• 尊龙凯时人生就是搏·(中国区)官方网站

      Apeloa
      尊龙人生就是搏中国区药业
      DS Technology Platforms
      Flow Chemistry Synthetic Biology & Biocatalysis Highly Potent Compound Peptide TPD/PROTAC Oligonucleotide Synthesis Crystallization & Particle Engineering Preparation & Separation
      Highly Potent Compound Platform
      Apeloa Highly Potent Compound Platform is dedicated to the development and manufacturing of highly potent compounds (e.g., toxins and linkers of ADC drugs) and use appropriate containment, controls, and management systems to ensure compliance with Industrial Hygiene. Apeloa has developed comprehensive EHS and safety systems combined with leading edge manufacturing suites using isolator and segregation technologies to deliver high-quality products. With the capability to safely produce a range of highly potent molecules in virtually any scale, Apeloa is an ideal partner for development and manufacturing of Registered Starting Materials (RSMs), Intermediates, and Highly Potent API (HPAPIs).
      尊龙人生就是搏中国区药业
      Team
      Apeloa Highly Potent Compound Platform is led by a team of highly experienced professionals in organic synthesis, chemical engineering, process development, optimization, and scale-up. The team has successfully executed numerous highly potent compound projects, and
      Services
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      Apeloa offers comprehensive services for HPAPI development and manufacturing, including: • Synthetic route design and selection • Process method development and demonstration • Analytical method development and pre-validation • Scale-up and commercial production
      Manufacturing Facility
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      尊龙人生就是搏中国区药业
      Our Highly Potent Compound manufacturing facilities consist of over six bays which are all separate closed systems hosting a total reactor volume of 75 m3. Three of the bays are designed to produce Registered Starting Materials (RSMs) and Intermediates rated up to OEB-4. There are several additional bays designated for the manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPIs) up to a rating of OEB-5. Our various segregated bays offer reaction, purification, filtration, washing & drying as well as some with crystallization, filtration, and grinding capabilities. Our Highly Potent API facilities are also equipped with a range of dedicated equipment to support production including distillation units, filter driers, conical driers (2000L HC22), horizontal scraper centrifuges (HC22), static tray ovens, and jet mills and hammer crusher equipment for grinding.
      Equipment
      Apeloa Highly Potent Compound Platform is equipped with state-of-the-art facilities, including:
      • Isolator for R&D
        Isolator for R&D
      • Isolator for scale up (50 g-500 g)
        Isolator for scale up (50 g-500 g)
      • Isolator with tray dryer
        Isolator with tray dryer
      • Tray lyophilizer (10 g - 120 g, 0.5㎡)
        Tray lyophilizer (10 g - 120 g, 0.5㎡)
      • Flask lyophilizer (0.1 g - 30 g)
        Flask lyophilizer (0.1 g - 30 g)
      • Reactor controller
        Reactor controller
      • Prep-HPLC
        Prep-HPLC
      • GC / HPLC / IR / UV
        GC / HPLC / IR / UV
      尊龙人生就是搏中国区药业
      Isolator for R&D
      尊龙人生就是搏中国区药业
      Isolator for scale up (50 g-500 g)
      尊龙人生就是搏中国区药业
      Isolator with tray dryer
      尊龙人生就是搏中国区药业
      Tray lyophilizer (10 g - 120 g, 0.5㎡)
      尊龙人生就是搏中国区药业
      Flask lyophilizer (0.1 g - 30 g)
      尊龙人生就是搏中国区药业
      Reactor controller
      尊龙人生就是搏中国区药业
      Prep-HPLC
      尊龙人生就是搏中国区药业
      GC / HPLC / IR / UV
      Case: OEB 5 (Phase II, ADC-Payload & Linker)
      尊龙人生就是搏中国区药业
      Main challenges
      • Complex purification process by column chromatogram in step 2 • Epimerization issue of compound E during deprotection in step 6
      Achievements
      • • Develop the crystallization process to avoid the column purification.
      • • Develop the flow chem. to minimize the issue of epimerization.
      • • 1kg under non-GMP and 5 kg under GMP condition