This fact was revealed during a Q&A session following a presentation on trends in biotechnology at Optima Pharma Group's (www.optima-packaging-group.de) open house.
Dr. Vinay Radhakrishnan, principal scientist, drug product & device development at Amgen in Thousand Oaks, CA, told the audience one market driver for pre-filled syringes is monoclonal antibody therapies, rapidly becoming a major chemical modality for pharmaceutical and biotech companies.
Current multi-million dollar offerings include Enbrel, Remicade and Humira, for the treatment of rheumatoid arthritis.
But there are many issues to consider when planning a filling and packaging line for these proteins. The dosing requirement for these large molecules is two orders of magnitude larger than small protein molecules, causing some doses to exceed 150 mg/ml.
These doses may be too large for a pre-filled syringe, Radhakrishnan said, calling for a subcutaneous infusion pump instead. He admitted the market in Europe for pre-filled syringes is much larger than the U.S., but argued that these devices lead to better patient compliance, particularly if in a liquid state. A dose in a pre-filled syringe can be administered at home, rather than going to the doctor who has to reconstitute the lyophilized powder.
Radhakrishnan also noted a shift from reusable to disposable syringes where compliance is again optimized.
Both the silicon oil used to lubricate the delivery device, and vibration during shipping can cause aggregation of the protein which can compromise the efficacy of the drug.
"Tight specifications from the supplier, particularly in the plunger, are critical," said Radhakrishan. "And extensive shipping tests must be done to determine the best method with the least aggregation."
High-speed, highly automated packaging lines are required to compete effectively as well, said Radhakrishnan.
HEALTHCARE PACKAGING ABROAD
Pfizer, Amgen presentations highlight equipment manufacturer open houses in Germany
In early June, Healthcare Packaging Publisher, Jim Chrzan attended two pharmaceutical packaging events in Germany. Every three years, in rotation with the Interpack and Achema events, pharmaceutical packaging equipment manufacturers hold a series of open houses featuring booth exhibits from partner companies as well as technical presentations.
Michael Becker's Pfizer presentation took place on Tuesday June 19th at Uhlmann Packaging's "Live: International Customer and Partner Days" in Laupheim. Partner companies exhibiting included Alcan, Constantia Hueck, Honeywell Specialty Films and Klockner Pentaplast.
More than 500 guests were signed up to attend the three-day event.
Meanwhile, Amgen's Dr. Vinay Radhakrishnan's presentation on the growth of biological products took place before a crowd of more than 100 end users, suppliers and integrators at Optima Group's Pharma Forum in Schwabisch Hall on June 20th. Visitors came from around the globe for the two-day event from such countries as France, Ireland, England, India, Netherlands and the U.S.