Our Services
Integrated End-to-End Solutions
PHMO has established a collaborative R&D and manufacturing ecosystem that transcends the traditional supplier model. Starting from early-stage R&D as the innovation launchpad, we leverage efficient process development and agile custom synthesis capabilities to seamlessly bridge the gap to large-scale commercial production, offering true end-to-end CDMO services. Our core strength integrates proprietary R&D with a global supply network, ensuring consistent quality from grams to tons while dynamically responding to evolving client needs. At the outset of any collaboration, we execute comprehensive confidentiality agreements and implement robust information security and confidentiality management systems.
Discovery
Our Objective
To provide a solid chemical foundation and high-quality candidate molecules for the discovery phase of innovative drugs, accelerating our clients' journey from concept to preclinical studies.
What We Offer
Target Analysis & Requirement Confirmation
Collaborate closely with clients to define the target molecule's structure, key physicochemical properties, and preliminary biological activity goals.
Synthetic Route Design & Scouting
Leverage our extensive building block library and cutting-edge synthetic expertise to design and rapidly screen multiple efficient and innovative synthetic routes.
Custom Building Block Synthesis
Provide custom synthesis of structurally diverse, high-purity core molecular fragments, offering modular solutions for complex molecule assembly.
Preliminary Process Feasibility Assessment
Conduct early-stage assessments of preferred routes for process safety, cost, and scalability, de-risking subsequent development.
Sample Delivery & Support
Deliver research-grade API and key intermediate samples (from milligram to gram scale) that meet rigorous standards, supporting your efficacy, pharmacokinetic, and toxicology screening studies.
Why Partner with PHMO
Expert Synthetic Chemistry Capabilities
Extensive experience in handling challenging chemistries, including fluorine chemistry, boron chemistry, anhydrous/oxygen-free operations, high-pressure hydrogenation, and the safe synthesis of hazardous compounds (e.g., diazomethane).
Efficient Route Scouting Platforms
Utilize advanced technology platforms such as high-throughput screening, flow chemistry, and photochemistry to significantly shorten the discovery and optimization timeline for candidate molecules.
Broad Target Experience
Proven experience in molecular design across multiple key therapeutic areas, involving hundreds of targets such as KRAS, PI3K, Bcl-2, HDAC, BET, CDK, JAK, ERK, EGFR, GSK-3, and STING.
Integrated Solid-State Research
Offer early-stage solid-state chemistry studies, including polymorph and salt screening, to provide critical data for candidate selection.
Process Development
Our Objective
We are dedicated to transforming candidate molecules into industrial production processes with superior commercial competitiveness. Our focus is on robustness, scalability, and cost-effectiveness, ensuring a seamless transition from the laboratory to the manufacturing plant, thereby providing a reliable supply for clinical trials and the global market.
What We Offer
Process Intensification & Innovation
Going beyond simple optimization, we develop innovative synthetic routes that are both intellectually property (IP)-friendly and economically viable, building fundamental advantages in cost and freedom to operate.
Risk-Based Process Characterization
Utilizing strategies like Design of Experiments (DoE), we systematically identify and define Critical Process Parameters (CPPs), establishing a scientific Proven Acceptable Range (PAR) to ensure process robustness and batch-to-batch consistency.
Inherently Safer Process Design
Comprehensive calorimetric analysis is integrated early in development to proactively identify and control thermal hazards, ensuring process intrinsic safety and de-risking future scale-up.
Process-Aligned Analytical Control
We develop and validate analytical methods that are closely linked to the manufacturing process, establishing a sound Quality Control Strategy to ensure product quality meets global regulatory standards.
Green & Sustainable Design
Green chemistry principles are embedded into process design to reduce environmental impact, while simultaneously enhancing overall process efficiency and economics through simplified purification and improved yields.
Why Partner with PHMO
Commercial-Focused Process Design
We begin with the end in mind. Our processes are developed with a commercial perspective, fully considering raw material availability, equipment compatibility, and production costs from the outset to ensure exceptional commercial viability.
Seamless Technology Transfer
Our extensive scale-up experience and deep understanding of cGMP enable efficient and compliant technology transfer from the lab to the production floor, accelerating your project timeline.
Robust Impurity Control & Justification
We possess exceptional capabilities in impurity identification, synthesis, and characterization, enabling us to establish scientifically rigorous control strategies for various impurities, including genotoxic impurities, and effectively support regulatory submissions.
Integrated CMC & Regulatory Support
We offer integrated services covering the preparation of toxicology and clinical trial APIs and the authoring of CMC documentation in both Chinese and English. Our familiarity with global regulations (China, US, EU, etc.) facilitates a smoother regulatory review process.
