At APSL, 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. APSL 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 APSL, 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 APSL, 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
APSL 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 APSL 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 APSL. 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 Special Unit Operations 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
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