Straight to the source of contract manufacturing

What benefits does an embedded CDMO model bring and how Pfizer CentreOne operates within one of the world’s premier biopharmaceutical companies. 

Pharma companies often need to access specialised manufacturing resources, facilities and capabilities to progress a drug from development through to commercial production. The outsourcing landscape is very fragmented and highly competitive, with a wide range of full service and niche contract development and manufacturing organisations (CDMOs) to choose from, as well as pure play and embedded CDMOs.

The embedded CDMO model

The embedded CDMO is a unique option within the pharma and biopharma outsourcing space. Although it is not new, there is still a lack of understanding about it in the market.

An embedded CDMO operates as a self-contained organisation within a larger biopharmaceutical company. Through this embedded model, the CDMO can offer access to technologies, capabilities, and expertise of the parent company while simultaneously protecting the IP of the prospective customer.

One advantage of the embedded model is that it can often implement scale up in a reliable way, as embedded CDMOs have been through the process many times through their parent company’s own development work. By having access to experts who can anticipate issues that may occur during scale up before the process begins, embedded CDMOs can offer their partners reassurance.

Many CDMOs strive to offer a full suite of services from development through to commercial manufacture to simplify the supply chain for prospective customers. In order to provide that service, CDMOs must have experts that understand what it takes to go from lab or small scale to larger, commercial production scale. The CDMO must have expert knowledge of the container system, the drug substance, the excipients, the equipment and the conditions needed for tech transfers and scale-up to run smoothly. 

With embedded CDMOs, it is often much clearer in which areas they have a stronger offering having built up specialist expertise through their parent company and invested in the appropriate technology over time. Other CDMOs may base new technology investments to keep up with market trends without having built the right expertise, potentially adding greater risk to customer projects.

With extensive experience through their own development work, access to global manufacturing expertise, world leading technologies and contemporary facilities, embedded CDMOs are ideally placed to implement effective tech transfers and scale-up.

Regulatory demands and compliance

Businesses operating in a heavily regulated industry, such as pharmaceuticals, are very likely to know about the regulations that may apply to the geographical location they will market their medicine in, and they need to ensure that their CDMOs are just as knowledgeable.

By understanding the regulations that apply to each step of the development and manufacturing process, embedded CDMOs can often anticipate questions that might arise and help avoid costly delays.

Good practice (GxP) requirements are ever changing, and they can vary from location to location. Pharma companies and their CDMOs need to remain up-to-date with any challenges and changes they may face and invest accordingly. Embedded CDMOs will often invest the money needed to do this, as they will need to ensure that their own products also meet the necessary requirements. 

Protecting intellectual property

Understandably, pharma companies are fiercely protective of their intellectual property (IP) and other forms of sensitive data. There is a current misconception in the industry that embedded CMDOs cannot protect important IP from the larger companies in which they work.

Embedded CDMOs will not risk the legal repercussions and the damage that failing to protect a customer’s IP would do to their reputation and their business. Because the embedded CDMO will usually implement the strict policies and procedures of the parent company it operates within, in order to protect IP and other forms of sensitive data. This means that partners can rest assured, knowing that important information such as trademarks, copyrights, patents, process and other pieces of proprietary information will be kept entirely confidential from development through to commercialisation.

In conclusion

There is clearly a lot to think about when it comes to choosing the right CDMO. While standalone CDMOs can work well for many pharma companies, the embedded model is becoming a strong option. By having constant access to the expertise and capabilities of big pharma, embedded CDMOs can advise on changing regulations, scale up effectively, protect partner IP, provide access to ‘in demand’ technologies and work in collaboration to deliver personalised service. Going forward, it is likely that the embedded CDMO model will continue to grow.