Dhakshnamoorthy Vellingiri

• Managed the formulation and development of 2 oral solid and 3 parenteral dosage forms, addressing varying complexities to facilitate efficient laboratory testing and clinical trial initiation.
• Streamlined formulation processes and successfully transferred technology from lab scale to clinical scale for two distinct sterile formulation programs.
• Executed root cause analysis and implemented mitigation strategies for critical process issues in two oral solid formulations.
• Executed routine maintenance and management of oral solid lab equipment, enhancing operational efficiency.

• Designed and launched six new solid oral formulations to enhance product offerings in APAC, featuring various dosage formats such as IR/SR tablets, SR pellets, sachet granules, center-filled gummies, micro-effervescent tablets, and fizzy probiotics.
• Spearheaded development of two large-scale personalized nutrition products through collaborative model with South Korean CMO, encompassing 19 oral solid formulations.
• Assisted in mapping proactive risk analysis processes to identify potential gaps. Supported the design of experiments to evaluate risk mitigation strategies. Contributed to the scoring and analysis of risk factors to enhance project outcomes.

Directed formulation development of solid oral dosage forms, leading a team of three members.

• Established new OSD lab and pilot facility, ensuring operational readiness.
• Executed development of four complex generic products for USFDA approval, including controlled release tablets utilizing osmotic coating. Assisted in formulation of immediate release tablets through roller compaction for BCS IV molecules.
• Supported creation of immediate release pellets in capsules for Class IV molecules using ball milling and Wurster layering processes.
• Contributed to formulation of delayed release pellets in capsules via Wurster coating process.

Achieved enhanced product quality and compliance through the development of over 8 oral solid formulations. Streamlined formulation processes by leveraging insights to establish best practices. Contributed to team initiatives focused on knowledge sharing and ongoing improvement efforts.

• Developed sustained-release matrix tablet for BCS Class IV molecules utilizing innovative hot melt granulation techniques for Class II molecules.
• Engineered immediate-release tablets through direct compression techniques for highly oxidative active pharmaceutical ingredients.
• Applied Wurster coating techniques to formulate and optimize drug pellets, significantly enhancing stability and performance of hygroscopic and oxidative compounds.

Assisted in establishing a new potent and anti-cancer lab and pilot facility for Biocon. Supported teams in achieving key milestones and learning objectives. Contributed to the development of innovative research protocols.

• Engineered low-dose immunosuppressant tablet formulation for highly unstable semi-synthetic molecule utilizing organic top spray granulation techniques.
• Executed development of high-dose fixed combination products to align with patent non-infringement objectives.
• Formulated and optimized tablet for oral suspension, enhancing bioavailability of BCS Class IV compound.

Engineered and optimized over 8 oral solid dosage forms, ensuring compliance with US FDA and EMA regulations.

Some of the technical challenges and key learnings includes:

• Executed formulation strategies for two para IV products, ensuring adherence to USFDA and EMEA guidelines through innovative patent invalidation double granulation techniques.
• Developed innovative dry powder for oral suspension to enhance taste masking of bitter cephalosporin antibiotic through hot melt granulation.
• Developed formulations for DR pellets and tablets targeting highly unstable proton pump inhibitor molecules.
• Engineered 505 (b)2 injection formulation transforming dry powder into oral suspension while addressing taste masking challenges for a 3rd generation cephalosporin molecule.