Left to right: Modular biomanufacturing facilities allow projects to be completed far more rapidly and products delivered at a lower cost than traditionally possible.
Systems offer the highest level of flexibility and scalability, enabling production of multiple
products either simultaneously or sequentially and facilitating rapid changeovers.
Caliber has a vast array of analytical equipment in its process development, analytical and
quality control laboratories.
Caliber is a leader in the Plant-made pharmaceuticals (PMP) production platform.
WINNER | Caliber Biotherapeutics
CATEGORY| Process Innovation
FACILITY | Bryan, TX
PLANT MANAGER | Lan Ly
The Caliber Biotherapeutics manufacturing facil- ity in Bryan, Texas offers an interesting look at he development and integration of Plant Made Pharmaceuticals. This commitment to new and
innovative drug development strategies has led to it being
recognized as one of Pharmaceutical Processing’s Facility
Excellence Award winners for 2014.
The Caliber facility provides 128,000 square feet for growing up to 2. 2 million Nicotiana benthamiana plants, and
came into being as the result of a Technology Investment
Agreement between the Defense Advanced Research Projects
Agency (DARPA) and Caliber’s parent company, G-Con.
The agreement was part of Project Blue Angel, an H1N1
acceleration project designed to show that Plant Made
Pharmaceuticals (PMP) can be scaled-up to deliver biothera-
peutic proteins at a lower cost. While there is already strong
research data supporting the use of plant-based technology,
this project represented the first in which production levels
were scaled-up to support military and government needs.
The facility began initial production in late 2011, with the
goals of proving that a plant-based system offers the advantages
(compared to mammalian cell systems) of higher throughput development and screening of monoclonals and easier manipulation of primary amino acid sequence and glycosylation patterns.
The hydroponic plant production system begins with
pre-soaking rockwool Kiem plugs and placing them in
240-count Styrofoam trays with a pH-adjusted hydroponic
nutrient solution. Following this procedure, seed is distributed via a Bouldin & Lawson compact needle seeder. After
three weeks plants are transplanted into grow trays and
placed on flow racks. These trays are loaded and unloaded
by custom-built wire-guided forklifts.
The Styrofoam trays are then placed in a specially-de-signed aluminum germination flat that, when fitted with drip
irrigation, delivers a re-circulating hydroponic solution of
growth nutrients. Germination trays are then placed in a
room where a laminar flow wall disburses air at a constant
temperature of 27 degrees Celsius and relative humidity of
approximately 50 percent. Under these conditions, germination typically occurs within 3-5 days, with plants remaining
in the germination room for 21 days.
Fully developed plugs are then transplanted to grow trays
that are fitted with a vacuum infiltration lid. The plants reach
their optimum size in approximately seven days. LED lighting
is used throughout the facility instead of standard fluorescent
lights because fluorescent lighting proved to require more
maintenance, produced too much heat and could not deliver
■ 14 MARCH 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM