At Aurigene, we offer capabilities and expertise for various unit operations applicable to a broad range of APIs. Our vast manufacturing footprint allows us the flexibility to have a variety of unit operations suitable for various types of APIs. We provide most of these unit operations at lab scale as well as in GMP sites and containment facilities. All our manufacturing facilities are equipped with handling major unit operations like reactions, mixing, extraction, distillation, crystallization, filtration and drying. Aurigene has a broad capability of powder processing for API manufacturing. Apart from this, the manufacturing facility has the capability to handle some exclusive unit operations like special drying using ATFD, Spray Dryer for heat sensitive materials, Column Chromatography for advanced purification of racemic mixture, hydrogenation, lyophilization etc.
The various unit operations we serve are:
Spray Drying
Spray drying is a method of producing a dry powder from a liquid by rapidly drying with a hot air. Typically spray drying as an operation is used for thermally sensitive compounds or for obtaining finer particle size distribution or to get an amorphous polymorph.
At Aurigene, we provide spray drying capabilities at the lab as well as manufacturing scale. We have spray dryers up to a maximum evaporation rate of 50 kg/hour in non-potent as well as high potent sites.
Agitated Thin Film Driers (ATFD)
ATFDs are used for converting crystalline to amorphous form. Typically, this operation is used for compounds that are heat sensitive or have less residence time or for the development of an amorphous form of the compound. At Aurigene, we provide ATFD services in lab scale as well as in plant scale. We have ATFDs at a maximum capacity of 3.5 sq. m. We have ATFD operation for regular API as well as high potent APIs.
Micronization
Micronization is the process of reducing the diameter of API particles to enhance the solubility properties of the compound. All manufacturing facilities are equipped with particle size regulating equipment including multi-mill, air jet mill or micronizer, sifter, and blenders. We have micronizers in high potent and steroidal blocks also.
Hydrogenation
Aurigene has broad capabilities for scale-up of different kinds of hydrogenation reactions with different type of catalysts and at wide ranges of pressure ratings. Maximum capacity can be handled in the range of 5KL for the hydrogenator and maximum pressure handles upto 35 bars. The manufacturing sites are also capable of small-scale hydrogenation with a minimum capacity of 20L in the GMP environment.
Cryogenic Reactions
At Aurigene multiple reactors are available at the manufacturing facilities to handle cryogenic reactions. The reactors are ranging from 200 L to 11000 L (3000 Gallon) capacities. Cryo reactors are also available in steroid manufacturing facilities at Aurigene. Both Stainless steel and Haste alloy reactors are available at manufacturing sites.
Reverse-phase High-Performance Liquid Chromatography (RP-HPLC)
Reverse-phase HPLC is the most versatile and efficient method of peptide purification. The working principle is that hydrophobic molecules are retained from the aqueous mobile phase through strong interactions with hydrophobic hydrocarbon ligands. Greater the height of packing, the better the separation of impurities. However, increased column height requires increased amounts of solvents. We have RP-HPLCs in lab scale as well as in plant scale with a capacity ranging from 150 mm diameter to 1000 mm diameter.
Ion Exchange
Ion exchange chromatography separates molecules based on their respective charged groups. It retains analyte molecules on the column based on ionic interactions. The ion exchange chromatography matrix consists of positively and negatively charged ions. In the ion exchange chromatography, some of the impurities will get absorbed and the compound with enriched purity will come in the form of a solution. We have ion exchange chromatography on lab scale as well as production scale with a capacity of 350 mm diameter.
Lyophilization
As a part of peptide molecule development and manufacturing, both manual and auto peptide synthesizers are available which can accommodate multiple scale of peptide compounds. This is supported by multiple capacity of Ion exchange columns and RP HPLC columns as a part of the purification technique. Finally, the material is lyophilized to get the final compound. All these unit operations can be carried out in both development and manufacturing area. From the lab 20 to 50 g of non GMP material can be provided to the clients and 100 to multi kilos can be supplied to customer with various batch sizes.
Why Aurigene Pharmaceutical Services?
Variety of unit operations in lab and plant scale
Experts scientists, process, and lead engineers
QbD-based process design
Flexible scale of operations
Unit operations in containment
Other Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Contact Us
Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...
Read More
Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...
Read More
Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
Read MoreAlternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2023
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-
Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2021
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 -
Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2021
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
Read More -
Simple and efficient synthesis of imidazoquinoxalines and spiroquinoxalinones via pictect-spengler reaction using Wang resin, Synthetic Communications
2021
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...
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.