Seems like there is a need for contract manufacturers for cell and gene therapies. The book I’ve been reading, Jump-Starting America (Gruber and Johnson 2019), appears to be describing a problem similar to what chip designers faced that TSMC solved with fabs:
The United States is falling significantly short in providing the manufacturing resources needed to turn these genetic breakthroughs into new products. One problem is the enormous start-up costs; the cost of setting up a large-scale cell or gene therapy manufacturing facility can be upward of $200 million…these high costs are well beyond the range that is supported by venture capital investors, so start-up drug companies have no way to finance their own capacity. As a result, some 80 percent of gene and cell therapy companies outsource to contract manufacturing organizations (CMOs), facilities that lease their space to drug companies for testing and development.
There is currently lots of demand:
Existing CMOs are struggling to keep up with demand, however. Wait times at CMOs currently average over sixteen months, and the current shortfall in worldwide cell/gene therapy manufacturing may be about five times their current capacity.
I think there’s an opportunity for something Taiwan is good at, i.e. manufacturing processes:
While CMOs are expanding, they are finding it difficult to do so fast enough in large part because current manufacturing technologies are underdeveloped and referred to by insiders as “outright primitive” and “incredibly labor-intensive.” Rather than using closed, sterile bioreactors (standard for most traditional drug manufacturing), current procedures can require technicians to manually transfer materials between open plasticware. Under these modes of production, it is “not possible to achieve significant economies of scale that can support commercial viability as production levels rise.”
One potential problem may be that the complex relationships required may not fit Taiwan’s quarrelsome culture:
Expanding manufacturing access will require substantial coordination and collaboration that is not in the interest of any one manufacturer–or any one VC financier. Due to the high setup costs of the requisite infrastructure, manufacturing platforms are only economical if the fixed costs are spread across mulitple products. But doing so requires sharing commercial rights and production information at an unprecedented level.
Hmmm good topic and is an incredibly exciting area that I’d like to get (back) into . One issue is that cell and genetic therapies are quite diverse, more diverse than ssminconductor processes. Often you’ll need separate approval in different countries.
But overall yes there’s probably a gap there as mentione, but it’s not always on the manufacturing capacity side as much as getting that therapy approved in this or that country. Costs see definitely a big issue though for patient access but the kind of scale we are looking at is different than a semiconductor chip. Whereas you could knock out a single chip for millions of customers in a cell or genetic therapy you often have just one customer , each therapy can be that personalised.
There’s a few Korean companies doing contract pharma manufacturing. Celltrion is one. Also, Samsung set up a biotech company a few years ago, which already has the 4th highest market cap in the Korean stock market.
They need to suply the GMP documentation to be an approved supplier. If it’s a biosimilar they have to provide a lot of data to show how similar it is to the original approved drug.
Monoclonal antibodies wiki
There’s a local control monoclonal manufacturer here in Taiwan too.
Oyster asked about cell and genetic therapies which is something quite different , they are much harder to scale up , party because cells are trickier to handle, but mostly because these are personalised individualised treatments. You are often taking the patient’s own T or B immune cells out, engineering them or training them to recognize an object as foreign e g. Cancer cell, multiplying them to a massive degree, and then reinjecting them back into the patientbwhere they are then supposed to help recognise and kill that cancer cell.
At the moment those kind of therapies are actually classified as a ‘drug’ but they are more like a production line that is on-site at a university hospital or institute that is operated with a commercial partner.
Yes it would be great if you could just collect the cells from the patient , freeze them , mail them off and get them back in a week or two all ready to go to just inject back in. I guess that will happen in the future for cell therapies.
Genetic therapies are even more diverse again. There are rna blocking or rna promoting drugs (oligo drugs ) that are showing a lot of promise. These oilgo drugs could also be contracted out for manufacture but again each drug is going to require separate approvals. Japan is big into researching these oligo drugs and stem cells as well!
The therapy company. It is their therapy, so it is on them to get BLA approval.
When the therapeutic company files for regulatory approval, they are going to need to prove that the manufacturing is sound. The contract manufacturer will contribute alot here. So, in a way, it’s a partnership.
There are parallel approval processes in the biological, pharmaceutical, and medical device sectors. I guess its something like making sure a non-medical consumer product follows GMP standards, although the GMP certification may be sufficient. In a health product approval, specific data will be presented throughout the process and the CMOs will work with the sponsor (i.e., therapy company) to provide whatever data is needed
Fascinating topic. This is right up Taiwans alley! Not just cell therapy but so many different biotek sectors are so insanely well suited for Taiwan to manufacture. Im not well versed in the above topics, but in the area of agriculture oriented things taiwan is doing it. There is the big AG park in Pingdong which looked hopefull 10 15 years ago but is plagued by corruption and all around idiocy so still sits half empty. That place alone could easily be for biotek what Hsinchu is for regular tek.
Taiwan is actually very very good at this line of work (manufacturing, refining, processing etc) and in biology(especially ag and even medicine) they seem to hold their own quite well on the world stage. I have high hopes for taiwan in these industries!d
I agree with you and feel the same way. But this isn’t something that you can just switch over to. From what I’ve heard, this move into biotech and it’s related sectors began 20 years ago. Part of the thinking was that there were so many Taiwanese scientists and chemical engineers in the life sciences in Western countries, that a switchover from 3C industries would not be difficult.
Scientists came back. Frameworks, policies, etc were put in place. But what wasn’t in place yet were people on the ground here in Taiwan. The best talent in academia was still going into electrical engineering and high tech industries. If you had the choice, would you get an EE degree and join a powerhouse like TSMC – with all its options and pay packages – or take a flyer on a new career path and hope (dream) of the government? It has been 20 years, and this pool of talent is still being developed. It’s coming, but it has been slow.
Btw here is the life science park in Zhubei in Hsinchu - one of several infrastructure components that have been long in development.
@Brianjones seems to be the expert on this but from what I understand the problem is that, as complicated as electronics manufacturing is Silicon photolithography scales very well and concerns much fewer moving parts to come together.
Taiwan is small, I don’t we can create the whole biotech ecosystem here the way we did with electronics. Not to say Taiwan is hopeless there, it is actually doing alright even now but I think it needs to choose its battles and stick to super high value parts of the supply chain. Like Switzerland and Singapore with pharmaceuticals.
Consider this. Unlike tech parts which require large amounts of resources mined/processed abroad, many biological products can be grown in house (Taiwan) with far fewer imported source materials. Things like algae are a great example where taiwan could really shine using pollution/industrial waste as a decent hunk of the feed input. Stuff like this is, relatively, simple to scale and taiwan is extremely capable of doing big.
For Singapore, look up the Tuas Biomedical Park, where you can expect to find R&D offices and labs of Big Pharma to large multinational Contract Manufacturers like Lonza to biotech startups – so practically the whole value chain up to where R&D hands off to Commercial. Commercial offices would be located downtown. I would expect GE Healthcare and other equipment makers and device makers to have similar spreads – commercial offices downtown and R&D/logistics in science parks like Tuas and the Singapore Science Parks I and II (where major CMO Merck Millipore has its operations)
