{"id":130,"date":"2024-04-19T16:25:04","date_gmt":"2024-04-19T07:25:04","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=130"},"modified":"2024-11-26T13:52:29","modified_gmt":"2024-11-26T04:52:29","slug":"medium_molecule_drugs","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/medium_molecule_drugs\/","title":{"rendered":"Medium-Molecule API Manufacturing Facility"},"content":{"rendered":"<div id=\"medium_molecule_drugs\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/\">Sectors<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/\">Pharmaceuticals and Medical Devices<\/a>\/<\/li>\n<li>Medium-Molecule API Manufacturing Facility<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Pharmaceuticals and Medical Devices<\/span><br class=\"wpTag\">Medium-Molecule API <br \/>Manufacturing Facility<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Pharmaceuticals and Medical Devices Medium-Molecule API Manufacturing Facility\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-field04.webp\" alt=\"Pharmaceuticals and Medical Devices Medium-Molecule API Manufacturing Facility\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-field04.webp\" alt=\"Pharmaceuticals and Medical Devices Medium-Molecule API Manufacturing Facility\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<div class=\"comTableDBox\">\n<div class=\"innerBox\">\n<table class=\"tableD\">\n<thead>\n<tr>\n<th><span class=\"en\">Classification Name<\/span><\/th>\n<th><span class=\"txt\">Low Molecular Weight<\/span><\/th>\n<th><span class=\"txt\">Medium Molecular Weight<\/span><\/th>\n<th><span class=\"txt\">High Molecular Weight<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<th><span class=\"en\">Molecular Weight<\/span><\/th>\n<td>\n<p class=\"priceTxt\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/dot_img01.webp\" alt=\"\"><span class=\"wpTag\">\uff5e500<\/span><\/p>\n<\/td>\n<td>\n<p class=\"priceTxt\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/dot_img02.webp\" alt=\"\"><span class=\"wpTag\">500\uff5e2,000<\/span><\/p>\n<\/td>\n<td>\n<p class=\"priceTxt\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/dot_img03.webp\" alt=\"\"><span class=\"wpTag\">2,000\uff5e<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<th><span class=\"en\">Examples<\/span><\/th>\n<td>\n<ul class=\"txtUl\">\n<li>Synthetic Organic Pharmaceuticals<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul class=\"txtUl\">\n<li>eptide Pharmaceuticals<\/li>\n<li>Nucleic Acid Pharmaceuticals<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul class=\"txtUl\">\n<li>Antibody Drugs<\/li>\n<li>Vaccines<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<th><span class=\"en\">Main Manufacturing Methods<\/span><\/th>\n<td>\n<ul class=\"txtUl\">\n<li>Organic Synthesis<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul class=\"txtUl\">\n<li>Peptide Synthesis<\/li>\n<li>Nucleic Acid Synthesis<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul class=\"txtUl\">\n<li>Microbial Culture<\/li>\n<li>Animal Cell Culture<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p class=\"btmTxt\">Medium-Molecule APIs are considered to have a molecular weight of approximately 500 to 2,000. Since the molecular weight of organic synthesis APIs is below 500, and that of APIs produced by microbial or animal cell culture is around 150,000, the former are called Low-Molecule APIs and the latter High-Molecule APIs. The intermediate ones are referred to as middle molecular weight APIs. Medium-Molecule APIs are broadly divided into peptide pharmaceutical APIs and nucleic acid pharmaceutical APIs.<\/p>\n<\/div>\n<div class=\"comBorBox\">\n<section class=\"sec01\">\n<h2 class=\"headLine05\">Types and Characteristics of Medium-Molecule APIs<\/h2>\n<div class=\"subBox\">\n<h3 class=\"headLine06\">Peptide Pharmaceutical APIs<\/h3>\n<div class=\"comImgBox comImgBox02\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/img01.webp\" alt=\"Peptide Pharmaceutical APIs\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">Peptide pharmaceutical APIs are obtained by synthesizing peptides through solid-phase or liquid-phase reactions that bond 20 types of amino acids. The synthesized peptides need to have the structure of the active sites of proteins that are usually generated in the body. Generally, the peptides are often cyclic to make them less susceptible to degradation and modification.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subBox\">\n<h3 class=\"headLine06\">Nucleic Acid Pharmaceutical APIs<\/h3>\n<div class=\"comImgBox comImgBox02\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/img02.webp\" alt=\"Nucleic Acid Pharmaceutical APIs\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">Nucleic acid pharmaceuticals make use of nucleic acids such as DNA and RNA, which carry genetic information, in medicinal applications. Since nucleic acid pharmaceuticals can be manufactured with synthetic techniques similar to those used for small molecule pharmaceuticals, they can be produced at a lower cost compared to high molecular weight APIs. Moreover, they can target molecules like mRNA and miRNA, which cannot be targeted by either small or high molecular weight pharmaceuticals.