Drug Discovery Alliances: Pioneers in API Manufacturing & Commercial Scale Production

Commercial API Manufacturing with Drug Discovery Alliances

Commercial API Manufacturing: Bridging Preclinical Development to Large-Scale Production

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 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. 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, DDA offers Oligonucleotide process development, scale-up and cGMP manufacturing at multiple scales, supporting early stage to Phase II / III.

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).

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.

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Deborah Minor

CEO at Drug Discovery Alliances

Deborah has decades of business development experience marketing contract services, drug licensing and new technologies to the pharmaceutical industry. She founded Drug Discovery Alliances, Inc. in 2001 to connect pharmaceutical and biotech companies with top industry contractors who facilitate and speed projects. Deborah earned a Ph.D. in Medicinal Chemistry from University of North Carolina, Chapel Hill and has worked as an organic chemist for Rhone Poulenc. She subsequently worked for Accelyrs and MDL, marketing molecular modeling technologies and databases including Beilstein and Crossfire to the pharmaceutical industry.