A pharmaceutical contract manufacturing organization (CMO) is a third-party company that specializes in providing manufacturing services for pharmaceutical and biotechnology companies. They offer a range of services, from drug development and clinical trials to commercial-scale production. A pharmaceutical CMO utilizes cutting-edge sterile filling equipment and a strict quality control system implemented by highly skilled professionals. Outsourcing manufacturing to a CMO can also reduce labor costs and speed up the production process without sacrificing product integrity.
Let’s explore the advantages of using a CMO and why your business should consider outsourcing your next project.
1. Higher Quality Products
CMOs are highly specialized in their field, with access to state-of-the-art sterile filling equipment. In place is a stringent quality control system to ensure that your products meet industry standards, implemented by a team of highly skilled professionals. This team is trained to identify and rectify any issues that may arise during the manufacturing process, leading to better quality products and a reduction in wasted material.
2. Expertise
Due to the precise nature of aseptic filling, CMOs must be up-to-date on the latest technology and equipment required for the development and production of pharmaceuticals, as well as industry standards around aseptic techniques and behaviors. Through sophisticated manufacturing processes, self-contained equipment, and technology, they guarantee that your products will be well-produced and in compliance with strict regulatory requirements.
3. Increase Scalability
Utilizing a contract manufacturing organization provides an advantageous solution to scalable manufacturing processes. CMOs have the capability to adapt their manufacturing processes to fluctuating demand, meaning your business can scale up or scale down production as needed and avoid excess inventory or shortages. Optimizing your manufacturing process through scalable manufacturing reduces your financial risk while keeping your productivity high.
4. Improve Supply Chain Management
Pharmaceutical CMOs can provide your business with cost-effective solutions for manufacturing and supply chain management due to their vast knowledge of the industry and established relationships with suppliers. By identifying cost savings opportunities and implementing strategies to reduce waste and increase efficiency in production, these organizations allow you to enhance your supply chain fully.
5. Established Infrastructure
Regulatory compliance can be a time-consuming and costly process for your business as a drug sponsor. However, CMOs have already obtained regulatory approvals, and their quality systems are already set up to comply with cGMPs (current Good Manufacturing Practices), which ensure the products will meet regulatory requirements. Partnering with a pharmaceutical CMO allows you to leverage their existing infrastructure, equipment, and quality systems and reduce the overall time and cost of drug development.
6. Reduced Labor
Aseptic operators can take up to a year to be fully trained and confident in a sterile environment. This type of labor force is extremely costly. Using a CMO can reduce labor costs by providing the expertise of highly trained professionals minus the cost of recruiting, training, and retaining skilled staff for in-house aseptic manufacturing. At Afton Scientific, we take the time to invest in our personnel to guarantee that we can continue to provide services that are on par with the latest manufacturing techniques, regulations, and quality standards.
7. Better Allocate Your Talent
By freeing up in-house staff from manufacturing responsibilities, you can concentrate on other critical activities that are essential to the success of your business. Outsourcing manufacturing to a pharmaceutical CMO can ensure that your focus can be shifted to whatever your expertise is — drug discovery, running clinical trials, marketing, distribution, etc. — ultimately speeding up the development of new drugs and bringing them to the market more quickly.
8. Dedicated Project Management
Through a contract manufacturing organization, you’ll have a dedicated project management team that oversees the sterile filling manufacturing process, working closely with you to understand your requirements and goals. A project plan will be created which outlines the scope of the work, including timelines, milestones, and budget restrictions. This team also provides you with regular updates to keep you informed of the progress, and they will identify any potential issues or delays and develop solutions for you.
9. End-to-End Options
Working with a pharmaceutical CMO that can offer end-to-end options, rather than outsourcing to multiple vendors for each step, greatly streamlines the process. End-to-end options grant you access to a comprehensive production process, from early-stage development to the commercial-scale manufacturing journey. Most CMOs will also offer their services “a la carte”; these may include: drug development, pre-clinical/clinical manufacturing, commercial manufacturing, analytical testing, stability studies, finishing operations (label/pack/serialization), regulatory support, and distribution.
10. Partnership
There is a high level of trust that must be built between you and your CMO. When you find the right CMO, the relationship is less supplier/client and more of a partnership. A good partner understands that your success is their success and works with you to make it happen. As additional products come into your pipeline you’ve already laid the groundwork with a partner you know and trust.
In review, outsourcing manufacturing to a pharmaceutical CMO can offer several advantages for your business that can greatly improve the outcome of your production. Partnering with an experienced CMO like Afton Scientific can help you get the best support available from start to finish. Visit our website to learn more about our sterile filling services and how we can help propel your product to success.