The development process for a biologic is generally divided into cell line development, upstream and downstream development, manufacturing, and formulation development, where each development process holds its own purpose along a biologic’s journey to commercialization.
In this article we are going to answer some questions related with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development, and what to expect from the development and manufacturing partner during the drug product process development phase.
So, let´s start!
During drug product process development for a biologic, what are the biggest challenges?
Drug product process development can be very costly but if you plan it well, then the benefit outweighs the cost.
It is essential to invest adequate resources in the development stage, where pharma and biopharma companies and their partners have to do enough development before the drug product process development phase.
However, not every company is able to put unlimited money and other resources towards such research. For example, a small biotech company may not have the same resources available compared to a large pharma company for extensive development work.
That is why many small/virtual biotechs even up to mid- to large pharma, opt to partner with an experienced contract development and manufacturing organization that can build and execute necessary protocols.
Clearly, an efficient, customized, thoughtful drug product process development program must be built and followed to help take the biologic molecule to the next level.
Innovator biologics vs biosimilars, is there a difference in process development?
The truth is that they each have their own set of challenges.
For example, for innovative biologic, the challenges are timeline and the costs associated with the basic research, because it requires extensive research to understand the therapeutic effect, side effects, duration of action, elimination, and many more properties. The innovative biologic must demonstrate proof of efficacy for an intended indication and safety in randomized, controlled, clinical trials.
On the other hand, the biosimilars are less challenging than biologics because the competitor of that biosimilar drug is already out in the market and the research has already been done. The main challenge for biosimilars is that they must be carefully engineered to match the reference products. However, a biosimilar does have the opportunity to differentiate itself against an established competitor by leveraging new or different delivery methods. From a process development perspective, the challenge resides within physical and chemical characteristics of a product. The understanding of these characteristics is very important as that will help determine which filling mechanism and filtration process will be more efficient during drug product manufacturing.
What should pharma and biopharma companies expect from their development and manufacturing partner when they’re ready for drug product process development?
The success of a project increase when the pharma and biopharma company secures knowledge of the physical properties of the molecule, route of administration and targeted patient population, which are covered during the technology transfer phase.
When drug scale-up is initiated for clinical studies, the CDMO partner should look to understand the formulation, the excipients, and stability at the current scale of the biologic drug.
Another important issue is that the CDMO partner has to have the proven expertise with industry rules and regulations to help move drugs through the “Stage Gate” process.
What mistakes do pharma and biopharma companies tend to make during drug product process development? How do we mitigate those?
One of the mistakes is not having enough data or not performing sufficient stability studies. This can really hurt a company’s product going into the next phase.
To mitigate this, it’s important to understand the formulation and how the product reacts to different conditions or different environments, which is accomplished through a robust study design.
At 53 Biologics, as soon as a company brings us their product, we explore those details with them in order to make good decisions for manufacturing early in the process.
As a development and manufacturing partner, we have technical transfer templates that we customize with the pharma and biopharma company to capture the type and extent of data collected to date by them. This will ensure that we minimize challenges during our formulation, filling, or inspection processes, and it helps us to conduct a smooth and successful tech transfer or scale-up.
53Biologics is leader in biologics development and manufacturing and our mission is to support you from pre-clinical up to commercialization.
Are you looking for a CDMO partner for your biological product? Meet out team to discuss your project!