By Louis Garguilo, Chief Editor, Outsourced Pharma
A biopharma executive I spoke with believes the industry should receive a more complete rendering of what we’ve learned from our COVID-19 experience.
He’s disappointed critical aspects have not been adequately addressed in the multitude of “one year after COVID-19” analyses he’s read or heard.
He has no ties to the mRNA or other vaccine companies, nor connection to COVID-19 therapies.
He is an active participant in our industry with vast drug development and manufacturing experience.
His message is one we are familiar with, but I’d agree we have not sufficiently elucidated:
Our drug development and manufacturing outsourcing model is integral to taming the pandemic.
Because of this model, and without in any way detracting from extraordinary efforts at companies such as Moderna and Pfizer – and all vaccine developers – the world has so quickly received mass produced mRNA vaccines.
Had this particular coronavirus struck a decade or more ago, we would have fared far worse.
Of course mRNA platforms, while in stages of development, were not as advanced from a scientific or technology standpoint as today, and over the years related technologies have advanced.
But the point is that in 2020, vaccine developers could immediately reach out for assistance to an array of highly skilled contract developers and manufacturers.
In fact, many relationships were already established, and helped grow an expanded network
And – quite remarkably – CDMOs not involved with mRNA then found ways to, shall we say, turn on those needed capabilities.
Today, perhaps hundreds of mRNA and other emerging vaccine developers are utilizing these partners.
They are able to multiply the capacity of their companies.
And, come to think of it, that’s actually not a bad definition of outsourcing.
In fact, we have moved so far along the outsourcing path, it feels quaint to bring up the “old model,” when pharma was determined to keep activities internal.
Perhaps it’s precisely this ubiquitous acceptance of outsourcing that has led to our not fully acclaiming the model during the pandemic.
But now fully considered, let’s take it upon ourselves to inform people how our system of contract development and manufacturing positively impacted their coronavirus experience.
COVID-19 provides us many lessons.
It also helps refocus on the blessings we have. Our partnering model is one of those.
So it was not the older, proven vaccine technologies that were able to move forward as quickly as the newer ones.
These technologies were greatly enriched by CDMOs.
The accessibility of external capabilities, instrumentation and machinery at scale – all those items that could not be available internally, facilitated the number of doses available today, and into the future.
Again, there are hundreds of emerging biopharma companies trying out new vaccines – most with severely limited internal resources.
Without a potent CDMO response, these hardworking professionals cannot reach the speedy critical mass they desire.
We could not adequately try out the array of potential vaccines against the pandemic that we did, nor keep up with emerging virus variants.
But with these vaccine types in play, we can surface winners like the mRNA.
Think about it:
At the start of this pandemic, how many thought mRNA vaccines – with no track record of deliverability – were going to prevail?
But we are in an era when brilliant professionals in small companies like BioNTech can push forward and end up delivering on a global-dosage scale.
Of course, astute Outsourced Pharma readers will also acknowledge the biopharma/Big Pharma partnering that played a major role in our success.
There is also the exceptional level of collaboration between Big Pharma and Big Pharma in the mass manufacture of COVID-19 vaccines.
But here, too, perhaps we can suggest this:
These agreements were informed by years of partnering relationships practiced within our outsourcing model.
What’s It Take To Make?
What went into the making of these vaccines?
On a basic level is the synthesizing of the strand of mRNA. This has been long in research, but I’m told is relatively scalable now; the technology itself currently not overly challenging.
It appears many organizations are capable of this – although it requires fairly large CDMOs for current purposes.
The fill-finish process, I am also told, is not particularly challenging today; here, too, there appear to be a number of capable partners.
That we can write the sentences immediately above is again testament to a strong, advancing service-provider industry.
Still, there are components of these vaccines that remain challenging – particularly the lipid nanoparticles (LNP). This, too, is a science and technology long in research and ongoing development, both at biopharma and service providers.
The LNP a BioNTech or Moderna need have been expressly designed, and require very specific conditions.
In fact for most all materials (and processes), suppliers and CDMOs are essential to the specific vaccine efforts.
Most do require large suppliers with ample available capacity, but in other cases, specialty partners also provide key support.
There’s another element involved:
CDMOs are teachable.
They are quickly brought up to speed on running new processing equipment and techniques needed by the sponsor biopharma.
A part of this is benefited from an already established, high degree of customer trust, and effective communication on both sides.
CDMOs are not infallible. Readers know only the last few days we’ve seen troubling reports of fallibility related directly to COVID-19 vaccine outsourcing.
Improvements are always needed – particularly at the nadir of a successful but fast-paced time like we are now experiencing.
Taken together, a global outsourcing model has facilitated COVID-19 vaccine development, and led unheard of, accelerated global production.
So let’s give a deeper credit to this segment of our industry. Like the vaccine sponsors themselves, these CDMOs and the talented people within deserve worldwide acknowledgement and respect.