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sec02\">\n<h2 class=\"headLine05\">Manufacturing Facilities for Middle Molecular Weight APIs ~Key Points in Construction~<\/h2>\n<div class=\"comGrayImgBox\">\n<h3 class=\"headLine06\">Laboratory Scale Facility Adaptation<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark01.webp\" alt=\"Laboratory Scale Facility Adaptation\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">During the drug discovery phase of APIs, trial production uses test tubes and Erlenmeyer flasks. This is the so-called laboratory scale, or beaker scale. At this scale, commercially available test equipment is often installed, and the facility (including building, HVAC, sanitary, and electrical systems) must be designed to accommodate these devices in a user-friendly configuration, taking into account HSSE (Health, Safety, Security, Environment) considerations.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Adaptation for Clinical Trial Drugs and Pilot Plants<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark02.webp\" alt=\"Adaptation for Clinical Trial Drugs and Pilot Plants\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">To manufacture pilot plants or clinical trial drug plants at the level of several kilograms to tens of kilograms, compliance with GMP is necessary. Especially for the multi-production of formulations whose safety and other aspects have not been confirmed, it is crucial to logically assemble and construct a system addressing various measures such as cleanroom structure, HVAC systems, equipment cleanability, and containment of highly active substances.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Chemical Hazard Adaptation<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark03.webp\" alt=\"Chemical Hazard Adaptation\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Paradoxically, the targets of middle molecular weight APIs, which are a new technology, often have high pharmacological efficacy. This is because APIs with low pharmacological efficacy have a poor return on investment. As a result, middle molecular weight APIs often require measures against chemical hazards. Regulations for these chemical hazards are independently established by each country, making global compliance challenging.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Hazardous Materials Adaptation<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark04.webp\" alt=\"Hazardous Materials Adaptation\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Since middle molecular weight APIs are produced by chemical synthesis, a large volume of solvents is used. Consequently, the manufacturing facility must comply with the Fire Service Act as a hazardous materials manufacturing site or a general handling site. Specifically, structures like hydrogenation rooms must be designed to withstand explosion pressures, and features like venting shafts must be installed to release explosion pressures. Coordination with fire authorities is necessary for these measures, so reliable design by knowledgeable and experienced engineers is required.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Cleaning Adaptation<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark05.webp\" alt=\"Cleaning Adaptation\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">For middle molecular weight APIs, where amino acids or nucleic acids are bonded stepwise, reaction tanks are often reused. There is a concern that reaction residues may adversely affect subsequent reactions. Thus, cleaning between processes and campaigns is important.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Continuous Production<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark06.webp\" alt=\"Continuous Production\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Middle molecular weight APIs, like low and high molecular weight APIs, are beginning to explore continuous production techniques to improve production efficiency. Specifically, techniques such as continuous-flow hydrogenation reactions and membrane concentration are being adopted. To achieve continuous production, quality management through Quality by Design (QbD) and inline monitoring via Process Analytical Technology (PAT) are key points.