Amaran Biotech provides a range of drug development services from process development & optimization, supply chain management, to clinical and commercial cGMP production with a comprehensive range of analytical and regulatory support.
Transitioning a new drug candidate out of the laboratory into and through clinical studies to full commercialization is a timely process. Success and value can hinge on how quickly a drug candidate can obtain regulatory approval and be brought to market. Amaran Biotech partners with its clients to advance their innovative product pipelines in a focused and collaborative manner. Through proactive project management, our team of experts will help expedite your drug development & manufacturing process to bring it to a commercial level.
Amaran Biotech’s technical teams have the expertise and knowledge in standards appropriate to manufacturing complex high value drug substances, we have solid track record with immunotherapy products. Currently, Amaran Biotech’s unique manufacturing capabilities include ozonolysis, thiolation, diafiltration by tangential flow filtration, carbohydrate-protein conjugation, protein and natural product purification and drug substance lyophilization.
In our modern state-of-the-art manufacturing facility, we have established a cGMP quality system in compliance with global pharmaceutical guidelines (i.e., ICH, USP and EP) and regulatory requirements (i.e., US FDA, TFDA and EMA). Amaran Biotech also offers full analytical and quality control support which includes analytical method development, method validation and sample stability testing.
We currently offer the following three storage conditions for stability samples:
- 25°C RH60%
- -20°C ± 5°C
Amaran Biotech’s future expansion plans include dedicated carbohydrate-synthesis suites and installation of modular drug product manufacturing systems. Our goal is to deliver quality product and customized service, while providing flexibility and guidance to help our clients achieve their goals in a timely and efficient manner.
Contact Us for more information about our services and how we can help bring your product to market.