Manufacturability Assessment | Biologics

15+ Years’ Experience

We have over 15 years’ experience of assessing, optimizing and expressing biotherapeutic drug candidates .

1000+ Biotherapeutic Candidates

We have assessed more than 1000 Biotherapeutic candidates.

1500+ Product Variants

We have expressed over 1500+ Biotherapeutic candidates product variants.

Make informed decisions

Many biological therapeutics being developed today are at risk from potential Post-Translational Modifications (PTMs) and chemical and physical stability issues. These structural modifications are considered relevant to determining a candidate’s overall long-term stability.

To proactively minimize potential clinical failure, we offer a set of proprietary in silico tools for a comprehensive Manufacturability Assessment of your target candidates. This assessment is applicable for all protein types whether derived from mammalian or microbial expression systems.

Our Manufacturability Assessment includes the analysis of post translational modifications/chemical stability and physical stability.

PTMs can affect binding affinity, function and safety of your potential drug

PTMs can affect binding affinity, function and safety of your potential drug. They can often impact your molecule's bioactivity and stability and can result in the production of different isoforms of your desired product.

While not all PTMs will result in high risk issues, many have the potential to affect the manufacturability of your biologic. Our Assessment Services will identify potential PTMs and chemical issues and highlight those that are of the highest risk. Our assessment can evaluate:

Deamidation sites
Aspartate isomerization sites
Oxidation sites (Methionine and Tryptophan)
Free-Cysteine Thiol groups
N & O-Glycosylation sites
Lysine Glycation

Monitoring physical stability and aggregation of biotherapeutics can be a major challenge for drug developers.

This is due in part to the fact that aggregation can occur at very different stages in the biomanufacturing and development processes and can also manifest itself in very different ways. Low host viability, low productivity, the presence of inclusion bodies and the development of opalescent solutions or precipitates are clear indications of stability issues.

With these challenges in mind, we have developed a proprietary suite of predictive models designed to assess the aggregation potential of your monoclonal antibody. Our in silico aggregation assessment tool uses sequence and structural algorithms to identify motifs with a potential for aggregation.

Below is a comparison between the in silico aggregation prediction of 6 monoclonal antibodies (wild type and variants) as compared to the experimentally determined levels. Lonza’s tool correctly predicted 6 out of 6 mAbs on the propensity to aggregate.