Dr. Stephen Houldsworth Highlights Extensive Small Molecule Investments for Drug Substance and Drug Products

Dr. Stephen Houldsworth, Sr. VP, Global Head of Small Molecules Platform speaks with 24/7 BioPharma on CordenPharma’s expansions across small molecule drug substance and drug product outsourcing.

Recent investments in Small Molecule Drug Substance:

• In our CordenPharma Liestal (CH) facility we are wrapping up a 5-year facility renovation with increased capacity in purification and small-scale development capabilities.
• At our CordenPharma Chenôve (FR) site, we’ve expanded by adding new 6,000 Liter reactors and manufacturing trains with isolation and drying capacity.
• For our CordenPharma Bergamo (IT) facility, we made significant infrastructure investments in warehousing space to meet the increased supply demand, as well as a new CDMO line with 8,000 Liter capacity, including additional hydrogenation and isolation capabilities.

For Small Molecule Drug Products, we have increased the breadth of our offerings by focusing on:

• The completion of extensive investments in our CordenPharma Plankstadt (DE) facility, including a new Oral Solid Dosage (OSD) medium-scale manufacturing line that bridges the gap between small and large-scale capacities already in place to help innovators grow their clinical programs.
• New technologies at our CordenPharma Lisbon (PT) facility, including roller compactors and tablet coaters.
• Additional filling lines for oral liquids at our CordenPharma Fribourg (CH) site.

In terms of true end-to-end supply services, our new oral peptide manufacturing capability, which services a rapidly expanding area of the GLP-1 market, plays perfectly into our product offerings. For peptide synthesis, we have massive manufacturing capacity, which typically leads to the injectable drug product market, but our new innovations in bioavailability enabled us to segway into oral peptide delivery.

A good application of this new technology is our recent Press Release announcing our partnership with Viking Therapeutics to manufacture its Dual GLP-1/GIP Receptor Agonist peptide API, 200 million units of sterile injectables (including PFS, vials, and auto-injectors) and 1 billion units of oral solid tablets for its subcutaneous and oral peptide formulations respectively.

Here, Viking have taken advantage of our ability to develop and scale up oral formulations to deliver innovative peptides to their patients in a more user-friendly format. With fully-available capacity for tableting at our Plankstadt (DE), Fribourg (CH) and Lisbon (PT) facilities, we can draw upon our network of integrated facilities to meet the demand.

Staying at the forefront of small molecule innovation is critical at CordenPharma. Right now, we are particularly focused on our Centre of Excellence for Solid-State and Polymorphism in Liestal (CH), where we not only help innovators create intellectual property around the solid forms of their APIs, but also solve critical challenges they often face with stability, solubility and delivery of APIs to patients.

Our Centre of Excellence for Flow Chemistry in Chenôve (FR) allows customers to take advantage of flow chemistry technology for outsourcing of projects that are not amenable from a batch point of view – for example electrochemistry or photochemistry – to produce a wider range of molecules.

Stephen comments, “Our extensive expansions in both small molecule drug substance and drug product capacity, combined with innovative technologies for bioavailability and solid-state considerations for early-phase projects and a global network of robust facilities across six platforms, provides increased flexibility and value for small molecule therapeutics across innovators’ full drug lifecycle.”