Advanced Technologies and State-of-the-Art Facilities for Agile and Flexible API Process Development and Manufacturing
At AGC Pharma Chemicals, we integrate cutting-edge technologies and facilities for our CDMO services in the process development and 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.
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 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 center provides route scouting, process definition and optimization and analytical method development, 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. 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.
Would you like more details about our R&D capabilities? Feel free to contact us.
cGMP Kilolab with HAPI
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). 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 API and HAPI manufacturing process.
cGMP Pilot Plant with HAPI
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.
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.
We continue to invest in our infrastructure and increase our capacity to provide more solutions and technologies.
Discover how we are expanding our facilities to better serve you.
cGMP Micronization plant with HAPI
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.
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.
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 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 cGMP Kilolab is fully compliant with OEB5 handling requirements (0.1-1 μg/m³).
- The cGMP Pilot Plant meets OEB4 requirements for handling potent compounds.
- Our cGMP Micronization Plant is engineered to meet stringent OEB4 containment requirements (1-10 µg/m³)
Through Safety and Toxicological Assessments and a commitment to excellence in Process Development, AGC Pharma Chemicals ensures safe, flexible, and compliant solutions for all HAPI and HPAPI needs.
Fluorination
Adding fluorinated molecules to produce active pharmaceutical ingredients (APIs), Intermediates and Starting Materials is a highly specialized field, and 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
