FAQs
Amaran Biotech specializes in the development and manufacturing of complex drugs. We offer process development and cGMP manufacturing services (CDMO services) for new drug products and supply high-purity key materials for vaccine adjuvants.
Amaran Biotech excels in transitioning new drug products from R&D to GMP manufacturing. With state-of-the-art facilities and production line designs, we minimize the technical challenges to process scale-up and shorten development timelines.
Amaran Biotech specializes in the development and manufacturing of complex drugs, including complex active pharmaceutical ingredients (APIs), complex formulations/dosage forms, and drug-device combination products. Amaran Biotech has been the manufacturing site of a vaccine antigen that was designed with polysaccharides conjugated to a carrier protein. We keep accumulating experiences handling innovative complex drug substances composed of proteins, carbohydrates, and nucleic acids as building blocks.
In formulation development, Amaran Biotech has established a strategic partnership with Nippon Fine Chemical to provide advanced Drug Delivery System (DDS) solutions, with a focus on the design and development of liposomes and lipid nanoparticles (LNPs).
For sterile filling, Amaran Biotech has deployed a fully automated gloveless robotic isolator system, enabling filling operations for vials, pre-filled syringes (PFS), and cartridges. The system features minimal filling loss (below 50 mL) and a low incidence of quality events, significantly reducing development risks. It is suitable for filling high-value products, including proteins, antibodies, oligonucleotides, liposomes, lipid nanoparticles (LNPs), viral vector vaccines, cellular therapy products, and small molecule suspensions.
Amaran Biotech delivers high-purity key material AB-801/QS-21, a saponin-based vaccine adjuvant extracted from Quillaja Saponaria. QS-21 enhances immune responses by stimulating both antibody and T-cell immunity and promoting Th1/Th2 balance.
Vaccines are critical tools in addressing global public health crises. As key components of vaccines, the quality and supply stability of adjuvants directly impact vaccine efficacy and coverage. Amaran Biotech has overcome technical challenges in adjuvant purification to deliver high-purity adjuvant substances. By integrating multiple raw material supply chains, we ensure a reliable supply to meet the demands of large-scale commercial vaccine production.