MannKind Corporation is a bio-pharmaceutical firm located in the city of Santa Clarita, California, in the US. It works on the discovery, development and commercialisation of drugs used to treat diseases such as diabetes and cancer.
Afrezza, a rapid-acting insulin therapy being developed for the control of hyperglycemia in adults with type one or type two diabetes, is the company’s lead product candidate. MKC1106 and MKC204 are two other products being developed for the treatment of different types of cancer.
Afrezza requires unique a formulation and drug delivery system. The production process is so specialised that no existing manufacturing facility was capable of producing it. The company designed and built its own manufacturing facility in Danbury, Connecticut, for commercialisation of Afrezza.
The Afrezza manufacturing facility required an investment of $163m. It was dedicated in September 2008.
In January 2010, the plant won two Facility of the Year Awards (FOYA), one for Process Innovation and another for Equipment Innovation. FOYA is sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing Magazine. It is given each year to honour and recognise the best of pharmaceutical manufacturing facilities in seven different categories.
Connecticut’s Danbury Afrezza manufacturing plant construction
The Danbury project broke ground in early 2007 and was completed in the second half of 2008. The plant has a total floor space of around 23,400 square metres.
The project was part renovation and part new construction. Approximately 20% of the facility is apportioned to facilitate future expansion, which can be undertaken to increase production of insulin therapy or start production of new Technosphere-based products.
Renovations were undertaken within the same building as the company’s ongoing clinical manufacturing suite. New manufacturing operations were accommodated by renovating about 6,503 square metres of the existing space and an attached central utility plant was also upgraded.
New construction work involved the addition of 16,723 square metres to the plant. This phase of work involved installation of two fill and two packaging suites with associated support rooms. Each of these suites can accommodate three fill / packaging lines.
The new building houses 882 square metres of material and product storage space, most of which is refrigerated. The total area of the second floor of the new building is outfitted for operations such as offices, meeting, dining and support.
Unique manufacturing processes for MannKind’s rapid-acting insulin therapy
MannKind’s Afrezza production plant has an advanced, custom manufacturing process line from beginning to end.
The first stage in the process is the creation of the Technosphere(R) particle. The particle is mixed with insulin in a specialty mixer, after which the mixture is frozen to separate the powder. The dried powder is shifted to fillers, where it is then filled into capsules and packaged.
Features and facilities of the award-winning insulin production facility
In order to meet the unique production needs, new technology was designed and innovative adaptations were applied to the existing technology.
One such innovative adaptation was made to specialty reactor which is used to blend Technosphere particles with insulin.
The plant has a high speed filling system and applies a cost-effective mode of moving bulk powder from the lyophilizer to the filler.
A recognising feature of the facility is the first-ever pharmaceutical adaptation of a cryopelletizer in solid-dosage form. The modified cryopelletiser produces uniform pellets. During the bulk lyophilisation process, water from the uniform pellets can be removed quickly in a systematic manner.
Central utilities comprise a steam boiler system. There is also a chill plant with a primary / secondary pumping system.
In order to support the Central Utility Building and keep the facility working, even during a power failure, the plant is equipped with a new 2,500kW substation and emergency generator.
Key contractors and suppliers involved with MannKind’s Afrezza plant
Philadelphia-based KlingStubbins was the architect of the inhalable dosage manufacturing facility. Clark, Richardson & Biskup Consulting Engineers (CRB) of Plymouth Meeting, Pennsylvania, was the prime consultant for architectural and engineering design. Construction manager for the plant was Torcon, a construction management and general contracting services provider based in New Jersey.
Automated Control Concepts (New Jersey), Dynamic Systems (North Carolina), Cryogenic Equipment Systems (Belgium), Integrated Process Technologies (Massachusetts), Serail (France) and Siemens Building Technologies (New Jersey) were some of the major suppliers.