Feb 13, 2020
Pharmaceutical and biopharma manufacturing is expected to reach over $125 billion by 2024. There is no question that the growth is exploding, but how do we grow the industry responsibly and above all, safely.
The ultimate goal for CDMOs (contract development and manufacturing organizations) is to deliver the highest quality and safest product for clients. To ensure total quality control, three elements must be present. First, the biopharma industry must have a high-quality track record of adhering to a strict process and that process must be repeatable. Secondly, the organization must have a clear and focused commitment to leadership and transformative professional development. This will keep the goals clear focused and open to constant assessment. Lastly, the pharmaceutical industry must invest in the most innovative equipment to produce these products safely.
The earlier in the process that quality can be controlled, the better the product will be. Start as far back as the raw materials used. Consider a comprehensive audit of all preferred vendors in order to continue vetting them.
The next step in quality transformation is called process validation. This validation ensures that the manufacturing process repeatable and delivering safe and reliable products. This step also includes effective safety training for all employees to ensure everyone's skills remain up-to-speed. It's important to invest in employees for total quality management.
The pharmaceutical contract development and manufacturing market is expected to reach $126 billion by 2024 with the biologics segment expected to grow at the highest rate as there are more than 50 biologic U.S. patents set to expire in the next five years. It is clear that there is ample room to grow, yet not nearly enough discussion about how to do so responsibly.
During periods of growth, contract development and manufacturing organizations (CDMOs) must take certain precautions to ensure that their top priority continues to be delivering the highest quality products to clients. Three important components to preserving a high-quality track record include strictly adhering to a process, making an unyielding commitment to professional development and acquiring the most efficient equipment.
The earlier in the value stream that CDMOs can control the quality of a material, the better off they will be throughout the entire process. Extending their view of that value stream back to the raw materials received from vendors is the smart approach. Whether it is working with clients to identify preferred vendors or vetting new ones through supplier qualification programs, these comprehensive audits are indispensable to product purity. Regardless of increased throughput, these are critical first steps.
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