Are you wondering where the best place to develop your ADC process is? Multiple providers exist; however, some don’t have the experience or expertise you require to get your project to GMP. The wrong provider could leave you with a process non-scalable or not suitable for a phase I manufacture. This could cost you more money to redevelop but also, more importantly, could delay significantly your entire project timeline.
Here are a few reasons why you should be placing your process development with a reputable and experienced CDMO with GMP capabilities:
- Would you develop a process without understanding the effects on product quality? To enable good process development, strong and robust analytical methods are an absolute requirement. Your CDMO needs an analytical development team which is highly experienced in the ADC field and has the right instrumentation to ensure the development of wide-ranging, fit for purpose methods.
- Developing and manufacturing a process at two different sites means a tech transfer to the GMP site will be required costing additional time, money, and risks.
- What is the track record of the team you wish to place your project with? How much experience do they have with ADC conjugation? How many purification processes have they developed? Do they understand the key product quality attributes and drivers of development?
- Does the provider have GMP capabilities? They may not be aware of the current regulatory expectations if not. Additionally, they will be missing out on very valuable learning experience from manufacturing at scale.
- Does the provider understand the challenges faced and the necessary controls and operations needed for a successful GMP scale-up?
- Does the developer understand the potential impact of process changes and how to assess them appropriately?
- How does the provider control their process inputs? Are appropriate shelf-lives established? Do they have appropriately controlled storage areas?
- Has the process productivity been considered? Very dilute processes or low loading during any purification step would result in a significant increase in manufacturing costs and ultimately prevent further scalability.
We have found that non-GMP providers and technology holders often have limited scale-up experience resulting in process gaps and repeated development work. If you need reliable development for your ADC, contact our team to see how we can help today.- Xavier Despinoy, Head of Development Sciences, Piramal ADC Services, Piramal Pharma Solutions