In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
In pharmaceutical industry, preparation of dosage form needs scale up in/at several stages. For instance, a typical small scale laboratory development of Oral Solids involves a 0.5-2kg batch which can be scaled up to 5-10 kg and then to 20-100 kg on a pilot scale. Typically, production scale ranges from 200-1000kg. Technology transfer involves manufacturing drug product with increasing batch sizes on larger equipment or using continuous processing on pilot scale equipment.
Technology Transfer Process:
Factors Influencing Technology Transfer
Drivers for Technology Transfer –
- Multinational pharmaceutical companies transfer technology to local manufacturers to fulfill contingency supplies.
- To gain access to new machinery, training, know-how and business partnership.
- Exclusive capabilities at multiple sites within an organization can be utilized.
- To gain access to good business and manufacturing practices in the areas of product identification and formulation technology.
- Balance cost to develop potential for competitive pricing.
- Vertical Integration, for higher capacity utilization and lower production costs.
- Strong economy, political stability and supportive regulatory, business & scientific environment.
- Meeting regulatory requirements of different markets across the globe.
Barriers of Technology Transfer –
- Lack of efficiency due to absence of automation leading to higher costs.
- Incapability of local producers to meet International Quality Standards and gain market share.
- Cost of prequalification at International level.
- High labor turnover and absenteeism due to unattractive conditions of service
- Ineffective coordination or compatibility between the sending and receiving sites or between development and manufacturing units initially.
Leveraging Piramal’s Global Network for tech transfers
Piramal utilizes its Global network to provide end to end services in Oral Solids and Sterile. Our development units are located at Ahmedabad, India and Morpeth, UK. Commercial manufacturing of Oral solids is offered through our FDA Approved sites at Morpeth and Pithampur.
Global Footprint – Tech Transfer Capabilities