R&D and Manufacturing
研發與制造
Beijing Poly Biopharm Co.
Beijing Poly Biopharm is a R&D Institute for innovative drugs jointly established by the Institute of High Energy Physics (IHEP) of the Chinese Academy of Sciences and Hainan Poly Pharm Co., Ltd. (Poly Pharm), specialized in transformation in the fields of drug delivery systems, nanobiotechnology, nucleic acid and protein technology, microbiology, and small molecule compounds. It consists of 23 members in the R&D team, including 6 PhDs, 14 Masters, with a percentage of 87% holding postgraduate degrees or above. With the core advantage of boron neutron capture therapy and new targeted boron drugs by IHEP, the Institute focus on combination therapy for treating a series of tumors, and exploration of transformation in the drug fields of delivery systems, nanotechnology, protein nucleic acids, microorganisms, small molecule compounds etc.
Raw Materials Research Institute
It mainly focus on the research and development of the following aspects: (1) Specialty APIs, (2) Medical beauty and cosmetic intermediates, and (3) Targeted delivery excipients. With a strong talent reserve and technological accumulation, the Raw Material Research Institute has established several specialized technology platforms, such as a safety evaluation testing platform, crystal form research testing platform, purification technology platform (nano filtration, ultrafiltration, high-pressure and low-pressure industrial preparation HPLC systems), continuous flow technology platform, fixed bed hydrogenation platform, and special drying technology platform (freeze-drying, spray drying), etc. After several years of technological accumulation, Poly has more than 20 varieties that are ready for production in its Anqing manufacturing site, including APIs for gadolinium contrast agents, iodine contrast agents, anti-infection products, anti-tumor products, etc. In addition, cosmetics for skin whitening and moisturizing, excipients to increase drug solubility, and ionizable liposomes for mRNA drugs are also gradually being developed for production.
Bio-technology Research Institute
As a research and development platform centered around synthetic biology, we have established a full-chain R&D platform that covers gene modification to product commercialization. We have made significant progress in the construction of the synthetic biology platform and product pipelines, which include: (1) the synthetic biology manufacturing of important raw materials for health products, functional foods, and cosmetics. By using gene editing technologies such as CRISPR/Cas, we rationally reconstructed the product synthesis pathways in various industrial production chassis cells, such as E. coli, yeast, and glutamic acid bacteria, and optimized the target product's industrial development through metabolic pathway network regulation. (2) In the field of enzyme preparations, we have established a series of high-quality candidate enzyme libraries by combining rational design-directed evolution strategies assisted by computer AI and irrational high-throughput screening platforms. On the one hand, they are used as biocatalysts for the enzymatic catalytic process development of heavyweight raw materials, and on the other hand, they develop conventional enzyme preparations with huge application potential, forming a series of C-end products combined with the big health pipeline.
Pharmaceutical Preparation Institute
The product pipeline of the Institute covers two main areas: generic drugs (including sterile injections, freeze-dried powder injections, contrast agents, eye drops, solid preparations, semi solid preparations, inhalers, etc.) and improved new drugs. Currently, the company has obtained 68 domestic production licenses and 97 overseas production and marketing licenses for generic drugs. There are more than 70 products under review both domestically and internationally. After more than a decade of practice and experience, the RA team has established close communication channels with pharmaceutical regulatory agencies both domestically and internationally. Since the implementation of the generic drug reform in China in 2015, Poly has obtained 18 products passing the consistency evaluation, including 5 products listed as the first in approvals. The international market includes nearly 20 countries or regions on five continents. Among them, there are 17 products on the US market, and multiple varieties have been approved within the FDA's first review target period of 10 months.
Innovative Pharmaceutical Research Institute
The Innovative Drug Research Institute of Poly focuses on developing novel boron carriers for Boron Neutron Capture Therapy (BNCT). The team is dedicated to developing drug delivery systems with tumor-targeting functions, using various technologies such as polymer materials, biomolecules, and nanotechnology to achieve tumor enrichment of drugs, improve the efficacy of BNCT, and further expand its indications. The team has been well-equipped with experienced and skilled personnel in drug design, pharmacology and toxicology research, CMC and etc. Meanwhile, the research institute has established strong partnerships with multiple well-known research institutions, such as the Institute of High Energy Physics of the Chinese Academy of Sciences and Zhejiang University, to jointly promote the development of novel boron carriers. Currently, the team has multiple new drug pipelines for boron carriers and a fluorescent/magnetic resonance bimodal contrast agent project in pre-clinical research stage .
Drug Delivery R&D Institute
The Drug Delivery R&D Institute of Poly is to independently or collaboratively develop novel and efficient nucleic acid drug delivery systems that can break through patent barriers, as well as register high-end nucleic acid drug delivery excipients as pharmaceutical excipients.The team is dedicated to the development of lipid nanoparticle (LNP) delivery systems, and gradually exploring the application of delivery systems such as liposomes, polymers, and liposome-polymers in the fields of infectious disease vaccines, tumor vaccines, and drug and protein replacement therapies. The current research team consists of 10 members, including 2 PhDs and 7 master's degree holders, with 90% of the team having a master's or PhD degree. The team has already established research platforms for microfluidic encapsulation of nucleic acids, quality control of nucleic acid raw materials and formulations, and in vitro efficacy, pharmacology, and toxicology evaluation of nucleic acid drugs.
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