When to Use Outsourcing in Drug Development

The process of bringing a new drug to market can be lengthy, requiring significant R&D, specialized manufacturing equipment, and the expertise to navigate regulatory concerns. Companies are increasingly outsourcing pharmaceutical development, bringing in CMO pharmaceutical companies to help manage their drugs.

Whether you are in clinical trials and looking to scale-up, need a particular type of technology, or are simply switching your contract drug development partner, outsourcing in drug development requires selecting the right manufacturing partner.

WHY OUTSOURCE MANUFACTURING TO CMO PHARMACEUTICAL COMPANIES?
 

Drug development and manufacturing can present serious challenges to pharmaceutical process development and budgets. Pharmaceutical manufacturing costs are high, and you may not have the in-house capabilities to develop, manufacture, and scale-up your drug. Working with CMO pharmaceutical companies can help avoid some of these costly start-up expenses.

Access to specialized equipment is another major benefit. If you know that you will need time on a fermenter or access to a Gerteis roller compactor, outsourcing pharmaceutical development may be a good option.

In addition to accessing technology and reducing overall costs, an effective drug development partner will have scientific and regulatory expertise that can ease common challenges often seen with third party manufacturing. Pharma companies with their own process for drug development are able to guide partners through unforeseen challenges, and are well-versed in commercialization and scale-up as a result of experience with their own products.

All of these considerations can accelerate time to market and aid scale-up. The benefits for outsourcing in drug development is impressive:

  • Reduction of start-up costs
  • Use of specialized equipment
  • Access to technical and regulatory expertise
  • Accelerate time to market
  • Navigate commercialization processes with an experienced partner

WHAT ARE YOUR CONTRACT DRUG DEVELOPMENT NEEDS?
 

The decision to work with third party manufacturing pharma companies is quickly followed by a question: which company should you work with?

The answer will depend on the specifics of your drug and existing capabilities.

What kind of drug are you producing, and what is the market size? The class of drug will dictate technology and technical expertise required for effective development and third party manufacturing. Pharma companies as CMOs sometimes have specific capacity available, so market size is significant in helping you to assess your requirements and choose a partner with the space you need. The ideal contract manufacturing partner will be able to support you from clinical through to commercial scale.

What in-house capabilities do you already have? Depending on your needs, you may be looking for a complete manufacturing and development solution, or else seeking out a tactical partner to help you fill gaps in your capabilities. The phase of your drug is also relevant; your needs in a manufacturing partner may be different during clinical trials and commercialization.

You do not want to select a CMO only to discover that they don’t have the capabilities you require. Knowing your outsourcing needs and timeline up front allows faster identification of contract manufacturing organizations that can work on your project.

HOW DO YOU ENGAGE WITH A CMO?
 

With your needs clearly established, you can begin evaluating individual contract manufacturing partners.

Of course, you need a partner that can meet your specific manufacturing needs and challenges. But it is also beneficial to enlist one with a breadth of experience. A partner with experience producing a variety of drugs at clinical and commercial scale will be better able to address unforeseen challenges with unique solutions. When combined with technical, regulatory and project management expertise, this experience will ensure smooth pharmaceutical process development and manufacturing transitions.

When approaching CMO pharmaceutical companies, know what kind of relationship you are looking for. You may simply need access to a particular piece of equipment, with the capability to complete the rest of your manufacturing in-house. On the other hand, you may be looking for a long-term strategic partner that can help with the entire process of bringing a new drug to market, from development to clinical trial to commercialization and scale-up.

If you’ve found a CMO that seems like a good fit, reach out over the phone or via their online contact form to set up an initial presentation. They’ll work with you to figure out the best outsourcing solution for your project.

Whichever partnership you pursue, a reliable CMO with state-of-the-art capabilities and advanced scientific expertise is key. Learn more about AbbVie Contract Manufacturing to find out what a CMO partnership can do for your business.