Manufacturability Assessment

A significant number of emerging biologics are vulnerable to Post Translational Modifications (PTMs) and chemical or physical instability. PTMs 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. Aggregation represents another critical risk to biologic stability and manufacturability. It can arise at multiple stages of development and production, often manifesting as inclusion bodies, opalescent solutions, or precipitates that signal compromised stability and productivity.

Evaluating these structural modifications is essential for understanding a candidate’s overall stability profile.

If these issues are not addressed early, they can lead to costly delays, failed trials, or suboptimal therapies. A candidate that looks promising in theory may falter in practice due to poor developability or manufacturing challenges.

Building on the insights from PTM and aggregation assessments, we offer protein engineering strategies to transform liabilities into opportunities. Rather than stopping at detection, our Epibase® and in silico manufacturability platforms enable proactive optimization of your candidate.

These tools allow you to:

• Screen sequences for problematic features
• Identify beneficial substitutions
• Re‑engineer proteins for enhanced activity and stability
• Reduce immunogenicity through targeted design

To proactively minimize potential clinical failure, our biologics manufacturability assessment can analyze all protein types, whether derived from mammalian or microbial expression systems, with just the sequence. 

With our manufacturability assessment, you can; 

• Perform targeted manufacturability assessment with proprietary in silico models screens sequences for PTM hotspots, chemical liabilities, and aggregation motifs.
• Rank risks by predicted impact on stability, activity, and manufacturability.
• Design sequence variants to mitigate high‑priority liabilities (e.g., substitutions removing labile residues or reducing aggregation motifs).
• Validate top variants via small‑scale expression and analytics for aggregation, PTM profile, stability and activity.
• Advance validated leads with a documented risk‑mitigation plan to reduce surprises and accelerate development.
  

To complement our predictive assessments, we provide tailored engineering programs designed to strengthen candidate performance. These include:

• Deimmunization strategies
• Fc fusion protein design
• Half‑life extension
• Manufacturability improvement
• Removal of high‑risk PTMs
• Reduction of aggregation hotspots
• Stability enhancement
  

Once optimized variants are designed, they can be expressed in customized programs aligned with your therapeutic objectives. This integrated approach allows engineered leads to progress with reduced risk, improved stability, and enhanced clinical potential that helps accelerate development while maintaining quality and manufacturability.

We design and optimize full-length antibodies and fragments to align with human germline frameworks, removing immunogenic regions, and avoiding risky post-translational modifications. Each variant is structurally modeled, expressed, and characterized to help achieve stability, binding affinity, and reduced immunogenic potential. Optional in vitro T cell assays help compare candidates and refine selection.

For deeper immunogenicity profiling, integrate the Epibase® platform’s T cell epitope screening as your early-warning system for unwanted immune responses.