
Biopharma
Technology Ltd (BTL) have completed construction of a new standalone cleanroom,
enabling them to provide freeze drying R&D services for cytotoxic products.
Freeze
drying is a complex operation and many drug developers outsource development to
contract research organisations specialist in this field. However, few CROs
with freeze drying expertise have the ability to handle cytotoxic drugs safely.
About
Cytotoxics
Cytotoxic
therapies are most commonly used in cancer chemotherapies and work by
preventing the growth of cells. However normal cells can also be damaged both
in patients and anyone else exposed. Cytotoxics are highly potent which means
that from R&D to actual administration there is a need for secure handling.
In
R&D, the safe handling of cytotoxic drugs requires measures that are
significantly more stringent than standard practice. Cleanroom containment,
protective clothing and additional handling procedures are used to protect
staff, to prevent product from escaping from the laboratory, and to prevent
cross-contamination with any other products that may be under investigation.
These factors make it common for cytotoxics to be handled in a separate suite
specifically designed for handling them.
Rather
than take on the costs of an additional laboratory, many drug developers
benefit from partnering with contract research organizations with existing
facilities and additional expertise.
About
Freeze Drying
Freeze
drying is a process used to stabilize high value products including pharmaceuticals.
However,
freeze drying can be an expensive process.
"When
freeze drying cycles are inefficient they become long and costly," says BTL's
Commercial Director Dr Laura Ciccolini. "This is why many developers choose to
partner with an organization specializing in this field. However there are a
limited number of companies with this expertise, and few have the capability to
handle cytotoxic compounds."
About
the new facility
BTL's
new standalone cytotoxics laboratory has been built to provide both an
outsourcing capability to smaller developers, and specific product development
expertise to more established enterprises. The suite contains a full range of
characterization and analysis equipment as well as a pilot-scale freeze dryer.
This enables BTL to offer its full range of freeze drying product and process
development services and small scale production runs for cytotoxic products.
Dr
Ciccolini says, "BTL are now able to provide a really exceptional combination
of world-wide reputation for freeze drying expertise and safe cytotoxic
processing."
For
more
click here