Advanced Technologies and State-of-the-Art Facilities for Agile and Flexible API and HPAPI Manufacturing
At AGC Pharma Chemicals, we integrate cutting-edge technologies and facilities for small molecule manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates. Our infrastructure is purpose-built to deliver services that ensure flexibility, scalability and quality, enabling us to meet the diverse needs of our clients and bring their pharmaceutical innovations to life.
Our integrated pharmaceutical manufacturing facilities combine R&D, GMP manufacturing facilities, pilot-scale operations and commercial production within a single infrastructure, allowing customers to move efficiently from early development to commercial manufacturing while maintaining process consistency and manufacturing excellence.
We have systematically adapted our entire development and manufacturing chain to OEB5 standards, from a new R&D to commercial production, ensuring consistent containment capabilities throughout the entire process.
This integrated approach also supports both conventional small molecule manufacturing and dedicated high potency API manufacturing projects under appropriate containment strategies.
Whether you are in the early clinical stage or moving towards full-scale commercial production, our comprehensive suite of services and state-of-the-art facilities are here to support you every step of the way.
R&D Facilities for Manufacturing Readiness
R&D center
The R&D center at AGC Pharma Chemicals is a hub of innovation, where cutting-edge research meets practical application. Our scientists work with state-of-the-art technology to develop and optimize API synthesis, focusing on delivering robust and scalable processes that meet the most stringent pharmaceutical industry standards in safety and quality.
Our R&D activities provide the manufacturing foundation for successful small molecule manufacturing projects by generating scalable processes that can be efficiently transferred into GMP manufacturing facilities.
Our R&D center provides route scouting, process definition and optimization, as well as stability studies covering from early phases to commercialization projects.
During early phases I, II and III, the R&D center can conduct purging studies, process safety, solid form studies and impurities identification, analysis and fate.
Later on, the R&D center focuses on process development and definition (NOR/PAR/CSS), cGMP-compliant analytical method development and scale-up modeling.
These activities are designed to facilitate efficient transfer into our GMP manufacturing facilities while reducing manufacturing risks during scale-up.
At the end of the process, the R&D center ensures fast-track tech transfer to kilo lab/pilot plant/production and stability studies throughout the Commercial phase.
By operating within the same integrated infrastructure as our Kilolab, Pilot Plant and commercial manufacturing facilities, process knowledge is maintained throughout every manufacturing stage, improving continuity and reducing technology transfer complexity. ”
Would you like more details about our R&D capabilities? Feel free to contact us.
GMP Manufacturing Facilities for Scale-Up
cGMP Kilolab
Our facility is designed to mimic a commercial production plant, ensuring strict compliance with current cGMP and meeting the highest standards in pharmaceutical architecture.
The production environment includes Class D/ISO 8 clean rooms, equipped with 100% fresh air systems filtered through HEPA filters, and is fully compliant with OEB5 handling requirements (0.1-1 μg/m³).
These GMP manufacturing facilities allow manufacturing processes to be evaluated under production-like conditions before moving into larger-scale operations, supporting a smooth transition toward commercial small molecule manufacturing.
The facility features dedicated airlocks for both material and personnel flow and a mist shower, ensuring controlled access and minimizing contamination risks. It is also designed for ATEX Zones, allowing safe operations in environments with potentially explosive atmospheres.
Our process equipment includes a 23L/50L/70L reactor, ideal for high-capacity reactions, and a filter dryer capable of producing up to 7 kg of solid product, including cryogenic projects. The flexible equipment configuration allows for easy dismounting and maintenance.
Additionally, the facility is equipped with a control unit, a safety workbench for lab-scale work and analytical sampling, an isolator for dispensing, and dedicated support areas such as personnel/material airlocks and a washing room – all contributing to a seamless and compliant small molecule manufacturing process, including dedicated high potency API manufacturing projects requiring OEB5 containment.
The Kilolab plays a central role in preparing manufacturing processes for larger production volumes while maintaining containment, product quality and operational flexibility.
cGMP Pilot Plant
The cGMP Pilot Plant at AGC Pharma Chemicals, with reactors that have a maximum capacity of 400 L and a filter dryer with a capacity of 300 L, is where lab-scale innovations are transformed into commercial reality.
Operating under strict compliance with cGMP, this facility is equipped to handle small to medium-scale productions, ensuring that processes are fully optimized and ready for large-scale implementation. The facility is fully compliant with OEB4 handling requirements.
As part of our integrated GMP manufacturing facilities, the Pilot Plant provides an important bridge between development activities and commercial manufacturing, enabling reliable scale-up while maintaining process reproducibility and manufacturing efficiency.
The facility supports both conventional small molecule manufacturing and projects involving highly potent compounds under dedicated containment strategies.
cGMP Multi-purpose manufacturing site
Our multipurpose plant is designed for flexibility and scalability, enabling efficient production and offering a broad technology portfolio.
Featuring advanced equipment and adaptable production lines, the facility includes a cGMP Pilot Plant with HAPI capabilities, and also a cGMP Micronization Plant with HAPI capabilities.
These specialized areas allow for seamless transitions between different stages of the manufacturing process, ensuring timely and cost-effective delivery of high-quality products.
Our advanced manufacturing facility integrates an OEB5 HPAPI bay with reactors volumes of 1.5 m³.
