Who’s Developing Your Process?

Once upon a time in the pharma industry everything revolved around small molecules. Small molecules are manufactured by chemical engineers and overall, the compound can be well characterized and the structure analyzed with a high degree of precision. Though this isn’t a simple task, people who are skilled in the art can design and control the production so that it meets industrial manufacturing requirements.

But in the 1980s, biopharmaceutical molecules burst onto the market, and added a whole new layer of complexity. Biologics are not nearly so easy to develop and manufacture, and require expertise in biochemistry, microbiology and molecular biology. Living organisms do not always behave as we want them to, when we want them to. Potential problems abound; the amount of product might be tiny or unwanted compounds (sometimes toxic) might be produced. Most companies weren’t equipped to deal with these new types of products. Some started to build new capabilities in house, but many looked to contract manufacturing organization to do it instead. Companies that didn’t build their own facilities also didn’t build their own in-house know-how and expertise for working with biopharmaceuticals.

Outsourcing is not inherently bad, of course, and has many advantages, but it can mean that process development is sometimes rather neglected. In my view, there isn’t much interest in being a pharmaceutical company that researches, develops and manufactures all of its own products in-house in today’s industry. Instead, every company has their own strengths. Big pharma excels at commercial manufacturing, marketing and selling, and is less adept at research and process development. Small companies often focus on research, hoping to sell their fledgling products on to big pharma once proof of concept has been demonstrated.

These small companies don’t have the money or resources to do the process development either. Some medium-size companies do have process development in-house, but those companies also tend to have many projects on-the-go at once. It’s difficult to be an expert in process development for all of your products, which poses a problem as many big pharma companies now refuse to buy an investigational drug until the process development has been completed. Biotechs with a great idea but limited process development can increasingly expect to hear statements such as, “We like your project. Come back to us when you have a good process for it and then we’ll buy it.”

So who is going to do the process development? Most will turn to a contract manufacturing organization (CMO). It is at this point that the lack of in-house knowledge can create a few problems. When a project is outsourced, it’s up to the customer to give the CMO clear guidance on expectations and outcomes. If you lack process development expertise, that communication can be difficult since you may not know what you want or what you’ll need to sell the idea to big pharma. And when the CMO develops the process, it may be difficult to assess its suitability. One way to overcome these issues is to hire a consultant, who can bridge the knowledge gap and make sure that you get what you need.

It’s tempting to push CMOs for the lowest price. But when people try to save money, they often cut corners. You may find that an underpaid CMO doesn’t do all the activity that is really needed to develop a well-controlled process. Indeed, you may end up with a process that will work on a good day but not a normal day – let alone a bad one.

Even though there have been enormous improvements in analytical tools for biomolecules, their accuracy is not comparable to that of small molecules and there are many things that can go wrong in biotech development and production. If you don’t have the expertise in-house then you must take help from someone who does. But please be warned – do not cut corners. Choose CMOs and consultants who you trust to give you honest advice, not just the lowest price. Whether you outsource or build expertise in-house, it is crucial to invest in process development if you want to give your product – and your business – the best chance to of success.