The US-based firm has recently ramped up both capacity and capabilities at its existing plant in New Jersey, company spokesperson Thomas Salus told Outsourcing-Pharma.com during the show.
Glatt has added new good manufacturing practice (GMP)-certified clinical trial and commercial scale manufacturing equipment - a fluid bed granulator/dryer for 30-250kg batches and a high shear granulator for 75-180kg batches - in order to improve its production of controlled-release solid dosage forms by using organic solvent processing (with acetone, methanol, ethanol and isopropanol (IPA) alcohol).
"We can now use organic solvents in the manufacturing process, which brings advantages when making controlled-release drugs because the polymers usually work better in processes that use organic- rather than aqueous-based solvents. The organic-based process is also more flexible," said Salus.
In addition, the firm is now in the process of installing and qualifying new development and pilot plant equipment - a fluid bed granulator/dryer for 1.5-15kg batches and one for 300-5,000g batches; a tablet press; and an encapsulator for hard gelatine filling of powders, pellets and tablets in capsule size 00 to 4 - which will allow it to also begin producing small batches of controlled-release drugs using organic solvent processes.
Within the New Jersey plant, Glatt has also added a new analytical laboratory, with equipment allowing High Performance Liquid Chromatography (HPLC), gas chromatography (GC), and dissolution, in order to provide the necessary testing to support the product development of the controlled release dosages manufactured at the site.
"We previously had limited capacity to do this but the new laboratory has allowed us to double our capacity," said Salus.
"Controlled-release dosage forms are our area of expertise and we are increasingly focusing our resources in this area."
Controlled-release drugs are also a growing area, as more pharmaceutical companies are beginning to focus on improved forms of drug delivery as an integral component of drug development, not just as part of a drug's life cycle management.
The technology can be used in order to develop tailor-made drug delivery systems, resulting in the development of more effective and convenient therapies for the patient by simplifying and reducing the frequency of the delivery of medications, reducing side effects and increasing therapeutic success.
Meanwhile, as part of the site expansion, Glatt said it is also in the final stages of constructing a new controlled substance vault to store "large quantities" of controlled chemicals for use in commercial production.
