Why Early Process Development Saves Time and Cost in Drug Manufacturing
In the World of Pharma, Time is Everything
When developing a new drug, many companies focus first on discovery and clinical trials — but often leave process development until much later. This can lead to unexpected challenges, delays, and higher costs during scale-up or regulatory filing.
What is Process Development?
Process development is about finding the most efficient, safe, and reproducible way to manufacture a drug substance — from small lab batches to large commercial production. It involves selecting the right synthetic route, optimizing reaction conditions, and identifying impurities early.
Why Start Early?
- Avoid Costly Rework: Identifying and controlling impurities early prevents surprises during regulatory review.
- Faster Tech Transfer: A well-defined process makes it easier to scale up from grams to kilograms without troubleshooting later
- Regulatory Confidence: Consistent and validated processes mean fewer queries from regulatory agencies.
- Sustainability: Early optimization can reduce solvent use, waste generation, and energy consumption.
Anugraha Lifescience's Approach
At Anugraha Lifescience, we work closely with partners to start process development as soon as a promising lead candidate is identified. Our R&D and analytical teams collaborate to ensure robust, scalable, and cost-effective manufacturing routes — from mg-level synthesis to commercial production.
Bottom line: Early process development isn’t just a technical step — it’s a business advantage. By investing in it early, you save time, reduce costs, and bring life-saving medicines to market faster.