Success Factor Containment Safe Contract Manufacturing With Zero Contamination

Author / Editor: Axel Friese* / Anke Geipel-Kern

Contract manufacturers are working with challenging customers and require highly sophisticated equipment. CordenPharma is now going the extra mile. With the construction of a new, fully-contained development lab for high potency compounds, covering all manufacturing process steps for the development and production of tablets, the company is able to achieve unequaled OEL (Operator Exposure Limit) levels of less than 1 µg/m³. This is the first step towards zero contamination.

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(Source: Glatt)

The demand for the formulation of highly potent compounds, especially for cancer treatment, remains high, not only for parenterals but also for oral solid dosage. There is a high need for the manufacture of highly potent oral solid dosage forms. Some estimate that oral oncology drugs have doubled in the past ten years.

Corden Pharma is a full-service Contract Development & Manufacturing Organization for APIs (Active Pharmaceutical Ingredients), Drug Products & Packaging in the global pharma and biotechnology industry. At the Corden Pharma Plankstadt facility near Frankfurt, Germany, their services are geared towards the formulation, development and manufacturing of oral oncology drugs under the company’s Highly Potent & Oncology technology platform.

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A Brand New Development Lab

In 2016, Corden Pharma made the decision to construct a brand new development lab for highly potent compounds in Corden Pharma Plankstadt. By making this investment, Corden Pharma wasn’t only looking to expand capacity, but more importantly to extend their capabilities and increase flexibility during early development, requiring only small quantities of API. This in turn allows for work without full GMP requirements and change over procedures, as well as provides full safety protection and data availability during small-scale investigations.

Jason Bertola, Director, Global Highly Potent & Oncology Platform Corden Pharma
Jason Bertola, Director, Global Highly Potent & Oncology Platform Corden Pharma
(Source: Corden Pharma International)

Corden Pharma needed a technical solution which offered safe highly potent contract manufacturing with appropriate engineering controls to ensure effective protection across all OEL levels, while also providing their customers with highly flexible and efficient production methods.

Corden Pharma Plankstadt has used Glatt equipment in the production and development of highly potent substances for 20 years. In 2016 they decided to work with Glatt once again, appreciating their professional, customer-orientated approach to business and the technical excellence of their equipment and engineering. In addition, they chose Glatt equipment because it represented the best technological fit, while also adding significant flexibility to Corden Pharma’s development capabilities.