Eurofins Advinus has a state-of-the-art manufacturing facility consisting of cGMP pilot plant, intermediate area and ISO class 8 (Class 100,000) clean rooms. It is equipped with excellent infrastructure and reactors ranging from 0.16 KL to 4 KL with cumulative capacity of 50 KL. We assist clients in accelerating scale-up under non-GMP and cGMP compliance.
In addition to supporting early phase programs, including IND-enabling projects, our team assists clients in drug substance supply for clinical trials and commercial manufacturing. We endeavor to be your comprehensive service provider from bench-scale to commercial-scale manufacturing.
- Flexible & Adaptive Manufacturing Suits for Advanced Intermediates and NCEs/APIs
- Fast Track Scale up from Lab to Kilo lab for Preclinical/Tox Studies
- cGMP Manufacturing of Intermediates/NCEs/APIs
- Established technology Transfer Protocol from Pilot to Manufacturing Plant
- Quality & On Time In Full (QOTIF) delivery
- Strategic Outsourcing and backward integration of SM/KRMs as part of Business Continuity Plan
- ZLD (Zero liquid discharge) Effluent Treatment Plant with Mechanical Vapor Recompression
- Spread on an area of 8906 sq. m and built-up area is 7845.43 sq. m
- Reactor Capacities from 20 L to 4000 L with varied material of construction (MoC) Stainless Steel, Glass Lined, all Glass and Halar coated
- Dedicated manufacturing area for handling corrosive reactions like bromination/chlorination etc.
- Four ISO Class 8 clean rooms for isolation of drug substance from gm scale to hundreds of kgs.
- Powder processing area with multi miller, vibro sifter and micronizer in all modules
- Well isolated hydrogenation facility from 0.25KL to 2 KL reactors
- Batch size – 100-200kg (single batch – depending on dilutions)
- Thermic fluid heater, Chilled Water, Chilled Brine, Hot oil and Liquid N2 availability to handle reactions from -78⁰C to +200⁰C
- Fibre glass reinforced plasic (FRP) coated and Halar coated Nutsche Filter.
- Roto Cone Vacuum Driers (RCVD), SS and GL.
- Pilot scale Lyophilizer
- Dedicated storage for Raw Materials, Packing Materials and Rejected Materials
- Walk-in coolers and deepfreezes to store materials at 2 to 8 ⁰C and -20 °C
- Dedicated sampling and dispensing area for raw materials
- Separate area for storing hazardous materials and activated charcoals
- Dedicated finished goods storage area with temperature <25C, 2-8C and -20C