In the biopharma industry, it has become commonplace for companies to outsource both manufacturing processes and research efforts. By relying on contract manufacturing organizations to make their products and conduct research, they eliminate the costs associated with purchasing and maintaining a manufacturing plant and/or research lab. In fact, the reliance on CMO outsourcing is expected to grow in terms of capacity and revenue in the coming years.
CMOs and contract research organization (CROs) can improve their own operations and decrease their capital investment and equipment maintenance expenses by moving to the cloud. They will also gain other important advantages by switching to a cloud infrastructure. Then, these benefits can be passed on to their clients, making an even stronger partnership.
The Growing Partnership Between Biopharma Companies and CMOs
The relationship between biotech and pharmaceutical developers and CMOs has been mutually beneficial. Contract manufacturing organizations now offer different levels of assistance to companies ranging from R&D to streamlining processes, boosting efficiency, and decreasing overhead costs. Today, biopharma companies can find a range of CMO services available. These include pre-formulation, formulation, pre-clinical and clinical research, method development, and commercialization.
Drug sponsors and biotech developers can partner with CMOs at any given point in the research or manufacturing phase. The advantages provided by a reputable CMO are huge. To name a few, they offer:
- Years of industry experience,
- Cost-effective options,
- Support through the FDA-approval process,
- Faster time to market,
- Greater capacity to manage risk,
- Higher capacity to absorb losses if product development fails.
Challenges for Biopharma Companies Working with CMOs
So, this has been a great partnership. Yet, there’s room for improvement. In the past, for a biopharma company, relying on a CMO has meant losing some control. When manufacturing is outsourced, for example, often the developer isn’t able to choose what applications are used to track data. The client has the advantage of using the CMOs on-premises IT infrastructure, but accepts the disadvantages associated with delegating production to a third party.
If the CMO still uses a paper-based system and must digitize their production records, this can also increase lag time and the risk of human error. When it comes to consumer safety, data entry errors, delayed reporting time about compromised batches, and asynchronization in process changes are big concerns.
How Leveraging the Cloud Can Help
The cloud can help bridge these gaps. Advanced cloud infrastructures give life sciences companies, all along the R&D and manufacturing process, the same advantages that it does for companies outside of the industry. Adopting the cloud means:
- Extreme scalability,
- More consistent performance,
- Increased ROI,
- Faster, more effective disaster recovery solutions.
These same business benefits that other organizations have enjoyed for the last 15 years are attainable for CMOs too.
Cloud Advantages for CMOs in the Life Sciences Industry
As more CMOs adopt cloud technology, they will be able to offer better services and prices to their clients in the life sciences industry. More specifically, they can deliver more control to clients, reallocate resources, and save money. At the same time, they will be utilizing more powerful infrastructures that are configured specifically for handling this type of data.
1. Giving Clients More Control
By switching to the cloud, contract manufacturing organizations can use the applications for tracking and managing that clients prefer. Because updates are immediate, customers can be sure that process changes are implemented in real-time. Plus, cloud technology speeds up data collection and reporting time. Your clients will quickly know when a batch has been compromised and can take action.
2. Financial Advantages
Your company already has high capital costs related to labs and manufacturing equipment. But cloud infrastructures eliminate the need to purchase IT hardware. In addition to lower costs associated with maintaining, managing, updating and verifying compliance, the cloud shatters the old capital expense model. Instead of subtracting all the depreciation of assets at year-end, your CMO can write off cloud services as operating expenses.
3. Increased Accuracy & Reliability
Microsoft, Amazon and commercial data center companies have invested billions in their environments. Your company probably isn’t able to and doesn’t want to make that kind of investment in IT resources, but it can still take advantage of the advanced, high-powered technology.
Cloud hosting companies make these high-performing resources available to your company for a fraction of the cost required to build something not nearly as powerful or reliable. These beefy infrastructures deliver better performance which means increased accuracy and consistency in production.
Watch this video to see how one pharmaceutical technology company is using the cloud to expedite therapy development, incorporate digital therapeutics at scale, and improve patient outcomes.
4. GxP Validated Environments
Compliance certification verifies quality controls that guide the manufacturing of medical products and ensure consumer safety. In the past, this has been accomplished by having onsite hardware validated to confirm compliance with regulations by the FDA and other bodies.
Now, cloud validation simplifies regulatory compliance for life sciences companies. Cloud applications connect the laboratory, developer, and manufacturer to provide seamless data processes that are secure and demonstrably compliant.
Illustratively, both Azure and AWS also have GxP solutions and targeted environments for validation. They provide the suite of applications that you need to produce a biotech or pharmaceutical product in a controlled and repeatable way. They also include environmental controls, regulatory documentation, running applications, and practical employee training.
Related article: Cybersecurity Needs to be a Priority for Life Sciences Companies.
5. Better Use of Resources
Procuring more memory and storage space when its needed, and configuring, managing and maintaining components can be a substantial investment on the part of a CMO.
Using the cloud enables drug and medical device manufacturers to focus more resources and time on money-making business activities. Getting rid of on-premises IT systems translates directly to more space, time, and staff available to do work that has value to your business interests. Rather than working to manage and maintain the network, these resources are freed up to do more important activities that generate revenue — like supporting the work of business units.
Similarly, for CROs, utilizing cloud resources enables data to be accessed from any device in the lab. This makes clinical testing and data analysis possible from any mobile device or workstation required. Labs no longer need to rent storage space for servers which decreases overhead while freeing up space for other equipment and work activities.
6. More Design Flexibility
In the cloud, you have resources immediately available with just a few clicks. It lets you customize your configuration to fit your unique business requirements and scale the infrastructure on demand. So, as your business grows and needs change, the infrastructure can easily be scaled to respond to the new requirements and always meet your demands.
Why CMOs Should Consider Moving to the Cloud
Here’s the bottom line. The same benefits that companies get from hiring CMOs are amplified with cloud technology. By taking advantage of the speed, flexibility, reliability, scalability and cost savings that come with the cloud, your company could serve more clients and handle more business from current clients.
You know that your clients spend a lot of time shopping for the right CMO. Each manufacturer offers different options, different levels of control, and different pricing structures. But, if they can get the same product reliably made for less, hiring a CMO becomes an easy choice for them.
CMOs have been slow to adopt cloud technology. But that can be turned into a competitive advantage. Attract more biopharma customers by offering them more choice, more control, more efficiency, and better prices.
How Outer Edge Helps CMOs and Developers
We have the experience to manage the IT structure for biopharma companies and/or CMOs. Whether the facilities, hardware, and network are provided by AWS, Azure, or our own private cloud, the Outer Edge team can do the rest allowing you to focus on your business.
We design, configure and manage the network, provide technical support, system administration, virtualization, and security maintenance. Outer Edge’s role includes managing the operating system and virtual layer, as well as implementing the monitoring, backup, and recovery tools.