API Manufacturing of Small Molecules

DDA has an established API partner network providing capabilities that span from early preclinical to commercial API manufacturing. We work with our clients to understand the requirements of each project to ensure we match each program with the phase appropriate supplier which is based on process research requirements, chemistry requirements, volume requirements, phase of development, etc. Every supplier in the DDA network that manufactures commercial products has an excellent FDA Regulatory track record that our clients will see an expedited drug to market. We offer unrivaled expertise in synthesis, analytical and separation services to scale your active pharmaceutical ingredients (API) from initial process development to validation and commercial manufacturing.

Small Molecules Manufacturing

DDA provides a comprehensive solution supporting small molecule cGMP manufacturing spanning the entire development continuum from Phase 1 to Commercial Scale.

Oligonucleotide Manufacturing

Leveraging decades of experience in peptide manufacturing with the existing wide range of downstream capabilities at multiple facilities, offers Oligonucleotide process development, scale-up and cGMP manufacturing at multiple scales, supporting early stage to Phase II / III, (with commercial supply expected by the end of 2017).

  • Process Development & Small-scale > scale-up to 10 mmol per run (small-scale equipment can also support early-stage supply)
  • Scale-up and Small to Medium-scale > scale up to 60 mmol per run (supported by OligoPilot 400 equipment)
  • Oligonucleotide Process Equipment > allows fully-automated manufacturing at a scale-up to 1800 mmol per batch
  • Downstream Processing Capabilities > For each of the above mentioned process stages, multiple sets are available for streamlined and cost-effective manufacturing

Lipid Manufacturing

Expert in synthetic Lipid process development, scale-up and large scale manufacturing, including custom lipids and standard lipids (Glycero-Phospholipids, Sphingolipids, Cationic Lipids), for which CordenPharma holds several Drug Master Files (DMFs).

Carbohydrate Manufacturing

Extensive experience in complex Carbohydrate synthesis, including but not limited to Carbohydrate-based Vaccines and Carbohydrate Conjugates for Receptor Targeting (such as siRNA drug delivery to various tissues). Most of these complex building blocks are available from inventory, which allows for quick delivery.

Antibiotics

  • Dedicated facilities for segregated antibiotics.
  • Full-service offering and project management from API to final Drug Product, including packaging and labeling in globally approved facilities.
  • Oral & Sterile API & Drug Product solutions.

Fermentation

DDA provides contract development and manufacturing (CDMO) of microbial fermentation, technical enzymes and application of biocatalysis for the synthesis of intermediates and APIs. With fully controlled facilities, e.g. fermentation using Process Analytical Technology (PAT), CordenBioChem have expertise in development and large-scale production of immobilized enzymes using various carriers.