Research & Manufacturing
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Production
Our manufacturing plant fully complies with the highest standards of current Good Manufacturing Practices (cGMP).
All operations involving the final products, from crystallization to packaging, are performed in a ISO Class 8.5 area.
Reactions are run within a temperature range of -20°C to 180°C and pressure between full vacuum and 6 Bar_g.
All our facilities are continuously upgraded in order to provide our customers with best quality products.
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The finishing rooms enable us to handle dried products in line with the highest standards (ISO Class 8.5).
- Micronizers
- Roll compactors
- Temperature: ranging from -20°C to 180°C
- Pressures: from down to 5 mmHg and up to 6 Bar g
- Solid Handling areas
- Stainless steel, Glass, Glass-lined
- Centrifuges. Centrifuge
- Filters
- Rotary Vacuum Dryers
- Mills
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Research and Development Laboratory
Avant Research and Development Team will have capacity and human resource, which work in state-of-the-art laboratories, equipped with the latest process and analytical instrumentation complying GLP.
A dedicated research and development laboratory along with dedicated pilot plant / kilo lab for general production will be installed to meet the demand of high value products. The production capacity will be from 1gm to 10gm.
To make the strengthen and qualified team the company will deploy a good number of human resources from different education background who will have capacity and strength to work in state-of-the-art laboratories, equipped with the latest process and analytical instrumentation complying GLP.
Avant Fine Chemicals Ltd. scientists efficiently conduct rapid process development, optimization of reaction conditions and scale-up of materials, from small-scale high potency compound to large-scale manufacturing.
Our team of professionals will do in:
- Route evaluation and research of scalable new synthetic routes for target molecules
- Patent analysis
- Development of reliable methods for in-process testing and analysis of intermediates and active pharmaceutical ingredients (API)
- Preparation of reference standards
- Development of synthetic organic methods suitable for scaling up Optimization of reaction conditions to reduce cost and maximize throughput by classical methods or statistical design of experiments (DOE)
- Optimization and scale-up of existing routes in jacketed glass reactors to meet the customer´s supply needs.
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Kilo lab Plant
Our low scale manufacturing plant, fully complies with the highest standards of current Good Manufacturing Practices (cGMP).
The main goal of our cGMP Kilo Lab Plant is the synthesis of commercial lots of high-value products up to 5 Kg/batch.
- GLASS, GLASS-LINED, STAINLESS STEEL
- CENTRIFUGES
- FILTERS
- VACUUM DRYERS
- TEMPERATURE: RANGING FROM -20°C TO 180°C
- PRESSURES: FROM DOWN TO 5 MMHG AND UP TO 6 BAR_G
- SEGREGATED HIGH-POTENCY API´S AREAS
- MILLS
- MICRONIZERS
- LAMINAR-FLOW CABINETS
Objective of R&D and Kilo Lab
The main objective of the R&D and Kilo Lab is to establish the highest standard laboratory compliance WHO GLP and ICH Guideline.
The Objectives includes
- Contract development and manufacturing organization (CDMO)
- Contract manufacturing organization (CMO)
- Clinical Trial Batch Manufacturer
- Clinical Trial Product Developer
- Small Scale high value product produced at facility
- Reference standard can be product at facility of different products
- Marinization will be done at the facility
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Scale Up Facility
There will be 1 scale up facility at the site which will be decimated for general molecule from multiple therapeutic class, another one will be kept for further provision.
Production capacity of the plant varied from products to products starting from 50-250kg for.
The multistorey facility will be build applying the ICH, PICs and ISO guideline in different are of the facility starting from construction to HVAC and clean room formation.
All the facility will comply with highest standard compline DGDA, WHO GMP, FDA and the materials produce at the facility will be DMF, CEP grade and approved materials.
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Warehouse
- Warehouse for raw materials and finish product, including sampling and weighing rooms (Class ISO 8)
- Special room for intermediates storage
- Cooling containers
- Weighing room for flammable raw materials
- Bulk storage tanks for solvents
- Refrigerated room for API storage
- Freezers
- ERP fully managed through SAP