The focus during early development is on establishing a robust formulation and progressing the development programme. This involves balancing a range of technical and commercial priorities, including product performance, stability, manufacturability, patient needs and development timelines.
While commercial manufacture may still be some way off, decisions made during this stage can influence future manufacturing options, including technology transfer, commercial manufacture and long-term supply chain resilience.
Mark Vlasic, Business Development Manager
Formulation is only one part of a successful product
Developing a successful formulation requires careful consideration of factors such as bioavailability, stability, manufacturability and patient acceptance.
Alongside formulation development, it is also important to understand who owns the formulation intellectual property, whether proprietary technologies are being used by the CDMO, and what these choices could mean if manufacturing ever needs to be transferred.
As Mark Vlasic, Business Development Manager at Douglas CDMO, states, “Getting the formulation right is always the priority. But it’s also worth understanding how the technologies and processes you choose today could affect your options later.”
Manufacturing flexibility should be considered early
As products progress through development towards commercial manufacture, priorities often evolve. Companies may need to increase manufacturing capacity, establish a secondary manufacturing site, or transfer production to another CDMO.
While technology transfer is a routine part of the pharmaceutical industry, it is rarely as simple as transferring documentation and process instructions.
Formulation design, analytical methods, manufacturing processes and proprietary technologies can all influence how readily a product can be transferred to another manufacturing site.
Where these factors create additional complexity, technology transfer may require further formulation development, analytical method redevelopment, stability studies, process validation and regulatory assessment before commercial manufacture can resume.
Softgel development provides a practical example
For innovative pharmaceutical products, the formulation containing the active pharmaceutical ingredient (API) is typically owned by the sponsor. However, the softgel shell formulation and associated manufacturing process may incorporate proprietary technology developed by the CDMO.
If manufacture is transferred in the future, another manufacturer may not have access to that proprietary shell technology. Depending on the product, redevelopment may be required before commercial manufacture can continue.
This does not mean proprietary technologies should necessarily be avoided. In many cases, they provide important technical advantages and represent the most appropriate solution for a particular product. The important consideration is understanding how these technologies may influence future manufacturing options before development begins.
Questions worth asking before development begins
Before selecting a CDMO, it’s worth discussing how today’s development decisions could influence future manufacturing.
As Mark explains, “When you’re focused on solving the technical challenges in front of you, it’s not always obvious how today’s decisions could affect future manufacturing. Having those conversations early helps keep your options open later down the track.”
Questions worth discussing with a CDMO include:
- Will proprietary formulation or manufacturing technologies be used?
- Who owns the associated intellectual property?
- How easily could manufacture be transferred in the future if required?
- What additional development activities might be needed to support technology transfer?
- How do today’s development decisions support long-term commercial manufacture?
Considering the full product lifecycle
There is rarely a single “right” formulation strategy for every product. The best approach depends on balancing immediate development priorities with longer-term manufacturing considerations.
“The earlier you have these conversations, the more options you’re likely to have later.”
Mark Vlasic, Business Development Manager
At Douglas CDMO, we partner with clients to navigate these decisions, bringing together formulation expertise and manufacturing experience to support products from early development through to commercialisation.
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