Challenges Faced in Potent Drug Contract Manufacturing

 

The potency and number of high-potency drug substances are increasing. Formulations that work with highly potent APIs are confronted with ascertaining the safety of people during manufacturing and development and patients and healthcare workers when using the final products. This means facing potential challenges with the uniformity of the formulation, proper handling, and drug content analysis.

 

Problems Faced by high Potent Drug Manufacturing Companies

1. Poorly Soluble HPAPIs

The major challenge facing the manufacturing industry is conveying OSD (oral solid dosage) formulations that contain highly poorly water-soluble HPAPIs – highly potent active pharmaceutical ingredients. Curing cancer is still a key area of focus for worldwide pharmaceuticals, and it continues to drive an incredible amount of development.

Most oncology products use highly potent active pharmaceutical ingredients and innovators. In addition, their CMDO partners have seen a tremendous increase in the number of global development projects involving highly potent active pharmaceutical ingredients.

Advanced manufacturing methods and formulations for highly potent active pharmaceutical ingredient compounds will become more integrated and understood earlier in development, with inventions in engineering and capsule materials being particularly significant.

Manufacturers are fixing the problems of highly potent active pharmaceutical ingredients drug production and delivery by implementing new drug substance and formulation processing methods, including amorphous solid dispersions and lipid-based formulations.

The need to provide highly potent active pharmaceutical ingredients and other complex compounds now under development is adding to a migration towards condensing formulations in hydroxypropyl methylcellulose. Suppose an active pharmaceutical ingredient is sensitive to water or formulated as ASD. In that case, hydroxypropyl methylcellulose capsules can help to control the effects of water relative to active pharmaceutical ingredients and formulation stability.

 
2. Shortage in Skilled Labour

A major factor that will continue to affect biopharma manufacturing in the future is the limited availability of skilled labour. While some of the problems surrounding the shortage of labour could be fixed with the use of automation, the major challenge will persist.

Preparing workers for science, technology, engineering, and mathematics – STEM – industries will need further funding in the education sector as well as territory – state, city, or nation ready to fix this challenge will be poised to dominate the industry.

 
3. Flexibility in Production

The rise of drug development for rare diseases and orphan diseases is affecting the sector, improving the importance of flexibility in production. As drug development becomes more detailed in the target indication, so also is the patient population.

Markets for drugs that target specific subsets or for rare diseases drugs that treat certain subsections of a patient population decrease the market size for products. This reduces the size of produced batch requirements. These smaller batch production requirements have led many manufacturers to use small-tier and mid-size CMOs who have the scale of equipment designed to meet the demands of a small patient population.

Contact AbbVie contract manufacturing for your potent drug contract manufacturing.