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Scale-Up<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/medium_molecule_drugs\/mark07.webp\" alt=\"Scale-Up\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">From the drug discovery phase to clinical trials and market launch, scale-up progresses from beaker to bench (collectively sometimes referred to as kilo lab) to pilot to launch to commercial scale. Ensuring product quality and production efficiency during this scale-up process is a key point.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sec03\">\n<h2 class=\"headLine05\">Strengths of CM Plus<\/h2>\n<div class=\"comImgArea\">\n<div class=\"subArea\">\n<h3 class=\"headLine06\">\u2460Engineering + CM Method<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">The CM method is a project management system that integrates the client\u2019s perspective with designers to operate and manage projects transparently, ensuring success from the aspects of QCD (Quality, Cost, Delivery) + EHS (Environment, Health, Safety). Professionals, including Construction Managers (CMr) who specialize in management, work on behalf of the client.<\/p>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\"><span class=\"subSpan\">Construction Managemnet by CM Plus<\/span><\/a><\/div>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo07.webp\" alt=\"\u2460Engineering + CM Method\"><\/div>\n<\/div>\n<div class=\"imgInn imgInnR flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">At CM Plus, we conduct engineering (design) in-house. We have engineers who are well-versed in manufacturing processes, equipment and facilities, construction, and manufacturing support facilities (such as electrical systems, HVAC, and utilities). This allows us to oversee the entire facility from the initial planning stages, enabling the construction of integrated and cohesive layout facilities.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img09.webp\" alt=\"\u2460Engineering + CM Method\"><\/div>\n<\/div>\n<\/div>\n<div class=\"subArea\">\n<h3 class=\"headLine06\">\u2461Comprehensive Coordination of Production Equipment and Building Facilities<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">With a focus on designing from the production process perspective, we execute designs that start from the internal aspects like building production equipment lines, layouts, and internal flow\/logistics, leading to the creation of API (Active Pharmaceutical Ingredient) factories that are in harmony with the production system. Our planning extends to the intangible aspects of the production system as well.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo14.webp\" alt=\"\u2461Comprehensive Coordination of Production Equipment and Building Facilities\"><\/div>\n<\/div>\n<div class=\"imgInn imgInnR flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">Our team consists of project managers and professional engineers experienced in factory construction across various fields. This allows us to manage the overall project schedule comprehensively, including not only the building and production support facilities but also providing support for the procurement, production management, and coordination of delivery plans of production equipment.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img11.webp\" alt=\"\u2461Comprehensive Coordination of Production Equipment and Building Facilities\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sec04\">\n<h2 class=\"headLine05\">Services provided by CM Plus<\/h2>\n<div class=\"comFlowListBox\">\n<ul class=\"comFlowList\">\n<li class=\"li01 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\"><span class=\"txtSpan\">Business Concept<\/span><\/a><\/li>\n<li class=\"li02 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\"><span class=\"txtSpan\">Conceptual Design<\/span><\/a><\/li>\n<li class=\"li03 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\"><span class=\"txtSpan\">Basic Design<\/span><\/a><\/li>\n<li class=\"li04 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\"><span class=\"txtSpan\">Procurement<\/span><\/a><\/li>\n<li class=\"li05 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Detailed Design \/ Production Management<\/span><\/a><\/li>\n<li class=\"li06 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Construction<\/span><\/a><\/li>\n<li class=\"on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\"><span class=\"txtSpan\">Trial Operation<\/span><\/a><\/li>\n<li class=\"liStyle on\"><a href=\"#\" class=\"no\"><span class=\"txtSpan\">Operation<\/span><\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"comStepBox\">\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">01<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img01.webp\" alt=\"Business Concept\"><\/span><\/p>\n<h2 class=\"headLine06\">Business Concept<\/h2>\n<\/div>\n<p class=\"wpTag\">We listen to our clients\u2019 requirements and create deliverables such as a list of key equipment, PFD (Process Flow Diagrams), and conceptual layouts to visualize the investment image. Based on the created deliverables, we calculate an approximate investment amount to support investment decisions (Feasibility Study, F\/S).