Flexible Supply, Robust Industrial Hygiene For HPAPIs

Edition 1 / September 2018
Highly Potent & Oncology Platform > Shifting Oncology Drug Landscape Requires Flexible Supply Options

Edition 1 / September 2018

CordenPharma International Technology Platform Directors - Jason Bertola, Director, Global Highly Potent & Oncology Platform

Author
Jason Bertola

Director, Global Highly Potent & Oncology Platform,
CordenPharma International


Shifting Oncology Drug Landscape Requires Flexible Supply Options

CordenPharma technician working in glovebox for manufacturing highly potent oral solid dosage forms

Manufacturing of Highly Potent Oral Solid Dosage Forms at CordenPharma

Oncology drug development has changed significantly in the past 20 years. Patient segmentation based on specific biomarkers led to specific treatment or treatment options. Also, the speed of innovation created more competition – with 80% of the compounds developed having at least one competitor in the pipeline1 – coupled with improved diagnostic techniques, which resulted in better standard of care, longer life expectancy, smaller volumes of products and shorter lifecycles for new products.

This shift, along with more stringent regulatory requirements, has not only driven cancer care forward but also placed new challenges on innovators and their manufacturing facilities or CDMOs. Now, manufacturers deal with more complex drugs and, by extension, more challenging production workflows, shorter timelines to market and more intense competition due to shorter product lifecycle.

To help meet the needs in this changing landscape, CordenPharma has assembled a wealth of experience (over 26 years) and expertise organized under the Highly Potent & Oncology Platform for the development and manufacturing of oncology drugs, with a focus on highly potent compounds.

Our two facilities in Boulder, Colorado, US (CordenPharma Colorado & CordenPharma Boulder) have approximately 300 employees. They focus on the development and manufacturing of Highly Potent APIs from laboratory scale to commercialization for all potencies, including picogram level. This is possible due to a series of engineering controls and a well-defined, robust, industrial hygiene program. API services include traditional highly potent small molecules and peptides (solution & solid phase) at all scales, as well as extensive purification expertise and highly potent chromatography.

CordenPharma Plankstadt, conveniently located one hour from Frankfurt (DE), has a broad range of capabilities and specializes in the development and manufacturing of Highly Potent Oral Solid Dose forms. In late 2017, a new development area was inaugurated allowing for the production of compounds with various potencies and degrees of containment in batches from 100 g to 1 Kg, with the appropriate engineering controls. All steps can be performed, starting from dispensing to film coating, in an engineering controlled environment protecting employees, product and environment. This extended CordenPharma’s capabilities from 100 g to 20 Kg for full commercial scale batch sizes.

CordenPharma Latina (IT) has extensive expertise in the manufacturing of Sterile Liquids and Lyophilized Vial cytotoxic and cytostatic products. The site, which offers technology transfer and manufacturing of aseptically filled vials for liquid and lyophilized vials, is comprised of two independent suites with two vial fill lines, both equipped with commercial scale lyophilization capabilities. The facility also includes one ampule line. The lines are equipped with barrier technology and dissolution vessels ranging from 50 L to 1,200 L.

All finished dosage facilities within the CordenPharma network meet the serialization compliance requirement aimed at combatting global counterfeiting. In addition, a team has been established to standardize processes, logistics and maintain the integrity of the data. All Corden Pharma facilities are routinely inspected by major regulatory agencies and regularly supply global regulated markets.

This continuum of capabilities from APIs to finished dosage, including ready-for-market packaging, labelling, and serialization, allows our customers to either pick and choose required services, or take advantage of our Integrated Supply chain by utilizing CordenPharma for both API and Drug Product production from development to commercialization. This level of integration is flexible and customizable, resulting in reduced complexity, de-risked supply chain and shorter lead-times enabling CordenPharma to deliver agile and innovative solutions to meet the current and future needs of our customers.

1 McKinsey & Company – McKinsey Cancer Center, The Next Wave of Innovation in Oncology Report 2016


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