Situation:

Aurobindo, a multinational pharmaceutical manufacturing company headquartered in India, operates across 15 locations spanning 5 countries, with a focus on pharmaceutical manufacturing and R&D. With a workforce of over 1,560 scientists, Aurobindo boasts in-house expertise in product development areas including API, peptides, custom synthesis, and formulations for oral, injectable/parenteral, and ophthalmic delivery systems. In 2016, Aurobindo embarked on a significant endeavor, establishing a new department dedicated to developing generic inhaled formulations. This move positioned Aurobindo to compete in the competitive generic inhaled formulations market, challenging established brands. However, the venture came with its unique set of challenges. Regulatory hurdles loomed large, requiring Aurobindo to demonstrate bioequivalence, in vitro-in vivo correlation, and navigate complex intellectual property laws and stringent quality standards. Moreover, ensuring therapeutic interchangeability and addressing patient usability added further complexity to the competitive landscape, necessitating speed and cost-effectiveness. Overcoming these obstacles demanded strategic investment in scientific research, regulatory expertise, and market differentiation strategies, all while maintaining stringent regulatory compliance and quality assurance standards.

Challenges:

Prior to SciCord implementation, Aurobindo relied entirely on manual processes, leading to:

1. Increased risk of errors and compromised data integrity.
2. Inefficient paper-based document management, hindering control over document lifecycles.
3. Anticipated influx of new scientists requiring extensive training, posing potential sources of error and non-compliance.
4. Limited scalability of manual systems for growing operations.
5. Crucial need for quality data generation “right the first time,” vital for analyzing clinical material, ensuring stability, and supporting regulatory filings.

Impact:

The successful development and regulatory approval of an inhaled product held significant implications for Aurobindo’s bottom line and the future of the new development group. Implementation of SciCord in 2016 provided several notable impacts:

• Digitized data facilitated easy identification as well as a significantly reduced error rate and preparation time for audits.
• Controlled review and approval of notebooks ensured adherence to defined processes.
• Aurobindo’s subsidiary gained US FDA approval for their generic inhalation suspension (bioequivalent to Pulmicort) since implementing SciCord in 2016.
• Implementation of lab execution processes recorded all required information and markedly reduced training time/resources required for new staff.

The cost of an FDA audit issue can range from tens of thousands to millions of dollars. By implementing SciCord’s solution and improving compliance measures, Aurobindo can avoid or mitigate these costs, resulting in significant cost savings.