Efficient, Expert cGMP Small Molecules Production

Edition 1 / September 2018
Small Molecules Platform > Heart of Small Molecules Platform Is Experience, Capacity & Integrated Supply

Edition 1 / September 2018

CordenPharma Interntational Technology Platform Directors Stephen Houldswirth PHD Global Small Molecules Antibiotics Platforms

Author
Dr. Stephen Houldsworth

Director, Global Small Molecules & Antibiotics Platforms,
CordenPharma International


Heart of Small Molecules Platform Is Experience, Capacity & Integrated Supply

 CordenPharma Chenôve (FR) technician operating equipment during small molecule manufacturing

Small Molecules Manufacturing in CordenPharma Chenôve (FR)

Small molecules continue to be the cornerstone of pharmaceutical development, despite biologics taking the major headlines in the industry press over the last couple of years. It is indeed true that a significant percentage of R&D budgets at big pharma today is directed to the biologics arena, but despite this the fact remains that over half of all drugs currently in the clinical pipeline are small molecule developments. The focus has shifted from the blockbuster mega volume products to smaller niche products or orphan indications, with speed to market still remaining a key success factor in the industry.

With the exception of the major pharmaceutical companies, the vast majority of the companies developing products today do not have in-house manufacturing capacity and thus rely on the CDMOs (Contract Development & Manufacturing Organizations) for development and manufacturing support during the clinical and commercial phases of the project. As a result, this industry sector has seen and continues to see significant growth. We recognize that our customers have a choice with regards their preferred manufacturing partner so we strive to provide industry-leading quality standards via an open communication pathway – we are only successful when our customers are successful!

The heart of CordenPharma’s Small Molecules Platform remains our API manufacturing history and capacity. With an integrated network of cGMP facilities across Europe and the US, CordenPharma brings a combined 200+ years of manufacturing experience to bear on your project, with over 1,200,000 million liters of volumetric capacity ranging from 20 L to 28,000 L reactors constructed of various materials.

Just outside Basel, Switzerland, our CordenPharma Switzerland facility is a Centre of Excellence in Process Development focused on creating robust, scalable processes starting from your medicinal chemistry route. Once developed, the small scale manufacturing runs to produce kilo scale lots provide the initial transition from development to manufacturing and clinical supply. Once developed and the route has been proven in manufacturing, we can then perform an internal process transfer to one of our larger scale manufacturing facilities to supply long term clinical and commercial demands, as well as provide stage-appropriate validation support.

Already have a developed process and now looking for a manufacturing partner? Depending on your scale requirements and geographical supply preferences we will select one of our manufacturing facilities to perform a smooth technology transfer of your process into production. Our European API facilities are CordenPharma Chenôve (Dijon, France) or CordenPharma Bergamo (Trevilio, Italy) and in the US, CordenPharma Colorado (Boulder, Colorado). All CordenPharma sites are FDA and EMEA approved with a long history of successful regulatory audits. Each site has ongoing commercial supply to multiple markets around the world including the US, Europe and Japan.

Since time to market is critical, our clients often take advantage of our Integrated Supply options through our injectable site CordenPharma Caponago (IT) (for vials, ampoules and pre-filled syringes) or our solid oral solutions site CordenPharma Plankstadt (DE) (for tablets and capsules). Through our integrated supply solutions, you save both time and money along your path to commercial success.


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