Avista Pharma Solutions expands Drug Product cGMP Manufacturing at Colorado Site
Avista Pharma Solutions has completed extensive facility upgrades at its Longmont, Colorado site, expanding its drug product manufacturing footprint by approximately 20,000 square feet and allowing for the formulation and manufacture of new dosage forms. The expansion includes four new, state-of-the-art cGMP processing suites and all associated manufacturing support areas. These upgrades demonstrate Avista Pharma’s commitment to delivering comprehensive, timely and reliable service for all clients, regardless of their product’s stage in the development lifecycle.
Avista Pharma’s drug product capabilities now include encapsulation; high-shear granulation; fluid-bed granulation, drying and Wurster coating; tablet compression; tablet coating; and packaging. In addition, Avista Pharma’s drug product operations team now supports the formulation and manufacture of the following dosage forms:
– Immediate-release tablets and capsules
– Enteric-release tablets
– Modified-release, multi-particulate tablets and capsules
– Hydrophilic and hydrophobic matrix extended-released tablets
– Opiate tamper-resistant, modified-release tablets (using a surrogate drug)
– Coated aqueous insoluble active ingredients
Complete with 24-hour environmental monitoring, the new manufacturing suites are designed and monitored to ISO 7 requirements. The expanded manufacturing support areas meet ISO 8 requirements and include a wash and prep area, as well as clean equipment storage. The facility will also include a new purified water system, walk-in stability storage chambers and a temperature-controlled warehouse containing refrigerated storage locations.
“Expanding our drug product capabilities enables us to better serve our clients as a trusted, effective and innovative partner in all phases of the drug development lifecycle,” said Ken Domagalski, General Manager of the Longmont facility. “By offering optimized formulation and manufacturing of a wider range of dosage forms, we can now help make more life preserving medicines a reality.”
As part of Avista Pharma’s ongoing efforts to offer clients the most efficient path to success, the company made several significant investments in Longmont throughout 2017. In addition to strengthening its drug product operations, Avista Pharma recently doubled the site’s API manufacturing capacity.