Enhanced safety to support changing drug development technology

by Michael J. McDowell, Executive Vice President, Business Development and Project Management, Eurofins BioPharma Product Testing; Rachel Brady, Lead Safety Officer

To maintain our position as a valued partner for our drug development clients, Eurofins Lancaster Laboratories is constantly investing to enhance our capabilities and fulfill our value proposition of offering the broadest and most comprehensive range of testing services available. To support many of the new biopharmaceutical modalities, investing in cutting edge instrumentation is not enough. We have also made significant investments to enhance our facilities and improve our procedures to assure a safe working environment for our employees.

The Bio/Pharmaceutical industry is the most research intensive industry on the planet. As such, technology changes at an unprecedented pace. Some recent technologies that have received attention and significant funding include; gene therapy, oncolytic virus therapy, and conjugated molecules. The most common being antibody-drug conjugates. All of these modalities present safety concerns that require special procedures and facilities.

Most gene therapy development candidates use a viral vector to introduce genes into recipient cells. To perform comprehensive stability and release testing on these development candidates requires BSL-2 laboratory facilities. Oncolytic virus candidates have similar requirements. BSL-2 labs are common in virology, molecular biology, and microbiology areas. BSL-2 containment is not common in chemistry or biochemistry labs. To support our gene therapy and oncolytic virus clients, we have recently commissioned a new 600 ft² BSL-2 biochemistry laboratory. This new lab allows us to perform the compendial (appearance, pH, osmolality) tests and contains HPLC, LC-MS, CE, ICE and spectrophotometric equipment to perform concentration, homogeneity, identity and purity under BSL-2 containment, thus fulfilling our promise of being clients’ one-stop-shop for release and stability testing.

We have also seen a dramatic increase in the need for safe handling of highly potent materials. Much of this increase has been driven by the number of antibody-drug conjugate programs supported by our laboratory and the ever increasing potency of the cytotoxic payloads or “warheads” on these molecules. Oftentimes the free drug and/or the reference material for these ADCs is classified as Category 4/5/6 or OELs < 30ng/m³. Exposure to these highly potent, well-absorbed molecules can cause severe acute and chronic systemic effects that are irreversible.

Protecting our employees and providing a safe working environment is the primary goal of our leadership. To accomplish this goal, we have made significant investments throughout our campus. The most significant of these investments is our new 3,000 ft² highly potent material handling lab. This lab is designed with all of the air handling, containment, and dedicated equipment to test materials classified as Category 4/5. Additional space is designed and planned for an expansion of this lab as this area of testing continues to expand. We have also invested in new ventilation controls for our sample receipt area to ensure the safe unpacking of our drug materials. In addition, our EH&S personnel have worked diligently to implement procedures, training, and a comprehensive safety plan for our campus.

Keeping pace with technology and our clients’ drug development testing needs is part of our DNA. We invite you to tour or audit our laboratories by contacting your Project Manager.