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普洛藥業(yè)
DS Technology Platforms
Flow Chemistry Synthetic Biology & Biocatalysis Crystallization & Particle Engineering Peptide High Potency Compound Conjugate Library Service Oligonucleotide Synthesis Preparation & Purification
High Potency 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).
普洛藥業(yè)
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
普洛藥業(yè)
普洛藥業(yè)
普洛藥業(yè)
普洛藥業(yè)
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
普洛藥業(yè)
普洛藥業(yè)
普洛藥業(yè)
普洛藥業(yè)
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
普洛藥業(yè)
Isolator for R&D
普洛藥業(yè)
Isolator for scale up (50 g-500 g)
普洛藥業(yè)
Isolator with tray dryer
普洛藥業(yè)
Tray lyophilizer (10 g - 120 g, 0.5㎡)
普洛藥業(yè)
Flask lyophilizer (0.1 g - 30 g)
普洛藥業(yè)
Reactor controller
普洛藥業(yè)
Prep-HPLC
普洛藥業(yè)
GC / HPLC / IR / UV
Case: OEB 5 (Phase II, ADC-Payload & Linker)
普洛藥業(yè)
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