API peptides play a critical role in pharmaceutical development, just like a leading API pharmaceutical company does, to bring innovations in drug development and manufacturing. Among various firms operating as CDMOs, Asymchem is outstanding in this area and possesses the highest level of competence in peptide development and manufacturing. Let’s discuss Asymchem’s position as an API pharmaceutical company, and how our innovative services make the pathway from development to market easier.
The Important Role of API Peptides in Pharmaceuticals
API peptides are an indispensable component in the pharmaceutical field, which actively participate in building up drugs involved in various therapeutic areas. Such peptides may be targeted against certain biological functions, and that is what makes them of such great value for the development of drugs against diseases like metabolic disorders and cancers.
Key Types of API Peptides:
Arginine-rich Peptides: Generally used in PDCs and natural peptide modifications.
Fragment Banking: Dipeptide, tripeptide, and tetrapeptide libraries are in high demand for research and development.
Unnatural Amino Acids: Special peptide syntheses and unusual starting materials. Peptide Excipients: Playing a critical role in stabilizing and enhancing the effectiveness of peptide drugs.
Asymchem – API Pharmaceutical Solution Provider
As a leading API pharmaceutical company, Asymchem leverages unparalleled expertise at each stage of the peptide lifecycle to provide comprehensive support from development to manufacturing for peptides.
Asymchem by the Numbers
220+ Seasoned Chemists: More than 220 process and analytical chemists comprise this group, with over 50% holding advanced degrees such as PhDs and master’s degrees.
45+ IND peptide projects: More than 45 IND peptide projects have been managed successfully.
10+ Phase II/III peptide projects: Over 10 peptide projects in advanced Phase II/III have been handled.
7 Global Production Sites: Our sites support peptide production globally, with the aim of ensuring quality and scalability.
14,000 L SPPS Capacity: Currently, it has a capacity for SPPS of 14,000 liters, which is under expansion to reach a capacity of 20,000 liters by December 2024.
20,000 L Fermentation Capacity: We have significant fermentation capacity for the manufacture of peptides in many different applications.
120+ m² Lyophilizer Capacity: Significant lyophilizer capacity to further preserve and stabilize peptide products.
Fully Integrated Peptide Capabilities at Asymchem
Asymchem provides a wide range of peptide services to meet any given requirement to the highest possible standards of quality and efficiency.
Our Peptide Capabilities Include:
GLP-1 API Peptides: For metabolic and diabetes-related research.
Cyclic, Linear, and Stapled Peptides: The range of variants meets various therapeutic needs and applications.
Full-Service Offering: Our process is designed to expedite time-to-market, from peptide development through GMP batch manufacturing to IND/NDA filing.
Average Timeline:
Peptide to IND: Deliver GMP batch within 3-6 months.
Peptide to NDA: Complete NDA filing package within 12-18 months.
Advanced Technologies for Peptide Synthesis
Our commitment to advanced technology means that we provide the most efficient solutions for peptide synthesis:
SPPS: Suited for polypeptides, with fast development times, cost-effectiveness, and low solvent consumption.
LPPS: Scalable into the hundreds of kilograms range, suitable for short peptides; low consumption of solvents and improved purity.
NCL & CEPS: This method has very low racemization and good solubility for polypeptides/small proteins.
Bio-synthesis: High-density fermentation cost-effectively produces long peptides.
Why Choose Asymchem?
Expertise and Innovation: Bringing the best results by leveraging advanced technologies coupled with a talented expert team.
Scalability: Scalable solutions that fit various needs in production.
Regulatory Compliance: Meeting regulatory requirements of different countries and marking successful entry into the markets.
Conclusion
Partnership with Asymchem as your API pharmaceutical company is a strategic advantage in view of peptide development and manufacturing. With our broad capability, advanced technology, and commitment to excellence, your peptides will be developed efficiently and effectively to set the pace for successful commercialization.
FAQs
What is an API peptide?
API is the peptide as an active pharmaceutical ingredient within a drug formulation that is designed to target a specific biological process that has therapeutic benefits.
How does Asymchem support peptide development?
It serves a wide array of services ranging from peptide synthesis, GMP batch production, regulatory support, and commercialization.
What is the key benefit of working with Asymchem?
Advanced technologies, scalability, regulatory compliance, and a comprehensive continuum of support throughout the lifecycle of the peptide.
What is the typical timeline for peptide development at Asymchem?
Generally speaking, peptide to IND takes 3-6 months, and peptide to NDA takes about 12-18 months, depending on the complexity of each project.
What are the advanced technologies utilized by Asymchem for the synthesis of peptides?
Asymchem focuses on SPPS, LPPS, NCL, and Bio-Synthesis for high efficiency and high quality in the manufacturing of peptides.