Working Through the COVID-19 Crisis in API Manufacturing

4 measures CDMOs can take to keep staff safe and operations running smoothly

Posted: April 14, 2020

API Manufacturing and Pharmaceutical Manufacturing

Even for those of us in the life sciences industry who have studied pandemics, disease and other medical conditions and work each day to create the critical ingredients that can go into medicines that prevent or treat them, the situation that COVID-19 has caused around the world could never have been imagined. 

Here at Seqens North America, our work manufacturing drug ingredients is considered essential by the government, so we are in full operating mode with business as usual, yet in very unusual times.  In fact, Seqens North America as well as our teammates across Europe, have been quite busy working on drug ingredients for anti-virals and other medications, as well as hydroalcoholic solutions targeted at coronavirus.

As we go about business, we’ve put essential protocols in place, requiring any employee feeling sick to stay home and we’ve instituted strict hand-washing policies, social distancing of six-feet and other steps to keep our staff safe.  

Given the fluidity of the pandemic, we’re committed to being flexible and agile and taking the situation week-by-week, and we’ll adapt whenever and however we need to.  The safety of our employees is of paramount concern.

The good news is that, given the meticulousness necessitated by our manufacturing processes, we always follow best practices to avoid contaminating the substances we manufacture.

Below are four measures CDMOs can take to keep staff safe and operations running smoothly:

  1. Lessons from the cleanroom can be applied across the organization. Keeping all areas as sterile as possible is key. Committing to a regimen of scheduled disinfecting of all areas – especially common areas – is now a business necessity that may become the business norm.
  2.  Keeping lines of communication open is essential. More frequent communication with sponsors, suppliers and employees can’t be stressed enough. Regular sponsor update meetings should be conducted (albeit virtually) to address any concerns or challenges.  Likewise, there should be open lines of communication between employees and management to quickly address any concerns.
  3. Now is the time to loosen up vacation and sick leave policies. It’s important to be flexible with workers when it comes to sick leave policies and paid vacation time so they can take care of family first without fear of lost income.
  4. Keep schedules as normal as possible.  In times of fear, uncertainty and change, sometimes sticking to regular routines and schedules can be a welcome distraction.  Here are Seqens, while we’re sensitive to the situation unfolding, we’re trying to keep things as normal as possible.   

Situation Shines a Spotlight on Supply Chain Reliance Overseas

While we continue to deliver the critical APIs our customers rely upon and there has been no slow-down in our operations, the coronavirus situation has spotlighted another serious concern across the industry – ensuring we can continue to receive critical raw materials produced in China and India. 

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 huge. In this time of crisis, the U.S. may not to be able to import drug substances or drug products into the U.S. causing serious shortages for U.S. consumers and potentially dire health consequences.

It’s been reported that China exports 97 percent of all antibiotics and 80 percent of active ingredients used to make drugs in America.  Just when we need drug products to battle not only the coronavirus pandemic, but also heart disease, diabetes, cancer and other illnesses, we’re confronted with the possibilities of shortages because of the effects of coronavirus on China.

TECH TRANSFER

In fact, the FDA recently said in a Vox article that, “since January, it has communicated with more than 180 drug manufacturers about potential disruptions because of the coronavirus and identified 20 drugs that might be vulnerable,” since they source from China.  In addition, it’s estimated that pharmaceutical companies in India “supply about 40-to-50 percent of all U.S. generic drugs.”   

If anything, perhaps the current crisis will be the catalyst to government and private action to bring manufacturing back to the U.S. Recently, legislation was introduced that would require drug makers to more clearly disclose the origin of ingredients and the amount of stock on hand. It’s also promoting policies that would require government to make the purchase of U.S.-made drugs and medical supplies a priority over those manufactured elsewhere. This is a good start, but much more needs to be done.

The coronavirus pandemic is unprecedented, unnerving and creating mayhem across the world, but by being steadfast in moving forward with API manufacturing and delivering the essential drug products and breakthrough solutions that have always been the hallmark of American ingenuity, we’ll come out on the other side.

About the Author

Ed Price CEO of PCI Synthesis
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...

Do you have questions? Talk to Ed.