<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox02\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">02<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img02.webp\" alt=\"Conceptual Design\"><\/span><\/p>\n<h2 class=\"headLine06\">Conceptual Design<\/h2>\n<\/div>\n<p class=\"wpTag\">In the basic planning (concept design) phase, we compile the client\u2019s requirements and requests through discussions and document them as a User Requirement Brief (URB). We also calculate an approximate project cost based on the contents of the URB.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox03\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">03<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img03.webp\" alt=\"Basic Design\"><\/span><\/p>\n<h2 class=\"headLine06\">Basic Design<\/h2>\n<\/div>\n<p class=\"wpTag\">In the basic design phase, based on the contents of the URB, we create the necessary drawings and specifications for effective solicitation. Specifically, in the process design, we produce PFDs, P&#038;IDs (Piping and Instrumentation Diagrams), data sheets, time schedules (OTS), and equipment specifications required for plant design. We also organize regulations and standards related to facility design and construction, government applications, and environmental conditions, support setting up the project\u2019s master schedule and overall execution plan, and assist with preparations and support for prior coordination with relevant government agencies and utility providers.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox04\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">04<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img04.webp\" alt=\"Procurement\"><\/span><\/p>\n<h2 class=\"headLine06\">Procurement<\/h2>\n<\/div>\n<p class=\"wpTag\">In the purocurement phase, to build an optimal execution system tailored to the project\u2019s characteristics, we study the order and service divisions and prepare solicitation specifications and procurement specifications based on these considerations. We then solicit quotations from construction companies. We support the client in selecting a construction company by conducting technical evaluations and quotation assessments on the proposals presented by the construction companies and summarizing them in a report.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox05\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">05<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img05.webp\" alt=\"Detailed Design \/ Production Management\"><\/span><\/p>\n<h2 class=\"headLine06\">Detailed Design \/ Production Management<\/h2>\n<\/div>\n<p class=\"wpTag\">In the detailed design and manufacturing management phase, we perform design supervision to ensure the construction company and production equipment suppliers reflect the URB, basic design documents, and various regulations in their designs and that progress is on schedule.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox06\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">06<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img06.webp\" alt=\"Construction and Installation Phase\"><\/span><\/p>\n<h2 class=\"headLine06\">Construction and Installation Phase<\/h2>\n<\/div>\n<p class=\"wpTag\">In the construction and installation phase, we perform construction supervision to ensure that the construction company reflects the URB, URS, detailed design documents, and various regulations in their work, and manage the quality of facilities and equipment. Additionally, a construction manager will reside on-site to manage construction status, progress, and changes from the client\u2019s perspective.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox07\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">07<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img07.webp\" alt=\"Trial operation\"><\/span><\/p>\n<h2 class=\"headLine06\">Trial operation<\/h2>\n<\/div>\n<p class=\"wpTag\">To carry out high-quality and efficient qualification, we provide services that suit the client\u2019s needs, reducing their burden by supporting the creation of a validation master plan and risk assessment from the planning stage and creating protocols for Qualification (DQ, IQ, OQ, PQ), and supporting the execution phase.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"comTxt operationTtl\">Facility Operation<\/p>\n<\/section>\n<\/div>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Client Testimonials<\/h2>\n<ul class=\"comFooUl comCaseListSml flex\">\n<li>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/voice\/cpmc\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2024\/05\/thumb-voice-chugai-1.jpg\" alt=\"Chugai Pharma Manufacturing Co., Ltd.\"><\/span><br \/>\n<span class=\"textBox\"><br \/>\n<span class=\"tag\"><span class=\"wpTag\" style=\"background-color: #217870;\">Engineering<\/span><\/span><br \/>\n<span class=\"ttl\">World Recognized Highly Pharmacologically Active Manufacturing Facility<br \/>\n\uff5eBreaking new ground beyond the \u201cWall of 0.05\u03bcg\/m3<\/span><br \/>\n<span class=\"txt02\">Chugai Pharma Manufacturing Co., Ltd.<\/span><br \/>\n<\/span><br \/>\n<\/a>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Projects<\/h2>\n<ul class=\"comFooUl comCaseListSml flex\">\n<li>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/jitsubo\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/case_photo03.webp\" alt=\"Pharmaceuticals and Medical Devices\uff0fMedium-Molecule API\"><\/span><br \/>\n<span class=\"textBox\"><br \/>\n<span class=\"tag\"><span class=\"subSpan03\"> Pharmaceuticals and Medical Devices\uff0fMedium-Molecule API<\/span><\/span><br \/>\n<span class=\"ttl\">Cost reduction through separate sub-contracting<\/span><br \/>\n<span class=\"txt02\">JITSUBO Co., Ltd.<\/span><br \/>\n<\/span><br \/>\n<\/a>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/span><br \/>\n<span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/span><br \/>\n<span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Useful Information<\/h2>\n<p class=\"wpTag\">Please refer to the articles related to active pharmaceutical ingredients and medium molecules on our information dissemination site, \u201cGMP Platform\u201d.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo07.webp\" alt=\"\u201cHow to Build a Pharmaceutical Factory: Towards Project Success\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cHow to Build a Pharmaceutical Factory: Towards Project Success\u201d<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=6635\" target=\"_blank\" rel=\"noopener\u00a0noreferrer noopener\">[Chapter 4-4] \u2460 Medium Molecules<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo07.webp\" alt=\"\u201cHow to Build a Pharmaceutical Factory: Special Edition\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cHow to Build a Pharmaceutical Factory: Special Edition\u201d<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=6479\" target=\"_blank\" rel=\"noopener\u00a0noreferrer noopener\">Key Points for Basic Planning (Conceptual Design) of Active Pharmaceutical Ingredient Manufacturing Facilities<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo05.webp\" alt=\"\u201cHow to Build a Pharmaceutical Factory: Special Edition\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07 ttlStyle\">We have published a book in English. Please refer to this news.<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/news\/event\/2023_0609\/\">A presentation at ISPE Indonesia&#8217;s Annual Conference 2023<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo12.webp\" alt=\"\u201cManufacturing of Active Pharmaceutical Ingredients\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cManufacturing of Active Pharmaceutical Ingredients\u201d<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=279&#038;lang=ja\" target=\"_blank\" rel=\"noopener\u00a0noreferrer noopener\">[Part 1] Cost and Price of Active Pharmaceutical Ingredients<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese 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href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/energy_management\/\">Energy Management Solutions \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Home\/ Services\/ Engineering, Project Management\/ Sectors\/ Pharmaceuticals and Medical Devices\/ Medium-Molecule API Manufacturing Facility Pharmaceuticals and Medical DevicesMedium-Molecule API Manufacturing Facility Classification Name Low Molecular Weight Medium Molecular Weight High Molecular Weight Molecular Weight \uff5e500 500\uff5e2,000 2,000\uff5e Examples Synthetic Organic Pharmaceuticals eptide Pharmaceuticals Nucleic Acid Pharmaceuticals Antibody Drugs Vaccines Main Manufacturing Methods Organic Synthesis Peptide Synthesis Nucleic Acid Synthesis Microbial Culture Animal Cell Culture Medium-Molecule APIs are considered to have a molecular weight of approximately 500 to 2,000. Since the molecular weight of organic synthesis APIs is below 500, and that of APIs produced by microbial or animal cell culture is around 150,000, the former are called Low-Molecule APIs and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":120,"menu_order":37,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[9,11],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medium-Molecule API Manufacturing Facility\uff5cProduction Facilities\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"CM Plus provides total support for the construction of production facilities in the pharmaceutical and medical device fields. 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