Small Molecule Platform Expands Development

Edition 3 / March 2019
Small Molecules Platform > New Small Molecule Platform Centre of Excellence Transforms Process Development

Edition 3 / March 2019

CordenPharma’s Dr. Stephen Houldsworth, Director, Global Small Molecules & Antibiotics Platforms headshot

Author
Dr. Stephen Houldsworth

Director, Global Small Molecules & Antibiotics Platforms
CordenPharma International


New Small Molecule Platform Centre of Excellence Transforms Process Development

CordenPharma Process chemist setting up automated equipment to perform DoE experiments in CordenPharma Switzerland

Process chemist setting up automated equipment to perform DoE experiments in CordenPharma Switzerland.

The heart of CordenPharma’s Small Molecule Platform remains our API manufacturing history and capacity. With an integrated network of facilities bringing a combined 200+ years of manufacturing experience to bear on your project and over 1.2 million Liters of volumetric capacity ranging from 20 L to 28,000 L reactors of various materials of construction, CordenPharma most importantly provides the expertise necessary to tailor scale-able manufacturing processes which drive the lifecycle of your drug development project.

Today we find the majority of our customers have in-house discovery / medicinal chemistry resources but lack the process / industrialization experience required to create and scale-up manufacturing processes that are safe and cost-effective. With this in mind, CordenPharma’s Leadership Team determined that we needed to invest in our own development resources in order to further augment our offering of these essential services to customers.

Located just outside of Basel in Liestal, Switzerland, our CordenPharma Switzerland facility is a former Genzyme Pharmaceuticals manufacturing site that was acquired by our parent company International Chemical Investors Group (ICIG) in 2011. Since then it has played a key role in transforming the Small Molecule Platform by becoming the new CordenPharma Small Molecule Centre of Excellence.

While its repertoire of smaller scale reactors has made it an ideal manufacturing center for early-phase clinical customers, it also provides commercial manufacturing opportunities for customers with niche / orphan product offerings requiring sub-metric ton annual quantities. With a track record of over 25 years in the pharma industry, the site became the early entry point for many customers into our Small Molecules Platform, which naturally made it the logical next step in our small molecule development investment strategy. This new process development hub has seen an expansion of laboratory space, a significant investment in automated development and optimization equipment, and an extensive upgrade of analytical equipment.

A secondary, but just as critical, aspect of this creation is the expansion of our small-scale manufacturing capabilities. This area of the investment includes the construction of a new mini-plant intended to meet the growing market demands in the g to kg range at a scale of 1 – 70 Liters. The new design, with movable and interchangeable equipment, will create a highly flexible manufacturing space geared towards meeting our customers’ wide ranging requirements and aggressive timelines. The combination of these two aspects will enable us to accelerate their programs into initial clinical phases of development.

The group in Liestal will now focus solely on creating robust, scalable processes starting from the customer’s medicinal chemistry route. Once developed, the initial small-scale manufacturing runs to produce kilo-scale lots will occur in our manufacturing area to provide seamless initial transition from development to manufacturing and clinical supply. Throughout the development process, CordenPharma Switzerland’s Quality group will be involved every step of the way to ensure that phase-appropriate validation and documentation is in place for a smooth regulatory pathway, along with the necessary regulatory support for CMC document preparation.

As programs evolve and advance and your quantity requirements increase, we can then perform an internal process transfer to one of our larger scale manufacturing facilities to provide you with late-stage clinical and commercial demands and stage-appropriate validation support.


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