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Process Development and Validation Development Services

Process Development and Validation Development Services

Aurigene’s way of phase appropriate process development strategy provides fit-for-purpose chemistry solutions to our clients.

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.

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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

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JUNE 28, 2022

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