the site is particularly suitable for designing shorter, cost-effective synthetic routes
for producing APIs and advanced intermediates. The site also produces and sells
pre-formulated nitroglycerin products for
the pharmaceutical market.
In each case, the FDA inspection confirmed that commercial APIs produced
at each site are suitable for drugs marketed in the U.S.
“This success has been made possible by
the day-to-day good practices adopted by
every colleague involved in operations. The
robust system implemented by Novasep’s
quality assurance team ensures these high
standards,” said Jean-Claude Romain, vice
president of quality at Novasep.“These three
successful inspections reward this long-term
teamwork and commitment.”
BMS Evolves U.S. Geographc Footprint
Bristol-Myers Squibb Co. has made
changes to its U.S. geographic footprint
aimed at strengthening capabilities of its
R&D hubs in Central NJ, the San Francisco Bay Area and Cambridge, MA, while
further integrating biologics development
with clinical manufacturing at key sites.
Previous investments include the development of a state-of-the-art research facility in Cambridge, the expansion of its
Redwood City research campus in the San
Francisco and the recently opened Princeton Pike facility in Lawrenceville, NJ.
BMS will invest in the construction of
a new R&D building at the Lawrenceville
campus that will co-locate lab-based Discovery and Translational Medicine activities, construction at its New Brunswick, NJ
facility to support biologics development,
and construction to continue expansion of
its biologics campus in Devens, MA.
The company also plans to initiate a
phased closure of its Hopewell, NJ site by
mid-2020 and will not renew its lease at
the Lake Union Steam Plant site in Seattle, WA in 2019. The company has confirmed plans to close its Wallingford, CT
site by the end of 2018, and it will no longer build a Connecticut Development site.
The company expects many of the roles
from Wallingford, Hopewell and Seattle
will transition to other U.S. locations.
“These important changes to our U.S.
geographic footprint will ensure we have
the structural, operational and financial
flexibility to deliver as effectively as possible
on our mission for patients,” said Giovanni
Caforio, M.D, chief executive officer, Bris-
tol-Myers Squibb. “Today’s announcement
underscores our commitment to make the
right investments to continue to deliver on
the promise of our pipeline and to bring
transformational medicines to patients, to-
day and in the future.”
Catalent Joins PSCI
Catalent Pharma Solutions has joined the
Pharmaceutical Supply Chain Initiative
(PSCI). Catalent is the first CDMO to join
the PSCI, which was set up in 2006 as a
non-profit organization to unite pharmaceutical and healthcare companies that
share a vision of better, social, environmental and economic outcomes in the
communities, sharing knowledge and expertise to drive complex, global change.
“We are proud to join some of the biggest names in the pharmaceutical industry
in the PSCI to promote responsible supply chain management and better business conditions across the industry,” said
Alessandro Maselli, senior vice president
of global operations, Catalent. “
Catalent operates as a global business, and it
is through international outreach initiatives such as the PSCI, where like-minded
companies come together, that we can
demonstrate leadership in this critical area
and forge a long lasting, positive impact,
not only on our business practices, but the
industry as a whole.”
Catalent recently named Shannon Trilli
as its director of corporate responsibility,
who, along with the other members of
the company’s Corporate Responsibility
Council, oversees Catalent’s existing initiatives in sustainability and maximizing
WDSrx’s TX Facility Receives
WDSrx’s facility in Sugar Land, TX, has
received Verified-Accredited Wholesale
Distributors (VAWD) accreditation by The
National Association of Boards of Pharmacy, a national organization that helps
ensure public health and safety. The facility became operational in December 2015.
WDSrx provides third party logistics ser-
vices to the Life Sciences industry. VAWD-
recognized facilities help prevent counterfeit
drugs from entering the U.S. pharmaceutical
supply chain. VAWD accreditation involves a
thorough evaluation and analysis of opera-
tions and procedures, overseen by the Na-
tional Association of Boards of Pharmacy.
The review of operating policies,
procedures, licensure verification, facility screening and evaluation at the Sugar
Land warehouse took place over several
months. “We are gratified that VAWD accreditation was approved for the WDSrx
Texas location so soon after the facility
opened for business,” said WDSrx president Adam Runsdorf. “VAWD standards
demand the highest level of professionalism and accountability and this recognition reflects our team’s dedication to our
clients and to patients.”
Facilities with VAWD accreditation undergo annual compliance reviews and on-site surveys once every three years to ensure the integrity of the designation. The
company’s Boca Raton, FL facility received
VAWD accreditation in 2011.
Vetter’s Skokie Site Launches New
Clinical Syringe Filling Line
Vetter’s Skokie, IL site has successfully
manufactured batches for use in early
clinical trials on its new clinical syringe
filling line. The line is part of expansion
activities undertaken at the Skokie facility
to meet customer demand. It also includes
an increase in storage that is designed to
help manage the growth in syringe fills
and overall larger batch sizes.
The site began full operations in late
2011, and has grown to include six new
chest freezers, two upright freezers and
two refrigerator units. As a result, storage
will be expanded by the end of the year to
increase capacity by 150%.
The company has also successfully
launched an aseptic syringe filling line.
“Year to date, a double digit number of
clinical batches have been manufactured
for customers and we anticipate a significant increase in the number of batches in
the coming years,”said Dr. Susanne Resatz,
president of Vetter Development Services
USA. This reflects the trend the company
sees through its continuous dialogue with
new and existing customers, as starting syringe work in the early clinical phases can
cut up to 18 months off time-to-market.
“Given our experience at this facility with
filling and lyophilization, many of our customers are returning for development work
for a second, third, or even fourth molecule.