DCAT Week ’17 Announcement Forum: CordenPharma Expands Oligonucletide API and Sterile Injectables Manufacturing CapacityBy
Mimoun Ayoub, PhD
Corden Pharma is expanding into oligonucleotide active pharmaceutical ingredient (API) manufacturing, which is supported by a growing clinical pipeline of more than 150 oligonucleotide clinical projects, outlined Mimoun Ayoub, PhD, Director, Global Peptides, Oligonucleotides, Lipids, Carbohydrates & Injectables Platforms, CordenPharma, at the DCAT Member Company Announcement Forum held Monday March 20 at DCAT Week ’17.
This pipeline includes approximately 75 Phase II projects and approximately 18 Phase III projects. Based on these commercial volume assumptions, CordenPharma has entered the oligonucleotide API manufacturing market by leveraging its existing capacity and expertise in developing and manufacturing large volumes of peptide APIs. The company currently works in the oligonucleotide field by developing and supplying synthetic lipids for oligonucleotide drug formulations by manufacturing various carbohydrates for oligonucleotide-targeted drug delivery and/or by providing oligonucleotide drug product manufacturing, packaging, and logistics for clinical trials.
The oligonucleotide API manufacturing investment is taking place in CordenPharma Colorado (US), where the infrastructure already exists for small- to large-scale manufacturing. The investment consists of additional manufacturing suites and equipment capable of producing tens of grams to more than 10-kg batches of oligonucleotides. A team of oligonucleotide experts has been hired to join existing personnel in overseeing the installation and production, with timelines of small- and medium-scale equipment to be running beginning in April 2017, and the largest oligonucleotide equipment targeted for GMP manufacturing before the end of 2017. CordenPharma‘s overall investment in the oligonucleotide manufacturing is more than $15 million for 2017.
Dr. Ayoub also announced that CordenPharma is increasing aseptic manufacturing capacity by adding two high-speed lines for prefilled syringes, cartridges, and vials. With filling volumes ranging from 1 mL to 20 mL, these two new lines will bring another 25 to 30 million units of capacity to the existing lines for a total of more than 120 million units per year. The lines will also use the latest technology (i.e.,ready-to-fill nest & tub). Furthermore, a large lyophilizer will be installed to produce sterile lyophilized products at large batches up to 25.000 vials per batch. CordenPharma’s injectable manufacturing investment, of more than EUR 14 million ($14.9 million), will take place in CordenPharma Caponago (IT) with targeted completion before the end of 2017.