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Alkermes, Inc. Brickyard Square Manufacturing Facility, Chelsea, Massachusetts
Facility Considerations
 Alkermes, Inc.
develops products based on sophisticated drug delivery technologies to enhance
therapeutic outcomes in major diseases. One of the products in the company’s
pipeline is inhaled insulin, partnered with Eli Lilly & Co. Inhaled insulin
would allow patients with diabetes to receive their therapy without multiple painful,
daily injections. This inhaled insulin product uses the Alkermes patented and
proprietary AIR Pulmonary Drug Delivery Technology that gives highly efficient
lung deposition for the systemic delivery of drugs from a simple and convenient-to-use
inhaler. Alkermes produces large porous particles, that have very low density
through a spray drying process and fills this powder into capsules that are used
in the AIR inhaler. Recently Alkermes constructed a full scale commercial manufacturing
facility, the first of its kind, for producing inhaled insulin using the AIR Technology.
Alkermes considered many factors in developing its plan. The location had to be
close to Alkermes’ headquarters in Cambridge, MA so it could leverage the
R&D knowledge base in Cambridge and continue to attract highly qualified personnel.
The location also had to be large enough to allow for future expansion while avoiding
the high lease costs of the Cambridge area. The site search covered over 40 properties
in the Boston, MA, area. The result of the search was the selection of the “The
Brickyard Square Facility,” a set of four 100-year old brick buildings located
in a historic section of Chelsea, Massachusetts, which is situated next to Boston
on the Mystic River. The site had been abandoned for 10 years and the city was
enthusiastic about the re-development of the site.
 The site consists
of 3.3 acres in an urban area with access to major highways and is only 15 minutes
from Alkermes’ Cambridge headquarters. Construction began in January of
2002 and was completed in April of 2003. A fast track design/build approach was
used to speed project completion. Process development continued throughout construction,
which presented some unique challenges as the design and construction process
had to be flexible to incorporate new findings. The $40M facility was operational
only 18 months after the start of construction.
This facility represents the first commercial scale-up of the large porous particle
technology and it represents a new and innovative application of existing pharmaceutical
spray drying technology to produce the novel and proprietary AIR insulin particles.
Processes/Manufacturing Equipment Employed
In order to manufacture the Alkermes-developed proprietary formulation,
the facility’s main equipment included Niro Spray dryers and MG America
capsule fillers. The product has a low fill weight in comparison to most capsule filling operations
and this posed a problem.
 The solution
involved using the MG America high speed filler (up to 100,000 capsules/hr) equipped
with a net check weight system. Conventional capsule products usually have a few
hundred milligram fill weight and the few milligram variation in empty capsule
weight is not significant if only a post fill check weight is used to measure
the fill weight. When filling only a few milligrams of product into the capsule,
the empty capsule weight variation is on the same order of magnitude as the fill
weight. An innovate solution where check weights were automatically taken by pre-weighing
a capsule, tracking it through the high speed fill process, post weighing the
capsule and calculating the exact fill weight by difference was used. This information
is used in a Statistical Process Control scheme to accurately control the fill
weights.
Alkermes
88 Sidney St
Camgridge, MA, 02139
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California ePedigree Push to 2015 – What does it mean? 
