Crystallization Strategies for API Development and Scale-Up
About this webinar
Crystallization is a vital step in the development and production of small molecule active pharmaceutical ingredients (APIs), playing a pivotal role in defining the purity, stability and manufacturability of APIs.
It has a direct influence on key quality aspects, including purity, polymorphic form, particle size distribution and downstream processability.
This webinar will cover the scientific and engineering principles that regulate crystallization, such as nucleation kinetics, supersaturation control and solid form selection.
Attendees will learn about the strategic selection of solvents, the development of strong crystallization techniques and the challenges of scaling up from lab to plant.
The featured speakers will cover critical tools and methods for monitoring and controlling crystallization, such as Process Analytical Technology (PAT), as well as how to apply Quality by Design (QbD) principles to maintain consistency and regulatory compliance.
This webinar will provide a thorough knowledge of how crystallization decisions made at the bench can affect downstream operations, cost and time to market using real-world case studies and practical examples.
Register for this webinar to learn how crystallization strategies can optimize API development and scale-up.
Who should attend
- Process Development
- Chemical Development and Manufacturing
- Analytical & Solid State Characterization
- Quality & Regulatory
What you will learn
- The importance of crystallization in API development and manufacturing
- Strategies for solid form selection and control
- Scale-up challenges and solutions
- The role of PAT and QbD in crystallization process design
- Case studies from development to commercial scale
Featured Speakers
Jayadeva Sajankila
Jayadeva brings over 26 years of industry experience in Process R&D, Technology Transfer, Commercialization and Business Operations. He has a strong track record in small molecule development, manufacturing and driving strategic growth through digital transformation and operational excellence.
Before joining Aragen, Jayadeva was the Head of Key Account Management, Development Services at Syngene International Limited.
Nilesh C Hastak, SSBB
With over 20 years of experience in particle science and engineering, Nilesh specializes in the development and optimization of crystallization processes, solid form screening and particle design for small molecule APIs. His expertise spans the full lifecycle of pharmaceutical development, from early-stage solid form selection to commercial-scale manufacturing. As a certified Six Sigma Black Belt, Nilesh applies data-driven methodologies and statistical tools to enhance process robustness, reduce variability and drive continuous improvement. His work integrates Quality by Design (QbD), Process Analytical Technology (PAT) and advanced crystallization engineering to deliver scalable, compliant and cost-effective solutions.
Partner for this event
Aragen Life Sciences
Aragen Life Sciences is a leading R&D and manufacturing solutions provider for the life sciences industries worldwide. It offers end to end integrated and standalone solutions for small molecules and biologics from early discovery to commercial manufacturing. Established in 2001, the Company operates through a network of sites located globally with a team of 4500+ scientists and 450+ PhDs. Its expertise and experience have enabled over 400 customers to advance their research programs from discovery through commercialization. Aragen’s innovative mindset, infrastructure, flexible business models have enabled us to serve large pharma, biotech, agrochemical, animal health and performance chemical industries globally. Visit www.aragen.com for more details.
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