COVID-19 Vaccine Ultimate Challenge

On how consultants can help to tackle the biggest manufacturing challenges in preparation for commercial release.

The life-sciences field knew the potential threat posed by the COVID-19 since the beginning, based on historical outbreak data from similar viruses and the initial information on the level of “R0” (basic reproduction number which measures the intensity of an infectious disease). Few could have predicted the extent of global health and economic impact that this new virus would entail. The cost of lives has been catastrophic and preserving life is what really matters now. To provide some perspective, at the moment I’m writing this article there were 17,051,224 confirmed cases throughout the world and tragically, there were approximately 666,430 deaths. These numbers keep on the rise, as the race for a vaccine and a cure rages on.

The grim reality of an unprecedented deathly virus has impacted our lives in many ways. But thankfully, the relentless efforts of the scientific field have surprised us with most-welcomed great news; the COVID-19 Vaccines and Antiviral Treatments are coming sooner than we expected. The clinical trials results overall are very promising and it might mean that there is light at the end of the tunnel after all. On top of that, there is a coalition of top-tier well-known manufacturers that will work together to begin the mass production of the vaccines and treatments to protect humanity and restore some normalcy into our lives. But let’s just think this through before we pop the champagne bottle when we start the first product batch! I mean, it is a huge milestone and we are almost there, right? Not quite so.

There are 7.8 billion people on this planet, not counting some 5 astronauts (at the moment of this writing) that eventually will return from their space mission. This represents over 195 countries (give or take based on what is currently recognized as a country) that will require treatment against COVID-19 sooner rather than later. This is a huge challenge and what it means is that the manufacturing of the vaccines and antiviral treatments has to be handled with utmost precision if we want to supply the market efficiently and in a timely manner.

...the manufacturing of the vaccines and antiviral treatments has to be handled with utmost precision...

I’m personally happy about the encouraging news, but what keeps me awake at night is knowing first-hand the challenges of the manufacturing cycle, especially regarding new products and batches release requirements. Regulatory agencies like FDA, EMA, HPFB, PFSB, ANVISA and TGA among others are going to enforce their product release requirements as we cannot afford to have a set back that will cost human lives. As a matter of fact, I read in recent news that the EMA has set up infrastructure for real world monitoring of COVID-19 treatments and vaccines.

So, what do we do? How can we prepare for the upcoming challenges if we want to save the world and pop a new bottle of champagne in a well-deserved celebration 🥂🍾?

All the top-tier pharma manufacturers will work for sure around the clock for weeks and they are probably already planning for the upcoming load of work. A high-level way to see it is using the SIPOC method. Now, the input and collaboration of experienced consulting professionals have proven crucial during the scale up and technology transfer stages of new entities. For example, large-volume manufacturers are recommended to certify more than 2 suppliers per raw material, giving priority to those deemed as critical components. This is something that can be done at early stages of clinical phases. It is essential to pay attention to the quality agreements and on-site audits to classify the suppliers properly. The input of materials will require the best parameters and quality testing possible. This is because the quality of your final product is in part the sum of the quality of your materials. Seasoned professionals can help the manufacturing organization in creating a solid foundation that will ensure a seamless transition into a compliant manufacturing stage.

For all the incoming and material management, including its documentation, consider the assistance of a consultant SME that can provide comprehensive training modules, develop easy to follow procedures and issue complete forms. As for the actual manufacturing processes, each organization needs to have GMP documentation (work instructions, forms, batch records, reports, etc.) in place that is easy to read and understand, posses a chronological order and is aligned to the procedures that the experts of the production areas know. In addition, a professional consultant can help the company in identifying the critical manufacturing and packaging steps while relaying this information to the employees by means of training and review of documentation per phase (“Quality on the Shop Floor” approach).

Finally, a large amount of GMP documentation for review and approval (i.e. Non-conformances, CAPAs, Change Controls, Technical Reports, Risk Assessments, etc.) that could represent a roadblock for product release is expected. Quality on the Shop Floor initiative has proven to be effective in the reduction of deviations and improvement of processes, while the review of GMP documentation per phases expedite the final release of records and help addressing documentation issues before becoming non-conformances. Consultant SMEs can provide the additional hands-on expertise to cover the compliance of the overall requirements to ensure successful and timely release of the products. Furthermore, a professionally executed quality risk management will ensure the company addresses the issues efficiently while avoiding unnecessary requirements and helping to classify the actions based on risk level.

As we can see now, there is hope that COVID-19 Vaccines and Antiviral Treatments are looming near. There are significant challenges ahead though, and the manufacturers have to plan, execute, evaluate and adjust if we want to overcome this threat and resume our normal lives. The support and advice of professional consultants might prove crucial in the timely manufacture and delivery of those life-saving medications to the world. Humans have shown time and time again that we are a resilient and intelligent species. The ultimate challenge is to deliver this vaccine in an expedited way, while ensuring its safety, identity, strength, quality and purity in compliance with all regulatory agencies’ requirements. Let us all contribute to this race for a vaccine so that we can save humanity once again. The lives of 7.8 billion people (plus 5 astronauts 🧑🏻‍🚀) depend on it.