CMOs Gain Speed Through Digitization

Only a year ago, research examined the impact of COVID-19 on trends in biopharmaceutical industry and bioprocessing and found that “use of contract manufacturing organizations (CMOs) and other outsourcing will continue to accelerate.” ⁽¹⁾

More than 12 months later, this prediction is proving to be accurate.

CMOs and contract development manufacturing organizations (CDMOs) play a central role in making COVID-19 vaccines available throughout the globe, and this work coincides with meeting the rising demands in personalized medicine.

“Manufacturing capacity for cell and gene therapies was already strained before the pandemic, and now it’s under further pressure because vaccines use a lot of the same technology,” explained Peter Shapiro, senior director of drugs and business fundamentals at GlobalData. He went on to note, “…vaccines are understandably being given priority for product slots over cell and gene therapies. So, increasing capacity is very important.” ⁽²⁾

Shift Into High Gear

In an industry that already has the accelerator to the floor, digitization makes it possible to pick up speed. Not only does it allow for faster production, but it helps scale quickly and build greater capacity. The manufacturing industry as a whole recognizes that digitization is necessary for shifting into high gear. A March 2021 survey found that as a result of COVID-19, manufacturing leaders have identified digital transformation as a business imperative:

• 91% reported an increased investment in digital transformation.
• 77% of respondents reporting an increased investment in digital transformation characterized it as a significant or dramatic investment.
• 95% agree that digital transformation of manufacturing is essential to their company’s future success. ⁽³⁾

For CMOs and CDMOs in personalized medicine, adopting new technology has the added benefit of lowering the expenses associated with creating small or individual batches. A recent article in Forbes confirmed, “Customizing products during manufacturing becomes easier for factories with increased automation…it produces a highly personalized product at a reasonable cost.” ⁽⁴⁾

Keep Your Hand on the Wheel

Digitization makes it possible for manufacturing to happen more quickly, but speed is only an advantage if you can accelerate while maintaining or improving quality at the same rate.

Quality is enhanced through digitization in numerous ways:

• Human errors caused by manual paper-based processes are eliminated.
• Data entry errors can be corrected in real time, which ensures these errors don’t travel through the production process and cause delays.
• Information travels between connected systems, which ensures data integrity.

As an example, global pharmaceutical compounding company Fagron faced an unexpected surge in demand when Dexamethasone was found to reduce deaths in critically ill COVID-19 patients ⁽⁵⁾. Digitization enabled Fagron to achieve a new level of productivity while maintaining quality throughout the product’s life cycle, and their team in North America is approaching their goal of 95% right-first-time output.

Conclusion

The early prediction that COVID-19 would increase and hasten the demand for contract manufacturers has proven to be true. In the same study, 70% of biopharmaceutical company executives indicated they believe this trend will accelerate in the long term. ⁽⁶⁾ To keep up in the industry and deliver the quality that’s expected, digitization is critical. With the world turning to contract manufacturers, expectations are high.

“We are in a very good position in terms of public awareness and it is our role, as the sector that is helping manufacture the drugs and vaccines that are going to get us through COVID, to live up to that responsibility,” said Gil Roth, founder and president of Pharma & Biopharma Outsourcing Association (PBOA).

Resources:

1. COVID-19 Impact on Bioprocessing: Accelerating Trends and Long-term Impact of Novel Coronavirus-19 on Biomanufacturing and Bioprocess Supply Chain, Ronald A. Rader, Eric S. Langer, Dr. Kamna Jhamb, BioPlan Associates Inc., June 2020.
2. U.S. Pharma Market 2022 and Beyond, CPhI, June 24, 2021.
3. 2021 State of Manufacturing: Digital Transformation Is The Key to Winning In The “Next Normal,” Dave Evans, Forbes, May 3, 2021.
4. Digitization Drives Opportunities And Challenges For Transformation, Maher Matta, Forbes, June 4, 2021.
5. FDA Adds Dexamethasone to COVID-19 Temporary Compounding Lists, FDA News, July 16, 2020
6. Supra note 1.
7. United States Pharmaceuticals and Biopharmaceuticals 2021, Global Business Reports, May 17, 2021.