Empowering API Quality Enhancement! Medicilon Received the 'Best Collaboration Award' from Jingye Medicine & Chemical Co., Ltd

On the journey of drug development, each collaboration is a profound test of professional competence and a severe test of professionalism. Recently, Medicilon USA Corp. (Medicilon) is honored to have received a thank-you letter from Jingye Medicine & Chemical Co., Ltd (Jingye Medicine) and was awarded the "Best Collaboration Award". This not only recognizes the professional capabilities and service level of Medicilon, but also reflects the result of the joint efforts and tacit collaboration between the two parties.

Best Collaboration Award.webp

Medicilon and Jingye Medicine
Work together to overcome difficulties and achieve fruitful collaboration

Jingye Medicine, as a secondary safety production standardization enterprise for hazardous chemicals, continues to demonstrate outstanding professional capabilities and profound industry accumulation in the fields of pharmaceutical raw materials, pharmaceutical intermediates and CDMO project services. In collaboration with Jingye Medicine, the Medicilon team has always upheld professionalism, closely collaborating with Jingye Medicine's process and analysis teams to jointly face and successfully overcome a series of technical challenges in the research and development process, ultimately ensuring the smooth progress of the project.

Currently, Medicilon has been involved in five projects with Jingye Medicine, with three of them are under development. These successful collaboration cases not only demonstrate the outstanding capabilities of both parties in the pharmaceutical research and development field, but also establish a solid foundation for future in-depth collaboration between the two parties.

Medicilon one-stop API CDMO service platform

In the field of APIs, Medicilon currently possesses cGMP-compliant production lines for APIs that meet the requirements for IND filing in both the United States and China. From preclinical small-scale synthesis and process development to commercial production, Medicilon integrates deeply with the entire supply chain system of enterprises, including research and development, procurement, and production. The production scales could be flexibly adjusted ranging from milligrams to kilograms. Meanwhile, Medicilon possesses a rigorous and experienced analysis and quality inspection team, providing precise analysis services and strict quality control throughout the project.

The Medicilon's Process Department not only provides clients with services in the R&D, analysis testing, and stability research of generic drugs, but also offers services for the R&D, production, analysis testing, and stability research of innovative drugs in Phase I and Phase II clinical trials, gradually transitioning from R&D process development to industrial commercial production, and from CRO to CDMO.

About Jingye Medicine

Jingye Medicine & Chemical Co., Ltd. was established in 1998 in the Suzhou High-tech Zone Incubator, mainly producing APIs, pharmaceutical intermediates, and CDMO project services. The company covers an area of nearly 80 acres, currently employing 282 people, and owns 9 commercial production workshops, including 3 GMP workshops and 1 CDMO workshop. The main products include intermediates for Pemetrexed, Quetiapine Hydrochloride, Quetiapine Fumarate, Paroxetine Hydrochloride, and Sitagliptin intermediates. In 2008, the company passed the ISO9001 Quality Management System Certification, ISO14001 Environmental Management System Certification, and ISO18001 Occupational Health and Safety Management System Certification. In 2014, it obtained the Jiangsu Province Safety Standardization Level II Certification. In 2021, it obtained the Drug Production License. So far, the company has 36 high-tech products, applied for 25 invention patents, and obtained 15 authorized patents. In 2023, Jingye Medicine achieved a production value of RMB 230 million.

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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