Pharma Outsourcing

CONVENTIONAL pharmaceutical wisdom has it that the world is divided into small and large molecules. On the one hand are the traditional small molecules discovered by medicinal chemists and commercially manufactured in complex multistep syntheses. On the other hand are proteins and other biologic materials expressed whole by bacteria or mammalian cells that grow in big stainless steel fermenters.

The reality is that pharmaceutical researchers come up with an astonishing variety of therapeutic compounds that are small, large, and everything in between. Many of these molecules don't fit into either of the neat categories that the conventional wisdom calls for.

When researchers work for a small biotechnology company, they and their colleagues rarely have the skills needed to manufacture their compounds at large scale and to the standards expected by regulatory agencies. That's where custom pharmaceutical manufacturers come in. These versatile companies must be prepared to produce myriad molecules thrown at them by drug discoverers of all types.

In the pages that follow, C&EN presents three case studies of the relationship between a custom manufacturer and a biotech firm. In the first article, the compound being developed is a therapeutic polymer, a large molecule but certainly not a protein.

The compound in the second story is an oligonucleotide, a midsized molecule made of a chain of the nucleotides found in every human cell. Oligonucleotides are at the heart of the RNA-type drugs that are making a splash in the scientific world, but they have yet to find commercial success. In the third story, the therapeutic agent is a combination of an antibody and an enzyme, skillfully connected by a conjugating molecule.

None of these drugs has made it to market, and chances are good that none of them will. But the outsourcing partnerships that have brought them out of the laboratory and into the testing phase demonstrate the power of chemistry to synthesize an endless variety of active pharmaceutical ingredients.

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