We have one of the largest capacities in the world to manufacture highly potent compounds with Occupational Exposure Limit (OEL) in the range of 0.1-1 μg/m3 (OEB 5). Our facilities are audited by US FDA and regulatory bodies.
We offer manufacturing of high potent compounds supported by special unit operations like micronization and spray drying. Our facility is designed to give output as low as 100 gm to multi-tons.
Our approach for high potent handling 
Overview of our High Potent Sites and Features:
We provide high potent API manufacturing services from 3 sites based out of India. All sites are inspected by US FDA and other reputed regulatory bodies. Some of the key features of sites are as listed below:
- Multipurpose facility with various sized reactors
- Isolator technology in place for containment to handle OEB 5 compounds
- Hastelloy ANFD with isolators
- Facility for milling, blending and packing under isolation techniques with isolators
- Analytical instruments (HPLCs, GC, FTIR, UV-Vis, polarimeter and microbiology laboratory)
- Cleaning-in-place (CIP) practiced under the closed condition
- Separate effluent detoxification reactor
Material Handling
We take utmost care in handling highly potent materials at every stage of the manufacturing journey.
- cGMP compliant isolator systems (OEL 0.1µg/m³) for highly potent raw materials, intermediates dispensing, charging, filtration and drying, and packaging
- Reaction mass transfer through closed loop lines
- Rapid transfer ports for solid material transfer
- Dedicated warehousing: The warehouse is specially designed for handling high potent raw materials in both solid and liquid forms. A SAP-integrated barcode system logs proper storage
HVAC and Utilities
- HVAC system with zone classification to avoid cross-contamination
- Differential pressure system with temperature and humidity control
- HEPA filtered air
- Multiple utilities (cooling tower water, hot water, chilled brine, nitrogen, compressed air and steam)
Production Blocks and Unit Operations
The manufacturing process starts with reaction, sampling, workup, and isolation, followed by filtration and drying operations. The facility also has special unit operations across all the modules ranging from material removal into the canister, layer separation, drying, rotation evaporator, spray drying, and micronization. All modules have ANFD and micronizers in SS packing isolators.
Dedicated QC
All the analysis steps, such as in-process, intermediate, and complete, are performed in a dedicated QC lab designed to handle high potent molecules. The QC lab is equipped with a weighing and sample preparation isolator. The samples are analyzed using various equipment such as HPLC or GC. The QC lab relates to Empower 3 servers and all the data related to in-process, intermediate, and complete analysis steps are transferred to SAP through LIMS software.
Detoxification
Our manufacturing processes follow not only the highest quality but also sustainability standards to protect the environment and our workforce. The effluents are treated and processed in detoxifying areas, as per regulatory standards.
Why Aurigene Pharmaceutical Services?
One of the largest capacities in Asia- 3 US FDA inspected cytotoxic GMP facilities
Variety of unit operations in containment
Highest standards of safety
Experience in manufacturing 50+ high potent compounds
Dedicated high potent R&D facility allowing for faster development and technology transfer
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Resources
JANUARY 04, 2021
The influence of formulation development and its route of administration
Physicochemical properties of drug forecast its ADME chance, however, the formulation development strategy or dosage form is decided based on the bioavailability, commencement and duration of therapeutic response. An ideal strategy for formulation development should consider the dose of the drug, intended route of administration, anatomical and physiological barr...
Read More
Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
Read More
Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
Read More
Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation
2008
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...
Read More-
Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
Read More -
A Sensitive and a Simple RP-HPLC Method Development and Verification for the Quantitative Estimation of Cholecalciferolin Tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E)- 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formul...
Read More -
Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
Read More
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market