Challenges of Biologics Process Development

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In this article, we will discuss the challenges of biologics process development. But before we look into that, we will discuss what the above term is for those folks who don’t have the foggiest idea of what it means. 

What Biologics are

A biologic or biopharmaceutical product is a pharmaceutical medicine or product that is manufactured in, semi-synthesized, or extracted from biological bases. These pharmaceutical products include blood components, vaccines, somatic cells, allergenic, tissues, gene therapy, and therapeutic proteins. Click here to learn more about therapeutic proteins.

Biologics are compound substances with large molecules that can only be manufactured with the aid of controlled processes and sophisticated technology. To develop and commercialize a biologic, you will need to understand the regulatory, logistical, and scientific challenges that are peculiar to biologics. 

As a result of the above, we will look at some of these challenges to arm you with the required understanding to operate in this field. 

Safety Challenges

When biological material is sourced wrongly, it could lead to contamination as well as safety issues that could hamper the production of the drug and even affect public health. 

When the case is serious, this mistake could destroy the development cycle of the product. Such mistakes could cost up to tens of millions in dollars to cater for investigation, corrective actions, cleanup, manufacturing downtime, and lost sales. 

To prevent this issue, the development teams that partner with CDMOS (contract drug manufacturing organizations) that develop biologics must ensure that the vetting is both proactive and strict. The supply chain must be thoroughly validated to ensure total compliance. 

Suppliers must always provide viral inactivation proof to guarantee the safety of the biological material being supplied. This will reduce the risk of destroying all the work put into the development of the medicine. 

Furthermore, the manufacturing organization must ensure that they are not only familiar with the cGMP guidelines, but that they also follow those guidelines and protocols in all the relevant areas. 

Formulation & Manufacturing Challenges 

This set of challenges is the next daunting when it comes to the process development of biologics. To overcome these problems, the organization must have at hand adequate project management skills with appropriate strategy and approach. 

Since these products are gotten from biological sources, their large molecules hamper their durability when compared to products that have small molecules. Hence, it is challenging to formulate them into tablets or capsules. This is the major reason they are developed to be used as injections. 

Also, due to their unstable molecular nature, terminal sterilization cannot be used at the rounding off of the development process. As a result of this, aseptic processing has to be used instead. This, in turn, further complicates the entire operation. Visit to learn about the basics of aseptic processing.

Furthermore, for most of these products, protein aggregation is a constant worry as they are quite vulnerable to it. This is more so if the drug is a vial or an already-filled syringe. 

Apart from the molecular structure of the materials that can cause a lot of difficulties as far as the formulation of biologics is concerned, the role of environmental conditions cannot be overemphasized. 

Due to the sensitive nature of these materials to light and temperature, they can easily degrade or shear during filtration. 

Also, since they are lyophilized, the biologics must be frozen to ensure that they are physically stable. Hence, the cycle of freezing and thawing must be managed properly, or else the product can get damaged. 

Furthermore, environmental conditions must be controlled at all times to prevent setbacks. This is very necessary during the early stage of the process development. 

Due to the difficulty in defining a biologic, the process of manufacturing these products is placed under strict guidelines and regulations by regulatory bodies to ensure steady reproduction of the medicine to meet the required specifications. 

Therefore, to overcome the challenges involved in the formulation and manufacturing of these drugs, the manufacturers are expected to have experiential knowledge and understanding of filtration, biologic mixing, as well as other relevant process factors. 

Analytical Challenges

As we have said, biologics have large molecules that are complex with different chemical entities and attributes. Hence, their characterization can be somewhat difficult which means the analysis of these materials cannot be carried out using traditional assays and imaging. 

Therefore, manufacturing organizations focus on analyzing and identifying the principal components as a way of analyzing these substances. Apart from focusing on the components, they also look at the methods that will ensure consistency during every batch production. 

Activity and purity are considered during the analysis. Hence, purity is not the only thing that should be assessed; any activity involving biological loss at several points of the biologics process development must also be assessed. 


In the article above, we have discussed the challenges of biologics process development. We also provided recommendations that manufacturing organizations should consider that will enable them to overcome these challenges. 

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