Manufacturing
Our Objective
To establish a reliable and efficient end-to-end production system that enables high-quality, stable, and scalable supply from clinical trial materials to commercial products, fully ensuring the supply chain security and market demand of our global partners.
What We offer
Technology Transfer & Process Validation
Systematically receive and validate developed processes, conducting crucial scale-up studies and registration batch production at our pilot plants to ensure process robustness in large-scale manufacturing.
GMP-Compliant Production
Execute standardized batch production procedures in multi-purpose workshops under strict cGMP guidelines, enabling stable output from kilogram to hundred-ton scale.
End-to-End Quality Control
Implement a full-spectrum quality monitoring system covering from starting materials and intermediates to final product release, ensuring every batch complies with global regulatory requirements.
Product Lifecycle Management
Conduct continuous process monitoring and optimization for marketed products, driving cost reduction and enhancing product competitiveness through lean management and supply chain coordination.
Stable Supply Chain Assurance
Ensure long-term, stable product supply through clear capacity planning and flexible production scheduling, effectively responding to market fluctuations.
Why Partner with PHMO
Proven Scale-Up Capability
Possess validated ton-scale production capacity and extensive experience in seamless scale-up from gram to ton level, ensuring efficient technology transfer from lab to plant.
Stringent Quality Management System
Maintain a GMP quality system compliant with international standards (China, US, EU, etc.), with comprehensive audit readiness and extensive experience in regulatory inspections.
Robust Capacity & Delivery Assurance
Leverage a strategically organized production base network and flexible scheduling to rapidly respond to client needs and ensure on-time delivery.
Integrated EHS Management
Embed Environmental, Health, and Safety principles into all operational aspects to ensure safe, environmentally friendly, and sustainable manufacturing processes.
Continuous Cost Optimization
Deliver commercial products with long-term cost advantages through economies of scale, process optimization, and supply chain management.
Custom Synthesis
Objective
To provide clients with efficient synthetic solutions for specific molecules, particularly those that are highly challenging and of high value-added.
What We Offer
Client Requirement Analysis & Project Initiation
Clarify the target molecule's structure, purity requirements, delivery quantity, and timeline.
Professional Synthetic Route Design
Our experienced team of chemists designs customized synthetic pathways tailored to the molecule's characteristics (e.g., chiral centers, heterocycles, specific functional groups).
Lab-Scale Synthesis & Optimization
Rapidly execute and optimize the synthetic route in the laboratory, preparing the first batch of samples for client confirmation.
Process Streamlining & Scale-Up
Scale up the laboratory process with necessary simplifications for the required quantities, producing in kilogram-scale labs or pilot plants.
Purification & Delivery
Utilize purification techniques such as crystallization, column chromatography, and distillation to ensure the product meets the agreed purity, followed by timely delivery.
Expert Reaction Technologies
Friedel-Crafts Reactions, Halogenation Reactions, Grignard Reactions
Coupling Reactions (e.g., Suzuki, Heck, Sonogashira)
Chiral Asymmetric Synthesis (e.g., Asymmetric Reduction, Alkylation)
Heterocyclic Compound Synthesis
Reduction Reactions, Hofmann Rearrangement, etc.
CDMO Services
End-to-End Service Process
Concept & Feasibility Stage
Participate in clients' early R&D discussions, providing analysis of chemical and process feasibility.
Development & Scale-Up Stage
API Process Development
Complete process development and production for samples from preclinical to Phase I, II, and III clinical trials.
Analytical Method Development & Validation
Establish and validate quality standards and analytical methods compliant with GMP requirements.
Regulatory Support
Prepare Chemistry, Manufacturing, and Controls (CMC) data required for the Common Technical Document (CTD).
Production & Supply Stage
Clinical Sample Supply
Manufacture APIs for various phases of clinical trials.
Commercial Validation Batch Production
Complete Process Performance Qualification (PPQ) batch production.
Long-Term Commercial Supply
Enter into long-term supply agreements to ensure continuous and stable drug production and global supply.
Lifecycle Management Stage
Provide post-approval process change support, secondary process optimization, and global registration maintenance services.
Why Partner with PHMO
Integrated Platform
Combines R&D, process development, production, quality control, and regulatory affairs in a single platform.
Proven Track Record
Successfully supported the global registration and market launch of multiple innovative and generic drug projects.
Flexible Collaboration
Offers various cooperation models, from "Technology Transfer + Production" to "Joint Submission," tailored to client needs.