Labs are flexible and allow clients to configure them to
suit their particular testing needs.
work lounges along with fully modular lab spaces that can be
designed, equipped and ready-to-go upon their arrival.
HISTORY AND BACKGROUND
Bioreliance has been providing services to the pharmaceutical industry since 1947. First, with the production of
serum for cell cultures and tissues and commercial supply of
cell cultures and reagents. In 1955 the company created the
first biosafety product for polio vaccines and also developed
safety testing for the first rocks brought back from the moon.
In 2012 BioReliance was acquired by Sigma-Aldrich
Corporation in order to provide their customers with a sin-
gle-point provider whose services would span the entire drug
discovery, development and commercialization spectrum. As
part of the SAFC business unit, BioReliance provides cost-ef-
fective contract services, offering more than 1,000 tests or
services related to biologics safety testing, specialized toxi-
cology and animal health services. BioReliance
also offers contract manufacturing services for
gene therapy and vaccine products.
For the past 25 years, the company’s expertise has been focused on the safety testing
of products made via biomanufacturing processes. About 80% of its revenue derives from
the testing of biological (“large molecule”)
products for human use according to regulatory specifications. Testing of these products
is important because unlike small molecule
drugs made by chemical synthesis, there are
inevitably variations between batches in biomanufacturing processes; additionally, there is
potential for contamination by human pathogens. The remaining 20% of the business’s activities are focused on small molecule product
testing, and animal specimen testing.
CLEARANCE SERVICES – EXPLAINED
In basic terms, clearance services involve
replicating a purification or separation process
on a small scale, spiking the material to be pu-
Let’s face it. Travelling for business reasons is not very glamorous. Beyond the inevitable snafus of just getting to your destination, there are always worries of technology glitches and concerns of staying in touch with the home office to deal with.
In the highly specialized, yet fundamentally important,
biological testing services segment of the pharmaceutical
contract services industry, the deficiencies of business travel
can be magnified by the length of time spent on-site monitoring testing procedures, and the lack of a dedicated space to
call your office away from home.
BioReliance, a company that provides testing and manufacturing services to pharmaceutical and biopharmaceutical
companies, realized that the absence of full featured and
fully customizable biological clearance testing facilities was
an opportunity. The company’s recently opened testing facility in Rockville, MD offers their clients private and secure
■ By Mike Auerbach, Editor in Chief
BioReliance builds a biologics clearance service facility that’s a home
away from home