Together, these pharmaceutical manufacturing facilities provide customers with flexible production options ranging from early manufacturing campaigns to full commercial volumes.
The combination of dedicated manufacturing areas, scalable equipment and specialized containment technologies enables AGC Pharma Chemicals to support increasingly complex small molecule manufacturing projects while maintaining operational efficiency and regulatory compliance.
We continue to invest in our infrastructure and increase our capacity to provide more solutions and technologies.
Continuous investment in our GMP manufacturing facilities allows us to expand capacity, introduce new technologies and support the evolving needs of pharmaceutical manufacturing.
Discover how we are expanding our facilities to better serve you.
API Micronization Services
cGMP Micronization plant
Our micronization technology is built around the state-of-the-art Hosokawa Alpine Multi-Mill, a dual system designed for versatile applications in particle engineering and solid-state processing.
This multi-process system includes opposed bed jet milling and mechanical impact milling combined with a classifier, providing precise particle size reduction and enhanced flexibility in handling various APIs.
Leveraging the latest technology, it ensures optimal solid-state stability and controlled particle engineering to meet the unique needs of each API.
With a feed capacity ranging from 30 to 50 kg/h and an integrated batch homogenizer, this technology guarantees consistent quality and performance in every batch.
Our dedicated API micronization capabilities allow particle size to be precisely controlled according to the specific requirements of each compound. This contributes to consistent product performance while supporting downstream pharmaceutical manufacturing operations.
API micronization is an important manufacturing step for many small molecule products, helping optimize particle size distribution while maintaining the desired solid-state characteristics of the active ingredient.
Safety is a top priority, and our micronization unit is engineered to meet stringent OEB4 containment requirements (1-10 µg/m³). It features an isolator for product loading and a packing unit that utilizes a continuous liner system with auto-weight adjustment and a sampling device, all designed for closed product handling. The unit operates within an ATEX zone and is equipped with cleaning-in-place capabilities for solvent use, ensuring both safety and efficiency in processing.
As part of our GMP manufacturing facilities, the micronization plant combines advanced containment, precise particle engineering and scalable manufacturing capabilities for a wide range of pharmaceutical compounds.
High Potency API Manufacturing
HAPI and HPAPI capabilities
We offer robust capabilities in Highly Potent Active Pharmaceutical Ingredients (HAPI) and High Potency API (HPAPI) production, with scalable solutions ranging from grams to full commercial production in tons.
Our dedicated high potency API manufacturing infrastructure has been developed to safely support increasingly complex pharmaceutical compounds while maintaining strict containment and operational flexibility throughout every manufacturing stage.
Our facilities are meticulously designed for safety and compliance, featuring different containment strategy approaches to handle high-potency substances safely, including OEB5 and OEB4 environments:
- Our R&D laboratory is equipped with advanced OEB5 containment systems.
- Our cGMP Kilolab is fully compliant with OEB5 handling requirements (0.1-1 μg/m³).
- The cGMP Pilot Plant is fully compliant with OEB4 handling requirements.
- Our cGMP Micronization Plant is engineered to meet stringent OEB4 containment requirements (1-10 µg/m³)
- Advanced manufacturing facility with an OEB5 HPAPI bay with reactors volumes of 1.5 m³.
- Our IPC/QC laboratories support all development phases.
These dedicated manufacturing areas allow AGC Pharma Chemicals to perform highly potent API manufacturing under appropriate containment strategies while protecting operators, products and the manufacturing environment.
Our infrastructure has been designed to maintain segregation between conventional small molecule manufacturing and highly potent API manufacturing activities, ensuring that each project is managed using the appropriate containment approach according to compound potency.
By integrating OEB5 laboratories, Kilolab operations, pilot-scale manufacturing, micronization and commercial production within the same organization, AGC Pharma Chemicals provides a consistent pathway for high potency API manufacturing from early manufacturing activities through commercial supply.
Through Safety and Toxicological Assessments and a commitment to excellence in Process Development, AGC Pharma Chemicals ensures safe, flexible, and compliant solutions for high potency API manufacturing and highly potent API manufacturing projects. “
Fluorination
Adding fluorinated molecules to produce active pharmaceutical ingredients (APIs), intermediates and starting materials is a highly specialized field that complements our small molecule manufacturing capabilities.
AGC Pharma Chemicals has a long history and experience in handling these compounds. We offer specialized fluorination capabilities, leveraging our extensive experience in this area. AGC Pharma Chemicals handles fluorinated synthetic technologies as follows:
- Various types of fluorinating agents (HF, F2 gas, nucleophilic/electrophilic fluorination agents)
- Innovative fluorination technology
- Nucleophilic fluorination
- Halogen exchange
- Diazo-fluorination
・ Electrophilic fluorination
・ Electrolytic fluorination - Use of plentiful fluorine-containing building blocks
We can offer our capabilities and experience related to fluorinated substances from Spain and Japan. “
Other Special Technologies
Flow chemistry
Bromination
Cryogenic reactions
Hazardous reactions (e.g., cyano, diazo, Cl2 reactions)
General organic reaction
- Friedel-Crafts
- Organometallic chemistry
・ Grignard reaction
・ Lithiation
・ Cross coupling (Cu, Ni, Pd catalyzed) - Amidation
- Oxidation/reduction
- Hydrogenation
