What is Liraglutide?
Liraglutide, a so-called glucagon like peptide-1 (GLP-1) receptor agonist, is used for the treatment of type 2 diabetes mellitus (T2D) and obesity. Marketed as Victoza® and Saxenda® by Novo Nordisk, the drug is a peptide analog of the human GLP-1, a hormone with many functions in the human body.
Liraglutide is a long-acting peptide analog of GLP-1, because of a better resistance to DDP-IV-mediated degradation due to the presence of a fatty acid side-chain, which enables an efficient weight loss and glycemic management. Compared to GLP-1 with a half-life of a few minutes, this once-daily peptide analog given by injection under the skin offers a half-life prolonged to 13 hours. For these effects, the drug was first approved by the FDA for the management of T2D in adults in 2010, then, in 2014, for the treatment of obesity in adults who have at least one weight-related condition, and in 2019, also for the treatment of children 10 years or older with T2D.
Liraglutide can be commercialized as a synthetic generic product after approval of an abbreviated new drug application (ANDA) or comparable applications with other regulatory authorities. The length and modifications make technical excellence and regulatory expertise a prerequisite for efficient filing and fast approval. High material quality and yield, robust processes including secure supply and innovative approaches at high-tech facilities will enable our customers to achieve their business goals.
ENSURING YOU A SMOOTH REGISTRATION PROCESS
Bachem has a long track record with successful registrations of purified synthetic peptide drugs of the glucagon family. Our regulatory intelligence keeps track of important changes in the legislation. This enables us to be the top innovator in the field of glucagon and glucagon-like synthetic peptide drugs. The offered services have been optimized to shorten timelines and reduce complexity.
scalability, innovation and automation
From small to large-scale production with high quality
Our high-tech Good Manufacturing Practice (GMP) facilities are based in Switzerland and the US. Depending on needs small-scale to multi-kg active pharmaceutical ingredients (APIs) with impurities below 0.5% can be delivered (identification and characterization of impurities above 0.10% using orthogonal analytical techniques).
Optimized, automated high-yield production
High yields at outstanding quality is the result of experience and continuously optimizing the processes. The high level of process automation allows for cost-efficient and large-scale API manufacturing resulting in excellent overall material purity (>99.5%). Innovative solutions like continuous chromatography uses the equipment and resources more efficiently and helps to achieve the commitment to sustainability and environment-friendly production. Our GMP sites in Switzerland and California comply with and surpass the most stringent regulations.
Robust processes and supply security
In-house building blocks for peptide synthesis as well as long-term cooperation with trusted suppliers ensures on-time production. Redundancy of multi-purpose equipment and facilities helps to mitigate risks in the supply chain, together with our stock of finished APIs and is the key for on-time product deliveries to our customers.
The success of an abbreviated new drug application depends largely on the impurity profile of the synthetic peptide drug compared to the impurity profile of the reference listed drug (RLD) and the level of achieved “sameness”. We identify impurities, characterizes peptide-related impurities that are above 0.10% of the drug substance or greater, and provides impurities as catalog products.
Related products (for research purposes only)
Beyond GMP-grade liraglutide, we provide liraglutide in research grade, variants thereof and in different salt forms.
Bachem also provides exenatide, semaglutide, glucagon and other APIs for diabetes management.
Bachem Regulatory Documentation
US GDUFA DMF anticipated to be available early in 2023
Fields of Application
Treatment of type II diabetes mellitus
Treatment of obesity
The peptide API Liraglutide acts in the same way as GLP-1, the hormone produced in the gut. It helps increase the amount of insulin released by the pancreas in response to consumed food. Liraglutide allows patients with type 2 diabetes to control their blood sugar levels better.
Relative Molecular Mass
-20 ± 5°C