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New Highly Potent Lab Increases Flexibility, Scale-up

Nov 14, 2017
Article > Success Factor - Containment: Glatt & CordenPharma

Article > Success Factor – Containment: Glatt & CordenPharma

by Axel Friese, Head of Marketing, Glatt GmbH & Jason Bertola, Director, Highly Potent & Oncology Platform

Process Worldwide, June 2017

A recent article covering CordenPharma Plankstadt’s new, fully-contained development lab for highly potent compounds utilizing Glatt’s containment solutions.

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. CordenPharma 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 CordenPharma 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. In 2016, CordenPharma made the decision to construct a brand new development lab for highly potent compounds in CordenPharma Plankstadt. By making this investment, CordenPharma 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.

CordenPharma 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 CordenPharma’s development capabilities.

Challenging Markets

Evolving markets and more stringent regulatory requirements demand flexible solutions. This means that, during the development phase, questions are raised as to whether a containment system can keep up with demands Glatt’s equipment completes CordenPharma’s offering by adding small-scale processing capabilities (i.e. 10g to 1Kg) for the initial technical batches, allowing the pharmacists to work on early development projects with limited available toxicological information, and subsequently following the process through its development lifecycle and scale-up to support all activities related to development and commercial manufacturing in one facility, all while using the same or similar type of equipment technology, full data availability and process.

Three Questions to Jason Bertola, Director, Global Highly Potent & Oncology Platform, CordenPharma International

What were the key reasons for making this investment?

BERTOLA : CordenPharma’s services at our CordenPharma Plankstadt facility focus on the production of highly potent oral solid dosage compounds under our Highly Potent & Oncology Technology Platform. This investment not only expands our capacity but, more importantly, expands our capability and speed to react to customer inquiries. The investment further completes our full-service offering by following processes through their development lifecycle and scale-up to final commercial product.

What finally led to the decision to go with Glatt?

BERTOLA : Glatt’s solution represents the best technology fit and engineering controls for our business, with the additional benefit of adding significant flexibility to our development capabilities.

What are the technical advantages of Glatt’s solution?

BERTOLA : Glatt’s solution allows for initial formulation studies to take place quickly, in an environment with strict engineering controls and limited use of Active Pharmaceutical Ingredients (APIs). The restricted access barrier system (RABS) protects the operator, the product and the environment. It also allows several process steps to be performed concurrently.

Strong Partnership

Corden Pharma’s expertise in the production of highly potent APIs and Drug Products is derived from decades of experience, the systematic application of new technologies and scientific learning, a risk-based approach as part of their Quality by Design (QbD)-driven development strategy, and their Glatt Lab Containment Technology.

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