Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.
It is difficult to be the pioneer seeking a partner who wants the opportunity to be on the cutting edge of new technology — and to participate in the future of medicinal chemistry.
Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.
The past decades have seen a maturation of the contract manufacturing and development organization (CDMO) business and an increased level of collaboration between pharmaceutical companies and CDMOs. This article explores a number of drivers behind this trend.
You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.
Being exposed to different CMOs during a well-structured bidding process will allow small and virtual pharma companies to assess what type of CMO would be the best fit for their business model.
Your manufacturing CMO has just announced that it is preparing to implement a new technology that will improve quality and save time and money. Now, you just need to figure out if you are able to align the needs of your product or products and get on board with the change. Innovation and improvement efforts need to consider all aspects of the impact, including quality and regulatory considerations, supply constraints, market constraints, and cost.
While presenting a webinar on the CMO selection process not long ago, I had a moment of clarity. Even though I didn’t include the following words in 36-point block letters on any slide, I suddenly discovered the essence of the lecture
You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.