We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including New Chemical Entities (NCE), advanced intermediates, and Key Starting Materials (KSM).
We keep customer's needs at the center of our planning. We understand our customer's requirements at every stage of the journey to the clinic. To meet these varying requirements, we follow a phase-appropriate process development approach. We design our processes based on customer needs. Our interdisciplinary team designs and demonstrates our capabilities in finding sustainable synthetic routes by considering the following concepts:
Reduced number of processing steps Reduced timeline for the scale-up Decreased cost by choosing the most efficient route Reduced chemical or reagent usage and waste production Avoiding expensive or difficult-to-handle raw materials Improved quality and safety profiles
Our execution operations and SOPs are very well designed to internalize the phase-appropriate delivery. Safety, Environment, Legal, Economics, and Control and Throughput (SELECT) principles are a key component of our process development strategy.
We carry out the process development at our state-of-the-art development facilities located in Hyderabad and Bangalore. This facilities are equipped to handle the development of small molecules, peptides, high potent compounds, steroids, carbohydrates and activated mPEGs. The same facility also provides formulation development, analytical method development & validation services and is equipped with a dedicated high potent lab and material generation lab with the capacities of 20L & 50L reactors for API functions.
Early Stage
At an early stage, our focus is to accelerate the journey for the clinic to our customers through science and innovation. Our way of execution and processes ensures agility without compromising on safety, quality and sustainability. The focus at this stage is to ensure faster turnaround time.
Leveraging our vast experience in chemistry & process development, we have a unique advantage of identifying the most important process parameters.
To minimize the risk of failure at the GMP scale, we propose to perform one demonstration batch at our non-GMP kilo lab available at our development facilities.
Late Phase
We have a legacy of developing 500+ molecules, several of which are in the commercial phase in highly regulated markets like the USA, Europe, Japan, etc. We follow a very robust & systematic approach to process development. Our vast manufacturing footprint allows us the flexibility to choose from a variety of unit operations suitable for product manufacturing.
We follow a QbD-based approach for process development and the first step is to identify the key starting material and process parameters that impact the specification of the product. Our supply chain team helps in sourcing the raw materials with desired quality in time. For each stage, we plan a sequence of a well-designed set of experiments (DOE) to understand and establish the sensitivity of important parameters on quality.
We typically run 15-20 experiments per stage to arrive at the most optimum process. Post completion of these studies, three consecutive lab confirmatory batches will be performed to establish the yield & quality of the product.
The processes which are identified to be challenging for scale-up, are studied in our intermediate-scale non-GMP setup at our development facilities, before moving to large-scale manufacturing.
Why Aurigene Pharmaceutical Services?
Phase-appropriate development operations
Legacy of developing 500+ molecules
Horizontal capabilities like polymorph screening, material science, Qbd, PAT tools
Network of multi-scale R and D, NGMP, and GMP manufacturing facilities
Ability to handle various types of chemistry and technology platform
Value added services - regulatory and IP
US FDA approved R and D and manufacturing facilities
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Resources
NOVEMBER 16, 2023
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Biologics Process Development Services
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Gastro Retentive Dosage Form
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Construction of a six-membered fused N-heterocyclic ring via a new 3-component reaction: synthesis of (pyrazolo)pyrimidines/pyridinesw
2012
A conceptually new three-component reaction was developed to construct a six-membered fused N-heterocyclic ring affording (pyrazolo)pyrimidines/pyridines as potential inhibitors of PDE4. The reaction is catalyzed by triflic acid in acetic acid in the presence of aerial oxygen. ...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in 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 formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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