Process Development & Scale-Up at o2h Discovery
At o2h Discovery, our Process Research & Development (PR&D) and Scale-Up teams help transform promising laboratory routes into safe, robust and development-ready processes. From early route assessment through process optimization, safety evaluation and kilogram-scale synthesis, o2h Discovery helps transform laboratory chemistry into robust, reproducible and scale-ready processes.
Our scientists support projects from route scouting and process optimization through analytical development, process-safety assessment, scale-up synthesis and technology transfer, enabling efficient progression from milligram- and gram-scale chemistry to kilogram-scale non-GMP production.
By integrating synthetic chemistry, analytical sciences, purification, process safety and scale-up capabilities, we focus on improving process reproducibility, impurity control, yield, operational simplicity and scale readiness while maintaining the required product quality.
Our Process Development Capabilities
From route selection to scale-up readiness - an integrated set of scientific capabilities for a robust , scalable process.
Route & Process Development
Build the right process
Route Scouting & Route Evaluation
Assess existing and alternative routes to identify practical, scalable and cost-efficient approaches.
Analytical Method Development & Process Monitoring
Develop fit-for-purpose methods for reaction monitoring, optimization, and material characterization.
Reaction & Process Optimization
Optimize reagents, stoichiometry, solvent, temperature, time and sequence to improve robustness, reproducibility and yield.
Isolation & Product Quality
Improve purity and reproducibility
Impurity Profiling & Control
Identify, monitor and control process-related impurities and study their formation, fate and purge.
Work-Up, Isolation & Purification Development
Develop scalable work-up and isolation strategies to minimize or eliminate chromatographic purification.
Salt Screening & Crystallization Development - Where Applicable
Optimize salt forms and crystallization conditions to control solid-state properties and stability.
Scale-Up & Risk Management
Enable safe and scalable execution
Process Safety Assessment
Progressive evaluation of thermal and operational hazards to establish safe process controls.
Stability & Stress Evaluation - Where Required
Evaluate stability and stress behavior of intermediates and final materials to support decisions.
Scale-Up & Technology Transfer
Demonstrate the optimized process at increasing scale and transfer with complete documentation.
Our Scale-Up Solutions
Kilo-Lab Infrastructure
Dedicated infrastructure for controlled reaction execution from laboratory to kilogram scale
- Jacketed glass reactors across multiple volumes
- Controlled heating and cooling with integrated temperature-control systems
- Filtration and solid-isolationAppropriate batchand delivery equipment
- Vacuum drying capabilities
Non-GMP Scale-Up
Gram-to-multikilogram non-GMP synthesis of intermediates, APIs and specialized building blocks
- Support for discovery and development programmes
- Analytical testing and process monitoring throughout scale-up
- Appropriate batch documentation and technical reporting
GMP Manufacturing Support
End-to-end project coordination and technical oversight through qualified manufacturing partners
- Partner qualification, scope definition and execution planning
- Real-time communication throughout manufacturing and delivery
- Single point of technical and project accountability
Our Process Development Lifecycle
A proven, integrated approach that transforms laboratory chemistry into robust, scale-ready processes.
Our Process Safety
Process safety is integrated into our development and scale-up approach to help identify potential hazards before larger-scale execution.
DSC
Thermal behavior and decomposition risk, guide reaction design and scale-up controls
TSU
Early thermal screening of materials
Advanced Assessment
Yoshida correlations, fall-hammer impact testing, reaction calorimetry & more
Improving Regioselectivity and Process Efficiency for Kilogram-Scale Delivery
A client approached us to improve the synthesis of a key heteroaromatic intermediate required for late-stage discovery programmes. The existing procedure generated approximately a 1:1 mixture of regioisomers, resulting in difficult purification and an overall yield below 15%, making the route unsuitable for efficient multigram or kilogram-scale preparation.
Process Challenge
The first key transformation showed poor regioselectivity, generating closely related isomers that were difficult to separate.
Material losses during downstream purification further reduced overall process efficiency.
o2h Approach
The PR&D team performed a detailed route and mechanistic assessment and identified an alternative reacton sequence
designed to address regioisomer formation at its source.
Following laboratory experimentation, the team optimized reaction conditions, solvent system, temperature control,
downstream reduction and work-up to improve selectivity, reproducibility and isolation.
Outcome
The optimized process reduced the major regioisomer impurity from approximately 50% to around 5% in the key transformation.
The revised three-step sequence achieved >94% crude yield in the first step, approximately 45% yield in the coupling step and approximately 78% yield in the reduction, with the final amine obtained at >97% HPLC purity.
The process was successfully demonstrated at scale, with more than 0.5 kg delivered in a single batch.
By addressing the fundamental selectivity issue and simplifying downstream processing, the optimized process delivered a greater than three-fold improvement in overall yield and established a more robust and scalable route.
