3 Steps to Choosing the Right Pharma Contract Manufacturing Organization

Joining forces with contract manufacturing organizations (CMOs) has become critical to success in the modern pharmaceutical industry. These pharma contract manufacturing partnerships allow companies to reduce overhead costs, scale faster, and focus more effort on core competencies. While there are significant, quantifiable benefits that come with CMO partnerships, it can be challenging to align your various CMOs with your organization’s quality standards and compliance demands.

Following the three recommendations outlined below will help you narrow down the field of potential pharma contract manufacturing partners so you can select a CMO that will help your company meet regulatory requirements, achieve business goals, and get high-quality products to market faster.

1. Ensure the Pharma CMO Has Modernized Manufacturing Execution System

If you’re considering a partnership with a CMO that hasn’t implemented modern, purpose-built contract manufacturing software, it’s unlikely that partner will be able to provide the speed, flexibility, and process optimization you can get from a CMO that has already initiated their digital transformation in manufacturing.

There are several causes for concern if you’re considering a CMO that’s still reliant on paper-based processes, specifically:

• Paper is inefficient and slows down every process in which it is used, which often leads to delays you can’t afford. For instance, if a post-production review is conducted line by line and page by page on paper, finished product may sit idle on the shop floor, unable to ship until the review is completed.
• Manual data entry and paper records are prone to error and inevitably lead to data integrity lapses that hinder compliance efforts. The U.S. Food and Drug Administration (FDA) and other regulatory bodies continue to increase their attention on pharma companies’ capacity to establish and maintain data integrity, and it plays a pivotal role in drug approval processes.¹
• Paper documentation and processes aren’t scalable, so they’ll hold you back when demand rises (more on that below).

Purpose-built contract manufacturing software can empower your CMOs to eliminate paper and avoid all the issues outlined above. A pharma contract manufacturing organization that uses a modern, digital, and connected manufacturing execution solution streamlines compliance activities and more closely aligns them with the expectations of regulators like the FDA. Such systems also help improve product quality because errors can be fixed faster (or avoided altogether), and they won’t affect other aspects of production. With digitally optimized production processes, you can deliver high-quality, compliant products to market sooner.

2. Ensure the CMO Provides Ample Visibility

Visibility is a pronounced concern in pharma contract manufacturing. An Accenture survey revealed that 60% of life sciences manufacturers struggle to get real-time inventory or manufacturing visibility, and nearly 40% said they lack control over product quality.² And while visibility is difficult to achieve and maintain, you should expect CMO partners to be prepared to provide it at any point during production.

Any pharma contract manufacturing organization you partner with should always have the following information readily available:

• Complete and accurate data demonstrating that they are meeting product requirements.
• Production status indicators that show exactly where the product is at any point in production.
• Expected/agreed upon delivery times.

Even though it’s most likely your CMOs will be geographically dispersed and not near your primary location, your data must be centralized. A proven contract manufacturing software solution will give stakeholders and decision-makers access to the most up-to-date information from anywhere in the world, at any time. To confirm that your production requirements are being met, your CMOs should use some form of specialized contract manufacturing software that allows them to quickly and comprehensively transfer relevant data that has been collected throughout production.

3. Make Certain the CMO Is Optimized for the Scalability You Need

When business is going well, pharma companies often need to scale up quickly to meet an increase in demand. In other instances, such as in growing fields like personalized medicine or cell and gene therapy, companies require the services of a CMO that can scale down to make small batches or a batch of one. It’s essential that you know whether your pharma contract manufacturing organization has the adaptability necessary to adjust to your company’s business dynamics.

Pharma companies that need to scale rapidly should look for CMOs that have a robust contract manufacturing software solution that facilitates adaptability and offers the agility required to respond to market fluctuations and industry demands. With the right capabilities, a CMO should be able to scale as needed and assist you with low-volume manufacturing, high-volume manufacturing, or anything in between.

However you’re needing to scale, you’ll want a CMO with an efficient process in place for effective change management. Some pharma contract manufacturing organizations have a master template for each product variation – an approach that isn’t sustainable. A single mistake can ruin an entire batch, which wastes time and materials and adds unnecessary expenses. A modern contract manufacturing software solution that allows product variations to be managed through a single master template optimizes change management by saving time and reducing errors.

The Bottom Line

Every pharmaceutical company has unique requirements that specialized pharma contract manufacturing companies can help them fulfill cost effectively. To avoid partnering with the wrong one, first identify the proven CMOs that have implemented modern contract manufacturing software to provide the transparency, adaptability, and scalability modern pharma companies require.

References:

1. "Remarks by Acting Commissioner Janet Woodcock to the FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World,” FDA website, October 26, 2021.
2. "Dare to be Different: It’s time to revamp collaboration in life sciences manufacturing,” by Anne Marie O’Halloran, Barry Heavy, and Greg Ciccarelli, Accenture, 2019.