Seven Observations that Can Help Keep Operations Running Smoothly During the Pandemic
COVID-19 continues to take a toll at home and in business. As companies everywhere work to adjust to a new way of working, those of us in the Contract Development & Manufacturing Organization (CDMO) world may have an advantage. As essential work, many of us have maintained ongoing on-site operations, and as chemical manufacturers, we have always been committed to strict cleaning guidelines.
Nevertheless, to remain open, and for the safety of employees, we’ve had to rethink basic processes – from handwashing and wearing face masks beyond the GMP suite, to eating in the cafeteria and holding client meetings. New protocols and Standard Operating Procedures (SOPs) will continue to unfold as we adjust to the new working normal, but below are a few observations and lessons learned that can help us make the adjustment just a little easier.
- Employees remain the lifeblood. Chemists, project managers, QA teams, admin staff and all employees remain the lifeblood to the success of a CDMO. These are unprecedented times and not only do we need to make sure employees stay home if they are experiencing any symptoms, but we also need to be empathetic to their concerns and situations. For any employees working remotely, it’s critical to maintain ongoing communication and collaboration and reinforce the valuable role they provide.
- It’s easier than ever to connect with sponsors. In API manufacturing, it’s vital that CDMOs connect with their sponsors, maintaining regular update meetings and collaborating when issues arise. Surprisingly, getting in touch with sponsors is now easier than ever. Many sponsors are working from home offices and video calls or even the old-fashioned phone call can get a lot accomplished in a short amount of time, without the hassle of trying to coordinate schedules for in-person meetings.
- The decline in on-site visits requires ingenuity. While ongoing communication with sponsors has improved, unfortunately on-site visits from potential new sponsors has declined because of travel bans and stay-at-home guidance. Before COVID-19, prospective sponsors required facility audits to make sure CDMOs had the capabilities, equipment and people needed to handle their projects. Today, CDMOs need to create new ways to attract new sponsors, through videos, virtual reality and other technologies that can help sponsors experience the site virtually.
- Cleanrooms have taken on new meaning. Cleanrooms designed to remove pollutants, particles and contaminants in GMP manufacturing have always been a way of life. Here at Seqens NA, there are three things that we are diligent about maintaining in order to ensure cleanrooms: control and quality of the air, internal surfaces, and equipment. We have strict, validated protocols in place for cleaning GMP suites in between each project; we conduct regular monitoring and testing and we’re recertified annually. Cleanroom staff are specifically trained for these environments and they wear protective clothing designed to trap contaminants that are naturally generated by skin and the body. This expertise and understanding of viral transfer can be applied across the organization and help inform protocols for where people congregate, how surfaces are cleaned and what protective equipment may be needed – beyond the GMP suite or cleanroom.
- Sticking to a schedule is more important than ever. In times of fear, uncertainty and change, sometimes sticking to regular routines and schedules can be a welcome distraction. This fact makes a CDMO’s environment quite welcoming when it comes to a pandemic. CDMOs live by SOPs, protocols and strict project schedules and maintaining these rigorous routines just may be the key to keeping business moving full steam ahead.
- Pandemic shines a spotlight on our overreliance on overseas supply chains. Due to travel bans, border closures, and shelter-in-place measures that are being enforced around the world, it has become glaringly evident that our reliance on China and India for drug products, APIs and raw materials is bordering on the dangerous. In fact, it’s estimated that pharmaceutical companies in India “supply about 40-to-50 percent of all U.S. generic drugs.” Perhaps the pandemic will be the catalyst to government and private action to bring manufacturing back to the U.S.
- Pivoting may be a new protocol to success. While API manufacturing continues to be in high demand as sponsors look to bring vital drugs to market, there are other ways that CDMOs can lend their expertise to assist in responding to the pandemic. For example, understanding that businesses have been challenged with getting supplies of hand sanitizer to employees because of supply chain disruption and a shortage of the raw material Isopropyl Alcohol (IPA), Seqens got to work manufacturing hand sanitizer. We followed the chemical formula recommended for hand antisepsis against coronavirus, by the World Health Organization (WHO).
The coronavirus is creating mayhem across the world, but the silver lining is that many CDMOs are realizing just how resilient they can be when faced with adversity. Sticking to best practices that have always been the hallmark of CDMOs, focusing on employees and customer communication and being willing to change course as needed, will be the keys to success and continued innovation that bring critical drugs to market.
Author Biography
Ed Price is President and CEO of Seqens North America (formerly PCI Synthesis), an integrated global provider of pharmaceutical synthesis and specialty ingredients. From the company’s Newburyport, Mass. operations, Seqens N.A. provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules.