Scottish CMO Sets Up Shop in U.S.
Symbiosis’ business development director Joanne Anderson weighs in on biologics fill/finish trends
Sterile manufacturing specialist Symbiosis Pharmaceutical Services is a contract manufacturing organization
(CMO) that specializes in the cGMP manufacture and sterile
fill/finish of vials for clinical trials and commercial supply. Back
in 2015, the UK-based company made the decision to strategically focus on the North American market after identifying
a surge in funding for early stage biotechs. Earlier this year,
Symbiosis opened a new commercial site in Cambridge, MA,
to support its East and West Coast clients
with its vial-filling services including liquid and
lyophilized formulations in injectable dosage
forms. Joanne Anderson, business development director at Symbiosis, talked with
Contract Pharma about the company’s recent expansion as well as biologics fill/finish trends in
today’s market. —TW
Contract Pharma: How would you describe
the current biologics fill/finish market?
Joanne Anderson: The market will always be subject to change, but we believe
there is significant market demand for
aseptic manufacturing capabilities for biologics. This has been boosted by a positive
investment climate in the biotech space,
particularly in the U.S., which in turn is
facilitating the development of new biological drugs, increasing the depth of an
industry-wide drug pipeline and fueling
demand for outsourced manufacturing
services to bring products to the clinical
Within the fill/finish market customers
need to choose whether to work with a big
one-stop-shop service provider or smaller,
more specialist and flexible partners. Specifically, it comes down to what will get
the client to clinical trials in the safest and
quickest route they possibly can.
CP: What are the main trends in the biologics
fill/finish market today?
JA: Fill/finish is historically one of the most
outsourced activities due to the high cost
of equipment, quality infrastructure and
facility requirements. Many contract manufacturing organizations (CMOs) have
experienced a surge in the market due to
several factors, including the decrease in
the amount of high-quality CMO capacity
available for aseptic fill/finish.
There are specialist CMOs such as
Symbiosis whose focus is on fill finish and
we have built an operational flexibility to
move our clients through the clinical development stages quicker than our larger,
less nimble competitors. In contrast, several of the larger CMOs are looking to extend their service offering to align with the
one-stop-shop service provider model.
The industry is also seeing lots of consolidation, with many mergers and acquisitions taking place to allow CMOs to expand their service offerings and reach new
geographies. This is leading to a revival of
the ‘one-stop-shop’ model that big pharma was made up of years ago.
We believe that there is a need for specialist CMOs to deliver the agile and responsive service that is required in today’s
complex and fast-paced drug development landscape.
There is a positive investor climate in
the market, which means that drug developers are under increasing pressure to
demonstrate the success of their promising molecules at an early stage. Experience
has taught us that there is a real market
demand for rapid access to manufacturing slots. This can help to make up for lost
time in the earlier project stages.
This is particularly true in the area of
biologics where complex and novel drugs
require specialist expertise and a flexible
and cost effective process. Therefore, op-
portunities to speed up time to clinical tri-
als and minimize losses during drug prod-
uct manufacture are demanded, and our
ability to meet these needs is a major con-
tributing factor to our growth and success.
We also find that small and mid-sized
drug developers value cultural fit and true
partnerships when selecting a CMO for
their projects. Often this requires a smaller, nimble CMO that can deliver a personalized service.
CP: What do you believe are the key factors
to success in the biologics fill/finish market?
JA: Success in fill/finish outsourcing is
underpinned by technical capabilities
and effective communication on both
sides of the supply contract. The relationship between the client and service provider is fundamental.
As a result, we are seeing more and
more clients moving away from tactical
outsourcing initiatives in favor of a rela-tionship-oriented strategic partnership
with CMO partners across a collaborative
Due to the nature and complexity of
sterile fill/finish, most drug developers
need a long-term vendor that will invest
time, energy and resource into achieving a
The long-term benefit for a CMO like
Symbiosis is we grow and scale-up as clients’ products move through phases. It