CPhI NA / Informex - 5 minutes with... - page 2

CPhI NA
/
InformEx
Aslam Malik, CEO of Ampac Fine Chemicals
What’s new with Ampac?
We have been very busy, like all of the US-based CDMOs. We have made a lot of investments in
quality and other initiatives that we have been working on for years. One is continuous improvement,
where we have implemented Kaizen, and it is really paying off right now. This started in our facility at
Rancho Cordova in California and we have started expanding it to our other facilities. We recently
bought Boehringer Ingelheim’s former plant in Virginia. It’s a beautiful plant that was built to pharma
standards, not the usual dedicated ex-Big Pharma site: it used to be Lee Chemicals and was famed
for multi-purpose products, then Boehringer Ingelheim acquired it and built it up to the required
standards, so a large part of the facility is extremely flexible.
What does this new site bring to you?
It brings in additional capacity, notably in controlled substances. This is a good part of the market
to be in. Until now, we have mostly been in non-opioids in this space, but we are a custom
manufacturer and we will manufacture what’s needed out there. The site also brings us much higher
on the high potency side than we had been before. At Rancho Cordova, we have been able to
go to 0.1 microgram containment, this Virginia facility enables us to go to the highest level of containment, down to nanogram. I think
the demand is there for that. We have started production there on our first product, and now we will bring on additional products.
Generally, we are seeing growing demand for all of our key capabilities: simulated moving bed (SMB), high containment, high
potency, highly energetic chemistry
Is SMB becoming more popular?
The acceptance level for SMB has gone up and it is used a lot now. There are still very few commercial-scale SMBs in the world,
however, so when companies have done trials successfully, for kilo quantities they come to us and we can take it up through
the stages to hundreds of metric tonnes. We have active production in both of our large units at over 300 tonnes. SMB is a great
technology: it enables you to make your product in a high yield, plus you can recycle all the solvents, so we can be very competitive
on the cost side.
Is business good generally at the moment?
Yes. There are not very many suppliers in the States and close to zero with any open capacity, so our Virginia facility is very useful.
We also built a new large scale cGMP facility at Rancho Cordova and commissioned it on 20 April. It’s world class and very
complementary to Virginia. Basically, we saw the need coming up for capacity and started planning for it through organic growth
and then through acquisition. Now we are one of the few large-scale cGMP manufacturers in the US with capacity to offer, so when
people started to make a U-turn from Asia, we were ready. We have also introduced AMPAC Analytical as a separate company doing
independent testing, as the need for this has grown so much. We have key specialised capabilities, like ICP for heavy metals, that we
have been doing for many years, and XRPD and other services involving genotoxic impurities. The timing was good here too.
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