also gives us a strong understanding of
each client’s product and process, which
we may have developed, adding huge
value when it comes to increased batch
outputs and meeting clinical deadlines.
We also increasingly see that new drugs
are being developed for very specialized disease states and unmet needs. This results in
much smaller patient populations and hence
smaller batch sizes, which has a significant
impact on operations and the technologies
that are the best fit for the application.
We have focused on flexible equipment
and single-use disposable technologies at
Symbiosis to enable fast product release,
the flexibility to produce small sterile
batches for trials and eliminate potential
Having specific experience in handling
biologic drug substances is a significant
advantage for a specialist CMO like us as
it reduces the potential for process loss
and risks when handling some very high
CP: And what are the main barriers/issues
in the market?
JA: Fill/finish is often characterized as the
most critical step in drug manufacturing
due to its highly specialized nature, which
makes it difficult to get products to market or clinical trials. In addition to being
extremely costly, fill/finish operations are
quite rightly subject to extreme scrutiny by
We have recently seen more stringent
requirements from the regulatory bodies,
with aseptic fill/finish one of the main areas of focus and quality standards remaining a major challenge for some CMOs.
Clients are rightly vigilant when placing
their projects with sterile CMOs. By demonstrating robust and continuously improving quality systems and a strong regulatory track record with the MHRA, who
are regarded globally as a gold standard,
clients are reassured when dealing with our
team, knowing our operations absolutely
comply with prevailing regulations.
Domestic market preference to have
manufacturing located near to the demand could increase the presence of facilities in developing regions, but it will take
time to build experience and confidence
there. Aseptic fill finish is the highest risk
mode of drug product manufacture, hence
confidence in the facility is key.
We expect to continue to experience
growing demand from U.S. biotechs that
are undertaking clinical trials in Europe.
By choosing a GMP manufacturer based
in Europe, drug developers can ensure
compliance with the QP standards required to release a drug product for a European based clinical trial.
In reality, the industry and our sector
is truly global. Within drug development,
clinical trials are now conducted all over
the world. Most clients are concerned with
many other factors beyond locality.
CP: What do you think the future holds for
the biologics fill/finish market?
JA: The outsourcing sector will no doubt
continue to grow over the next five years,
with particular growth in the parenteral
manufacturing space coming from biopharma companies as they begin to progress new drug products thanks to an increase in funding.
Despite the demand for services, due
to the substantial barriers to entry and
increasing quality demands, we don’t ex-
pect to see many new players entering
the market. While many CMOs continue
to expand their offerings, there will con-
tinue to be demand for niche manufactur-
ing services from specialist providers that
can offer the flexibility needed to meet
increasingly tight timescales in the drug
Time and flexibility often have a very
high influence on the selection of a fill/
finish CMO partner, and clients can
sometimes underestimate the complexity
of setting up fill/finish operations that are
suitable and scalable.
As a result of this we are also seeing
more experienced innovators engaging
external support earlier in development,
and some are seeking more strategic relationships that begin at an early stage of
development but consider the needs of
later stage supply.
CP: How will Symbiosis capitalize on this?
What does the future hold for the company?
JA: As a result of increased global demand, Symbiosis has grown by around
40% over the last year and has also continued to recruit steadily, increasing staff
by 30% to meet demand for its specialist
aseptic fill/finish service.
Europe and the U.S. continue to be our
strongest markets. We have experienced
significant growth in the U.S. in recent
years and expect this to continue as demand for our expertise in filling biologic
and small molecule products, combined
with our ability to offer rapid access to
sterile manufacturing slots, has been very
well received by preclinical and Phase I-III
biotech and pharma companies.
Since strengthening our U.S.-focused
personnel and developing our relationships with networks like MassBio and
ISPE, we have significantly grown our U.S.
client base, which is projected to account
for around half of our revenues in 2017.
In January, we opened a commercial
site in Cambridge, Boston, MA, to support our clients on both the East and West
Coast U.S., and provide a base for reaching new customers in this territory.
Regulatory compliance, technical capability and operational flexibility are still core to
Symbiosis’offerings. It’s about the level of service you can deliver to your customers, how
quickly you can offer them access to your services, along with an absolute ability to consistently demonstrate regulatory compliance of
the highest standards. CP
“There is a positive
investor climate in
the market, which
means that drug
developers are under
to demonstrate the
success of their
at an early stage.”