The very title of this article is probably a contradiction in terms. There are few other industries where manufacturing is more complex than for advanced biologics – the kind of drugs and treatments that build upon cell and gene therapies, and tissue engineered products.
The manufacturing process, once you are ready for human clinical studies, follows only after extensive process development work where every step along the way will be crucial for your final product to be approved to hit the market eventually – or not. Any mistakes made early in the lead up to manufacture advanced biologics could be detrimental. In a high-risk business such as biotech, and in particular development of biologics, de-risking wherever possible is a priority.
In a high-risk business such as biotech, and in particular development of biologics, de-risking wherever possible is a priority.”
Hence, it comes as no surprise that the investors behind biotech’s in the process of matchmaking with a manufacturing facility often pay close attention to the management’s choice of CDMO, keen on safeguarding a solid choice.
No pressure. Just take a deep breath and keep a cool head. And ask yourself, what is really playing it safe?
One of the coolest minds of this business is Roger Lias, with some +35 years in the biomanufacturing space and responsible for the founding management and growth of several major Contract Development and Manufacturing Organizations (CDMOs). Together, we have looked into some behaviors and mega trends influencing the choice of CDMO.
Word of mouth!
Looking to smaller biotech, it’s not a new phenomenon for them to go for the service provider next door or the one your network used, but in times of geopolitical and financial instability referrals seem to become more important for all services, manufacturing being no exception. Maybe that guy on your board who used to work someplace happens to know someone who is supposed to be really good.
So why jinx anything? Playing it safe. Or not. Are we becoming more geographically biased in our choices and what does that mean for success rates? For sure, proximity to clinical sites and patient population centers is playing a part here and favors staying local. But could it be that distance is becoming impactful for reasons other than rational ones, as the human mind has a tendency to look to “close to home” options for perceived safety? If so, that is unfortunate.
The global hot spots of biotech have everything to gain from staying connected and fighting any tendency of protectionism that might come as a consequence of general uncertainty in post-pandemic era.
Reshoring
Turning our attention to big pharma, they have been in the process of bringing manufacturing back to the original country for quite some time now. It goes hand-in-hand with the psychology described for smaller biotech’s behavior. This trend, of course, was strengthened during the Covid pandemic when Governments’ eyes were opened to the vulnerabilities of global supply chains. This development, in turn, has resulted in CDMOs establishing bridgehead feeder operations to access the US and European market, feeding large-scale facilities elsewhere. The trend we have noted is particularly visible among Asian CDMOs.
In parallel to the reshoring activity ongoing, however, there is an opposite movement where big corporations not wishing to put all eggs in the same basket are diversifying their supply chain. Naturally, the psychology and risk assessment behind localization decisions is somewhat different when it comes to second sources.
Economic climate exerting pressure
As if geopolitical instability and the usual milestone concerns were not enough to keep biotech CEOs awake at night, financial markets are now weak too. With the closing of capital raising rounds becoming increasingly hard, awareness of the importance of cost control and cash preservation is driving management decisions.
No one wants to see their team pack up and leave, but downsizing is now an unfortunate market reality and low-cost alternatives might be deceivingly attractive.
How does this affect partnership dynamics?
The point we are making is that making a clever and rational choice about what CDMO to partner with has never been trickier. But at the end of the day, the core elements of a successful partnership remain the same. Reliability, cost efficiency, and agility to handle disruptions along the way because they will come!
And then, you want your project to be in the experienced hands of someone who makes it their priority to see you succeed. A team that will walk the extra miles, regardless of where they are located. THAT is playing it safe, as safe as one possibly can in this minefield called advanced biologics where pretty much every project is breaking new ground.
Can you afford not to?
This column was originally written by Helena Strigård and Roger Lias for NLS magazine No 03 2023, out September 2023
Helena Strigård, senior advisor, NorthX Biologics (Photo: Kristian Pohl) and Roger Lias, biomanufacturing veteran with +35 years experience in the field
