Three pitfalls to avoid in drug development partnerships

Thinking about outsourcing your API production to a contract development and manufacturing organization? Ask these three questions first.

By Nina Notman, C&EN BrandLab Contributing Writer

When a new drug hits the shelves of a pharmacy, it signals the culmination of the complicated, long, and expensive business of drug development. To lighten the load of creating new drugs, pharmaceutical companies are increasingly seeking contract development and manufacturing organizations (CDMOs) to assist with every element of taking a molecule from the hands of a scientist to those of a patient. The right partner can offer access to specialist technologies, improve efficiencies, and guide drugs seamlessly through ever more stringent government regulations.


The synthesis of a drug’s biologically active component—the active pharmaceutical ingredient, or API—is the most frequently outsourced part of drug manufacturing. A recent Transparency Market Research report valued the global API market at $134.7 billion in 2015, with a projected increase to $219.6 billion by 2023.


Although outsourcing API production to a CDMO has benefits, it can also be a Pandora's box: Choosing the wrong CDMO can lead to significant delays and elevated costs. Here are three common pitfalls pharmaceutical companies need to be wary of when choosing a CDMO:

1) Can the CDMO comply with regulations?

Top of the list when selecting a CDMO should be the company’s ability to comply with government regulations in the countries where the drug will be tested and, ultimately, sold. Information on a company’s past performance can be requested from regulatory bodies such as the U.S. Food & Drug Administration and the European Medicines Agency.


“Regulatory hurdles have increased over the last few years,” explains Craig Dixon, senior business manager at Patheon, part of Thermo Fisher Scientific. Improved analytical methods have made it possible to spot impurities at lower levels than ever. Regulatory bodies now demand additional data, using these new techniques, and a deeper understanding of quality to demonstrate that products are safe for patients.


The number of inspections by the U.S. Food & Drug Administration at overseas API-producing facilities has also skyrocketed, resulting in an increasing number of foreign companies being temporarily banned from importing APIs into the U.S. This trend started after 2007 and 2008 when a supplier in China tampered with an API used to make the anticoagulant drug heparin. This adulteration was linked to 81 deaths in the U.S.

2) Can the CDMO navigate the patent process?

Navigating the patent process is much easier with the right CDMO. An ethos of robust science and impeccable record keeping is vital for ensuring patents can be obtained on any new chemistry developed for manufacturing an API. A missed opportunity by a CDMO can equal a substantial loss of potential income.


Equally important is ensuring the synthetic route to an API isn’t infringing a patent. “If you're infringing on someone’s patent, it's going to cost a lot of money to sort out,” says James Bruno, owner of the New Jersey-based consulting firm Chemical & Pharmaceutical Solutions.


Delays caused by patent infringements also reduce a drug’s potential income. “You've got a limited amount of patent exclusivity,” Bruno explains.

3) Does the CDMO offer room to grow?

The need to switch API producers as a drug moves through clinical trials to market also costs dearly. “You don't really want to go to somebody at the start who's not going to be able to handle this product for its whole life cycle,” Bruno says. “It's a regulatory nightmare and you’ve got to transfer the technical process. Things go wrong when you're doing that.”


Patheon's Dixon agrees. “Many of our customers have transferred in from other CDMOs—usually because they have run into issues relating to capacity constraints or the regulatory experience required to advance their project along the clinical trial path,” he says. “Transferring a project from one CDMO to another costs time and money. They probably end up paying more than they would if they'd come to Patheon from the start.”

Learn more about partnering with Patheon by downloading our whitepaper,
"What You Need to Know to Avoid Costly Delays in Your API Scale-Up."