Lyophilization R&D Services For Cytotoxic Drugs

Cytotoxic drugs are used as part of a chemotherapy regime and form the bedrock of this form of cancer treatment. Recently, their uses have expanded outside of the cancer envelope to treatment for certain skin conditions (e.g., psoriasis), the treatment of rheumatoid and juvenile rheumatoid arthritis, and steroid-resistant muscle conditions.

Cytotoxic drugs have an effect of preventing the rapid growth and division (mitosis) of cancer cells. However, cytotoxic drugs also affect the growth of other quick dividing cells in the body such as hair follicles and the lining of the digestive system. As a result of the treatment, many normal cells are damaged along with the cancer cells.

These highly potent compounds have the advantage of being required in small doses, however throughout their development and production journey, from R&D to actual administration, there is a constant need for secure handling is necessary due to their toxicity.

Whilst the cytotoxic market is maturing, with some “blockbuster” therapies losing patent protection, new products within this space are constantly being developed for traditional as well as more recent applications. Market assessments indicate that from a market value of $13.7B in 2008, the market will reach $18.7B in 2012 across the major pharma markets in North America, Europe and Japan.

Two factors drive this growth: firstly as the population lives longer, the incidence of cancers and conditions such as arthritis are also on the increase; and secondly cytotoxic drugs have taken a role in the development of personalized medicine where therapeutic products are matched and formulated to individual needs.

Cytotoxic products are therefore likely to remain a significant feature on an increasingly wide part of the therapeutic landscape.

Safe handling of cytotoxic compounds

A limited number of companies have the capabilities of handling cytotoxic compounds safely and efficiently and even fewer offer expertise in R&D. BTL is unique in now being able to bring together its R&D expertise in the lyophilization of products, with a dedicated facility for cytotoxic products. The facility is constructed to a Class 7 standard and offers exemplary separation and safety features. This facility went live in March 2012 and has already attracted an impressive order book and interest from all parts of the cytotoxic development community. This facility will match the cytotoxic marketplace with BTL’s existing product and process development skills of:

• Characterization
• Formulation development
• Lyophilization cycle development
• Development and product sale containment
• Small scale production
• Scale up advice and technology transfer