One of the biggest decisions to be made in a customer’s outsourcing of their ADC program is where to place the analytics for the project. Often overlooked, or a decision made at the last minute, it can make or break your project. The right selection can be the difference between hitting and missing your project timelines.
There are a plethora of companies claiming to be able to develop and test ADC products; many of these are CROs or small contract manufacturers only capable of development activities. But where should you place the testing? And what happens if things don’t go to plan? Here are a few reasons why your analytical development and testing is better left with your CDMO.
- To achieve good process development outcomes, you need good analytical method support from Day 1. This can be achieved when process and analytical development staff work together as part of a project team. At Piramal, PD and AD staff share office space and are integrated from as early as the proposal stage.
- You need staff with a wide range of backgrounds from small molecule to biological assay expertise. Your analytical development team should have this to be able to span the range of testing required to support your product.
- Do the staff that are performing the analytical development have a working knowledge of the product, conjugation process, and what factors influence its quality attributes? Can this be answered by most CROs?
- Having the staff that developed the methods on site that can support quality control is a big plus. Information can be lost in translation when methods are transferred. Development staff can also support any laboratory investigations as SMEs.
- Are the staff developing your methods thinking correctly about their end use? It's important to think about the correct materials needed to prove the method is fit for purpose. Is the method suitable for a QC lab? Have all relevant ICH Q2 parameters been considered? These questions and many more are what Piramal analytical staff will consider for you.
- Streamlining your development programme with the release of clinical/commercial batches is possible through a single contract, single PM, and an integrated analytical development and quality control capability all under one QP. Separate analytical testing units slow down the release process and increases the risk of miscommunication. Delays at separate test houses can stop all product release and increase pressure between clients and different parts of their supply chain.
- Delays in any analytical development phase of your project can be better managed with flexibility that can help avoid any late or cancellation fees for your GMP manufacture.
So make the right choice. If you are looking for the best chances of successfully meeting your project deadlines, choose your partner for analytical development carefully. A partner that combines a process and analytical development strength with GMP manufacturing and release capabilities, and who always has the end in mind, is the right partner.
- Allan Davidson, Analytical Development Manager, Piramal ADC Services, Piramal Pharma Solutions