycan profiling, and more.
5. Regulatory Support: Our experts provide guidance on regulatory requirements and help prepare regulatory packages for submission to global health authorities such as FDA/EMA/CFDA etc..
6. Quality Control Testing : We perform routine QC testing including identity testing (mass spectrometry), purity testing (HPLC), potency assays (bioassays) etc., ensuring product quality from batch-to-batch consistency
At Bioanalytix , we pride ourselves on our ability to deliver high-quality results quickly while maintaining strict adherence to industry standards such as GMP/GLP/GCP guidelines . Our state-of-the-art facility is equipped with cutting-edge instrumentation including multiple mass spectrometers coupled with UPLC/HPLC systems which enable us analyze samples faster than ever before without compromising accuracy or precision .
In conclusion , BioAnalytix is an innovative leader in advanced LC-MS based analytics offering comprehensive solutions across all stages of drug development from candidate selection through regulatory package development & BLA submission . With its experienced team of scientists & engineers combined with its state-of-the-art facility equipped with latest technology instruments , it provides unparalleled service quality & speed which makes it stand out among other competitors . If you're looking for reliable partner who can help you bring your next-generation biotherapeutics from bench-to-bedside then look no further than BioAnalytix!