Our Team
Sunil Shah
CEO - o2h Ventures and Co-founder - o2h discovery
Sunil's Biography
Sunil Shah
CEO - o2h Ventures and Co-founder - o2h discovery
A serial entrepreneur having begun a career in the Life Sciences team at PA Consulting group followed by co-founding two companies in the information technology and life sciences sector. The second of these companies, Oxygen Healthcare Ltd was acquired by Piramal Enterprises Ltd (BSE: PEL). Sunil co-founded o2h ventures which involves discovery services / collaborations, seeding drug discovery, academic in-licensing and biotechnology incubation. Sunil has a degree in Biochemistry and an MBA from Cambridge University
Prashant Shah
CEO - o2h co-work labs and co-founder - o2h group
Prashant's Biography
Prashant Shah
CEO - o2h co-work labs and co-founder - o2h group
A serial entrepreneur having begun a career with the Strategy group of at Accenture followed by co-founding two companies in the technology and life sciences sector. The second of these companies focused on drug discovery was acquired by a public company. Prashant co-founded o2h Ventures which is involved in seeding, incubating and investing in early stage life science and technology companies. Prashant has a BEng, MSc and an MPhil in Management.
Hemal Soni
Vice President - Chemistry
Hemal's Biography
Hemal Soni
Vice President - Chemistry
Hemal has comprehensive experience in leading & guiding multi-FTE synthetic chemistry research and development collaborations which are in support of the fast-paced drug discovery programs. At o2h discovery, he oversees the progress and troubleshooting of all the ongoing projects and helps with evaluation as well as kick start of new programs. Hemal obtained his Ph.D. in organic chemistry from Kadi Sarva University, Gujarat. He has >17 years of industrial experience. Prior to joining o2h discovery, Hemal worked with Piramal Discovery Solutions (PDS) for 4 years during which he led the largest project covering 42 FTEs for a UK-based collaborator. He has worked with clients all around the world including UK, USA, Japan, Australia, Singapore and more.
Nilesh Dagia
Chief Special Projects Officer
Nilesh's Biography
Nilesh Dagia
Chief Special Projects Officer
Nilesh leads the global operations of o2h group covering a wide range of innovation led investment, life-science and technology businesses. He is also overseeing the development and execution of the new o2h discovery Shirish Research Centre in Ahmedabad, India. Prior to joining o2h group, Nilesh worked with Piramal Group in various capacities including as an Alliance Manager for a risk-share oncology-based collaboration with a US Big Pharma and has also worked as the Head of Biology in Piramal Discovery solutions. Nilesh obtained his Ph.D. from Ohio University and completed a post-doc in Immunology, Stem Cells and Regenerative Medicine at Harvard Medical School. He is the author and inventor of >30 life science patents and publications. He received the Young Scientist of India award from OPPI in 2010.
Frequently Asked Questions
What is Process Research & Development?
Process Research & Development converts laboratory chemistry into a safe, reproducible and scalable process suitable for larger-scale execution. Activities can include route evaluation, reaction and work-up optimization, impurity control, analytical development, process-safety assessment and scale-up demonstration.
What Process R&D and Scale-Up services does o2h Discovery provide?
o2h Discovery provides integrated support covering route scouting, process optimization, work-up and isolation development, analytical method development, impurity profiling, crystallization, process-safety assessment, kilogram-scale non-GMP synthesis and technology transfer.
What scale of chemistry can o2h Discovery support?
Projects can progress from milligram- and gram-scale laboratory development through kilogram-scale non-GMP synthesis using dedicated process-development and kilo-lab infrastructure. The appropriate scale-up pathway is defined based on chemistry, process safety, equipment fit and project requirements.
How does o2h Discovery manage process safety during scale-up?
Process safety is considered throughout development rather than only immediately before scale-up. Depending on the process and identified risks, assessment may include DSC, TSU, structured risk assessment, Yoshida evaluation, impact-sensitivity testing and reaction calorimetry.
Can o2h Discovery support projects through GMP manufacture?
Yes. Where GMP manufacturing is required, o2h supports technology transfer and execution through qualified manufacturing partners while retaining end-to-end ownership and accountability for project coordination and delivery. Our team qualifies the appropriate GMP partner, defines the technical scope and execution plan, aligns the proposed approach with the client, and coordinates activities through manufacture and delivery. o2h scientists and project leaders remain actively involved throughout execution, including on-site technical oversight at the partner facility where appropriate, while maintaining timely technical communication and project updates with the client. This integrated model provides the client with a single point of technical and project accountability, while leveraging qualified GMP manufacturing infrastructure for progression into clinical and later-stage development.
What documentation is provided following process development or scale-up?
Depending on project scope, deliverables can include optimized experimental procedures, analytical data, process observations, impurity information, safety assessments, batch documentation, scale-up reports and technology-transfer information.
Ready to take your chemistry to the next scale?
Discuss your process development or scale-up requirements with our scientists.
