What to Consider When Developing an API Manufacturing Process

 

In pursuit of growth, businesses push to develop more efficient business processes. All business sectors follow this trend, and the pharmaceutical sector is not left out. Leaders in this sector are not unsurprisingly looking for effective outsourcing strategies to improve the level of developing and manufacturing custom active pharmaceutical ingredients, the most important component of medicine and therapeutic products.

One of the ways to improve drug manufacture and development levels is to develop a better custom API manufacturing process. In this article, you will learn more about developing a custom API manufacturing process and how it can be improved upon.

Factors to Consider Before Undertaking an API Manufacturing Process

When developing custom active pharmaceutical ingredients, there are several vital factors to consider from different standpoints. The first question to be answered is, can the reactions (mixing) be done at the site of manufacture regarding handling the needed reagents and solvents? The second question is that does the manufacturing plant have the capacity to accommodate the process’ temperature range?

You should also look at the evaluation of the particular hazards and implications of safety of going through with the process as a less important factor.

Proximity of raw materials

Checking for the availability of vital raw materials is key and should be appraised. The idea is to make sure that all needed raw materials are available from existing suppliers. If not, new suppliers should be sourced. It is important to avoid the scenario of being unable to access a particular (or more than one) material because proper raw material assessment was not done. It gets worse when the problem is being unaware of the challenges that come with importing some of these raw materials.

Manner of waste disposal

It is also important to examine the process from the environmental perspective; how it will affect the environment after the utilization of the raw materials. The waste from the reaction must be properly handled and disposed of. The process should also be scalable from the place of reaction (laboratory) all the way to the commercially projected scale.

All hazards, waste, and by-products should be properly examined also, as it is common knowledge that scaling could make the impact of a specific waste product, by-product, or hazard much more difficult to contain at large scale levels. This is why all assessments and appraisals should be well done from the beginning.

Other factors

There are many other factors that affect this process before, during and after. Factors such as cycle time, control of the particle size of the product, clinical phase, polymorphism, and issues such as step filterability all affect the process one way or the other. All these factors have the potential to affect the quality and cost of the final product.

Hence, it is important to note all of them when looking to develop and introduce a quality product into the market while also looking to manage the pricing demands of the customer.

Finally, throughput is another key factor to watch out for when developing an API process. This lowers the cost of the custom API and reduces the amount of waste from the process. As a result, numerous benefits come to the company, the patient, and the environment.

Conclusion

For more than a century, AbbVie has developed quality custom API processes and served numerous big-pharma firms right from the heart of Chicago, Illinois. As a CMO, we offer fully integrated CMO services that help you deliver quality to your customers and patients.