Gannet BioChem

The major focus at Gannet BioChem is manufacturing custom polyethylene glycol (PEG) reagents to improve medications through a process called PEGylation. Occurring during downstream processing in pharmaceutical production, PEGylation attaches PEG chains to proteins, peptides, or small molecules in medications to improve their therapeutic profiles. From a patient perspective, PEGylated drugs improve immune system response with lower and less frequent doses. In short, PEGylated drugs allow doctors to prescribe better medications and enable better outcomes for their patients.

City with a changing identity

Before Huntsville became the research epicenter of the Apollo space program and earned the nickname “The Rocket City,” the town was best known as the Watercress Capital of the World. Millions of bunches of the peppery leaves — the healthiest vegetable on Earth — departed the famous Huntsville Depot for the White House and major cities all over the world.

Huntsville Depot is a 4.5-acre biotech campus with 124,000 square feet of lab and manufacturing space.
Operations are Current Good Manufacturing Practices (cGMP) compliant, as enforced by the FDA¹, allowing them to develop and manufacture PEG reagents and custom polymer solutions at a commercial scale. This is Gannet BioChem, an emerging leader in creating materials for FDAapproved therapeutics.²

Humidification is mandatory and monitored

Units of measurement at Gannet BioChem are smaller and more precise than bunches. Mechanical balance scales in the research labs are calibrated to the thousandth of a gram. The scales are so sensitive that even static electricity would influence beam deflection and make readings unreliable. To prevent static electricity and the resulting inaccuracies, interlocked humidity sensors above the scales lock out the scales if humidity drops below 20% RH.

Humidification is also critical on the production side, where process development and manufacturing suites require RH
between 40 and 60 percent. In these spaces, the danger from static electricity is two-fold: A static spark could damage sensitive electronics or ignite volatile process vapors when they are released from reactor vessels after production runs.

“Gannet utilizes humidification for safety, equipment operations, and personnel comfort,” confirms Alex Mumblow, Director of Engineering for Gannet BioChem. “These three items are critical to keeping our operations moving forward in a safe and efficient manner.“

Humidifiers inside and outside of the buildings either running or ready

Humidification steam is produced on site with, at any given moment, two of the four GTS LX series gas-to-steam humidifiers (two are redundant) and seven Vaporstream® electric-resistive humidifiers. The GTS humidifiers operate in separate, climate-controlled outdoor enclosures on two rooftops, and the Vaporstream humidifiers are spread out in four mechanical rooms throughout the campus.

Tying the humidifiers together is ductwork and four air handling units, where several Rapid-sorb dispersion tube systems disperse steam for, at any given moment, up to seven process development and manufacturing suites.

An eighth suite, last used for distilling and purifying ethylene oxide, sits idle and decommissioned, a constant reminder that when Gannet BioChem deems the wholesale cost of a primary building block for PEG reagent production out
of line with market value, they make it themselves.

DriSteem and James M. Pleasants Company, DriSteem’s rep for Alabama and neighboring states, are proud to provide humidification control for a biotech company’s most critical processes as they develop and manufacture PEG reagents for therapeutics that save lives and improve the outlooks of millions of patients.

Sources

1.  Current Good Manufacturing Practice (cGMP) Regulations – https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practicecgmp-regulations
2.  Gannet BioChem – https://www.gannetbiochem.com/
3.  Glass-lined Reactors – https://www.gmmpfaudler.com/glass-lined-equipment-1/glass-lined-reactors