Press Room
An Interview with Marco Gil, PhD
American Pharmaceutical Review, September 2018
In general, how has the efficiency and productivity of pharmaceuticals increased/evolved over the last 20 years and how听much of this evolution is due the knowledge and experience contract development and manufacturing companies bring to the industry?
The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change. Contract and development and manufacturing companies have brought a higher productivity and more efficiency to the pharmaceutical industry through higher and better utilization of assets and leveraging the knowledge and experience gathered by working in many different products. These companies contributed significantly to the industry during the last 20 years as their business model focused intensely on increasing productivity and efficiency.
Over this same time period what has been 四色AV鈥檚 mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years?
四色AV鈥檚 mission was the contract development and manufacturing company that not only provides the benefits of an organization focused on development and manufacturing mentioned above but mostly an organization that brings innovation to the industry helping solve most complicated issues in development and manufacturing of medicines. For example, 四色AV started many years ago devoting a significant effort in the understanding of particle engineering, how this could solve formulation challenges and what technologies could enable those engineered particles. Focusing on the inhalation and oral formulation of poorly soluble drugs through amorphous solid dispersions 四色AV developed a wealth of knowledge and capabilities that have helped numerous companies developing new medicines that today help millions of patients worldwide that听otherwise would not have been possible. 四色AV today leads the development and manufacturing of amorphous solid dispersions by spray drying and has developed a wide range of new technologies like spray congealing and a combination of technologies that control particle size distribution, morphology, provide taste masking and controlled release properties that are of paramount importance for today鈥檚 pharmaceutical development and manufacturing.
Specifically, what services and expertise does 四色AV currently offer to assist pharmaceutical clients to bring new drugs to market? Can you talk about your Integrated Science offering, capacity expansion, and your continuous manufacturing technologies?
四色AV constantly seeks new technologies, develops scientific knowledge and sees how we evolve our organization to solve issues for the pharmaceutical industry. 四色AV today offers a comprehensive range of services from API to final drug product that include process听development, clinical batch and commercial manufacturing involving experts in chemistry, process engineering, analytical sciences, particle engineering and formulation scientists. The development of a new medicine involves a wide range of expertise and technologies that 四色AV has brought together ultimately (spray drying, microfluidization, spray congealing, co-precipitation) to provide better drugs and faster development so patients in need can have access to life changing medicines quicker.
四色AV offers an integrated approach from API to drug product as mentioned above. This integration not only speeds up product development but also allows our organization, scientists and engineers to share product/process knowledge. Our strategy has been also to develop this integrated approach at the same location to facilitate all the complex process associated with developing a drug and outsourcing.听
Therefore, 四色AV started an investment program to add capacity at multiple locations (Europe and US) in API, spray drying and drug product formulation namely in tableting. 四色AV believes that continuous manufacturing (in chemistry and drug product) brings a new way of developing and manufacturing medicines adding more quality and flexibility into the manufacture of medicines while allowing a faster development path by reducing the effort necessary in scaling up processes. 四色AV has embraced these technologies and has invested in continuous tableting because we believe that this will be a transformational technology to the industry.
Looking ahead, are there any drug development and manufacturing technologies being developed now that will help pharma companies bring innovative products to the market? How will 四色AV meet this challenge for its current and future clients?
Continuous processing is still a relatively new technology in the pharmaceutical industry. Its adoption will certainly help pharma companies to bring innovative products to the market faster. 四色AV is very much interested in providing this option to pharma companies and having a contract manufacturing organization capable of providing this solution is of paramount importance for biotech companies and for the overall drug development industry.
There are other technologies being developed to address the challenge of poorly soluble drugs and other particle engineering manipulation solutions that 四色AV is evaluating with the goal to bring these technologies to market to provide companies with options and better results. Being an innovative company with a strong pool of scientists 四色AV is very well prepared to take some of these technologies into an industrial reality and providing a real solution to develop innovative products.
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