The right development practice and analytics
Regulatory authorities have established stringent standards for risk management based on ISO standards, including cGMP. Companies need to flag Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) so that the CDMO is aware of them.
It is also important to think about scaling-up for later trial stages and market launch. An effective manufacturing partner will root out any issues during that process and offer concrete approaches, especially if a company has been using external lab services for tests or components. The company itself must determine how data is shared and have robust standard operating procedures for the transfer of analytical methods.
Starting cGMP clinical manufacturing
Once the clinical manufacturing process begins, any interruption can become extremely costly. Engineering runs with placebos should be made to determine fill volume specification and to see if there are any problems.
The time needed for visual inspection and labeling should also be measured prior to starting. A sponsor should request from a manufacturing partner the time required to complete release testing to determine how long it will take to get a formal batch release. What storage requirements are you going to need after filling or between steps? Will enough -20 to -80 chest freezer capacity be available on-site for your project?
If lyophilization is being considered, start primary freeze-dried stability studies early. Frozen formulations are often used to extend the time of unstable biologics such as large proteins.
Another aspect to consider is automation, with some exceptions. For example, early phase toxicity studies or filling small batches can be done by hand. For larger volumes, however, automation offers many advantages, notably speed and safety. When using filling machines, it is important to know what systems are in place including capacity in terms of speed and formats.
Choosing the right partner
Because manufacturing a drug and submitting it for approval is complex and expensive, many companies choose to outsource the process. Be realistic in your timeline. Ensure that the candidate partner can do the work within the schedule and budgetary limits and handle the compound safely.
Quality assurance is a key criterion. The quality audit system needs to match the contracting company’s quality assurance expectations such as the ability to perform the necessary analytical tests. Your partner should also have the drug sponsor’s packaging configuration and be able to source it in time. As you can see, there are many intangible aspects to make for a successful project, and that is why the use of the checklist is so important.
1 Nature. 2020 FDA Drug Approvals. 5 January 2021. Accessed 22 June 2021. Available at: https://www.nature.com/articles/d41573-021-00002-0