How to select a CDMO for a softgel development project
In the dynamic world of soft gel capsule development, outsourcing to a Contract Development and Manufacturing Organization (CDMO) can be a game-changer. But what exactly should you know before doing so?
This guide breaks down the essential steps to choose the perfect softgel CDMO for your development project.
What is a CDMO?
Let’s start with the basics: A CDMO in pharma stands for Contract Development and Manufacturing Organization. It typically performs development services and manufactures a variety of products on behalf of their customers. CDMOs are specialized in manufacturing, whereas typically the regulatory, marketing, and medical aspects are managed by the client (who is also the owner of the product).
While some pharmaceutical clients who outsource their product development and manufacture to CDMOs look for the full range of services from formulation development to commercial manufacture, others are interested only in some of them, e.g. analytical development.
What is the difference between a CMO and CDMO?
In the pharmaceutical industry, the key difference between a Contract Manufacturing Organization (CMO) and a Contract Development and Manufacturing Organization (CDMO) lies in the range of services they offer.
While a CMO primarily focuses on manufacturing and producing registered drugs according to already established formulations and processes, a CDMO provides development services in addition. They can encompass formulation and process development, analytical development, stability testing, and preparation of registration documentation.
Why are softgel capsule CDMOs so important?
The development and manufacture of softgel capsules require highly specialized know-how—and that know-how is often accumulated in decades of experience.
As softgel capsules are commonly niche products and are not as widely produced as e.g. tablets, it is not economical for pharmaceutical companies to establish manufacturing capacities and know-how for what is often only one product of their entire portfolio. They frequently decide to outsource the development and manufacture of their softgel capsules. According to some estimates, more than 80% of the marketed softgel capsules are produced by specialized softgel CDMOs or CMOs.
Who are the biggest softgel capsule CDMOs?
The following long-established companies are known for their softgel development and manufacturing capabilities:
· Catalent
· Procaps
· Aenova
While the largest softgel CDMOs bring advantages such as supply chain security and potentially more know-how, big doesn’t always mean best for all projects. Along these largest players, many mid-size and small softgel C(D)MOs may bring advantages to specific projects.
How is a softgel capsule CDMO selected?
The selection process for new development often includes defining a target product profile, longlisting and request for information if needed (RfI), shortlisting and request for proposals (RfQ), and meeting potential CDMOs. Let’s dive into the crucial stages:
1. Target Drug Product Profile (TDPP)
The first step is defining the target product or development profile. This involves understanding the specific requirements of the softgel capsule, including its preliminary specification, target territories, SKUs, clinical and regulatory requirements, as well as commercial volumes.
This stage is crucial as it sets the foundation for the entire project and helps align the CDMO's capabilities with the project's needs.
2. Optional: Long List and Request for Information (RFI)
The next step is a pre-selection of potentially suitable CDMOs. If no sufficient data is available on suitable CDMOs, a RfI process can be initiated before a proposal is requested. Key aspects to focus on include:
A CDMO’s experience and track record in developing similar softgel capsule formulations.
The technical expertise of their team and the facilities available for development.
Their approach to development, including handling of similar liquid formulations, analytical and regulatory expertise, and authority inspection status.
This stage helps in pre-screening potential partners and understanding their capabilities and approach. It also sets the stage for a more detailed Request for Proposals (RfP) process.
3. Shortlisting and Request for Proposal (RfP)
From the responses received or based on the long list, the next step is to shortlist 3-4 suitable CDMO candidates and to submit a request for proposal. A RfP typically includes the TDPP, information on the drug substance, services requested, target timelines, and commercial volume. Based on this information, the CDMO assesses the fit with their capabilities and resources and may prepare a business case for the product.
Ideally, a comprehensive technical proposal including scope, timelines, and budget should be provided by the CDMO as the basis for further discussion.
4. Meeting and decision
After evaluation of the CDMOs proposals, the list of CDMOs is commonly narrowed down further. At this stage, it is advised to meet the team of the CDMO on site and discuss the project in more detail. The main focus should be placed on the following:
Detailed discussion on their proposal.
The team´s experience and confidence, as well as their approach to project management.
Understanding their documentation quality, regulatory expertise, and internal review processes.
Want to read more? For more information on CDMOS, go to the full version in our Expert Resources section.
How do we support customers during the CDMO selection process for soft gel capsules?
How our team can help:
+ We prepare a preliminary assessment of sourcing strategy, support the preparation of target product profiles and RfP documents
+ Extensive database of potential experienced partners for the development and analytical services of soft gelatin capsules
+ Independent technical expert assessment of development proposals and shortlist with recommended CDMOs