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Sureness Biosimilar Platform

One-Stop CDMO Service for Biosimilars

The Sureness Biosimilar Platform is an end-to-end CDMO service dedicated to biosimilar development. It supports a program from reference product sourcing through IND filing, covering cell line development, cell culture media and process development, purification, formulation, analytical comparability, and GMP drug substance and drug product manufacturing. Media development and CMC execution are delivered by the same organization, so when a critical quality attribute falls outside the reference product range, the team adjusting the media is already accountable for the program.

Stable cell line development for biosimilars
What the Platform Covers

From Reference Lot to IND and Beyond

The platform runs as one continuous program with a comparability strategy built in from the early stages. This results in a streamlined process that gets you to IND filing with the FDA in 9-12 months. 

1. Reference Product Assessment and Optional Sourcing

  • Optional reference product lot purchases on your behalf 
  • Reference product details, such as sequences and critical quality attributes, are evaluated up front

2. Biosimilar Development

  • Cell line development
  • Upstream and downstream process development
  • Cell culture media optimization
  • Formulation development
  • Analytical development

3. GMP Manufacturing

  • GMP cell banking (MCB/WCB)

  • Drug substance and drug product manufacturing

4. Stability and IND Filing

  • Stability studies

  • Support for IND filing and beyond

Analytical Similarity is Built Into the Process Early On

Most programs treat comparability as a gate at the end of development. That is where surprises become expensive. A charge variant profile discovered out of range after process lock-down means re-development, not re-analysis. We build analytical similarity into the process from the start, using a four-step strategy.

Four-Step Analytical Similarity Strategy

Steps What Happens
Define the reference target  Characterization of reference product establishes the target quality profile before any development decision is made. 
Design toward similarity  Cell line, media and process are selected and optimized against that target. 
Demonstrate analytical similarity  Orthogonal structure and function assays as well as other criteria-acceptance tests are developed and tested.
Resolve residual uncertainty  PK/PD, immunogenicity or clinical data only where scientifically needed. 

 

Project Showcase

From <2 g/L to a 2-Fold Titer Boost and A Comparable Process at 500 L 

A client came to us with an existing process yielding under 2 g/L and a requirement that the new process remain comparable to the original reference standard.

After three development rounds completed in two months, the titer increased from <2 g/L to 5.3 g/L. An eight-additive screen also tuned the N-glycan profile onto target, and a process lock confirmed the results at 10 L.

At 500 L GMP scale, two drug substance lots delivered 5.93 g/L and 5.61 g/L with charge variant and N-glycan profiles closely matching the original reference standard.  

Titer after 3 development rounds
1.  Titer improved from <2 g/L to 5.3 g/L after three rounds of development. 
Case study CQA
2. Critical quality attributes of the original process and post-optimization. 
Titer at 500 L scale
3. Titer of two drug substance lots at 500 L GMP scale, with run 1 at 5.93 g/L and run 2 at 5.61 g/L, demonstrating consistency from small to large scale.
Case study CQA - 500 L run
4. Charge variant and N-glycan profiles of the drug substance lots matching closely to the original reference standard.

Why Biosimilar Developers Choose the Sureness Platform

Cell Culture Media Development and CMC Under the Same Roof

Most biosimilar programs buy media from one company and CMC execution from another, which can easily create a disconnect. On the Sureness platform, they are the same team, so when comparative analytical assessment flags a difference, media and process optimization is an in-house iteration, not a change order with a new vendor and a new timeline

Depth in Biosimilar Comparability

We have completed comparability-related projects that span mAbs, glycoproteins, enzymes and other complex modalities. This includes 70+ cell culture media development programs that modulate CQAs toward reference products.

Regulatory Submission Experience in More Than One Market

We build regulatory considerations into a program from the earliest stage, so developers have support from day one. This approach has helped support 60+ approvals across multiple biologic modalities and countries, including the United States and China.

FAQ

What is the Sureness Biosimilar Platform?

The Sureness Biosimilar Platform is the end-to-end biosimilar CDMO service from OPM Biosciences, delivered through its subsidiary Sureness. It covers the full program from optional reference product lot purchase and analysis, through cell line development, media and process development, formulation, analytical comparability and GMP drug substance and drug product manufacturing, to IND filing support. Its distinguishing feature is that cell culture media development and CMC execution sit in the same organization, so quality attribute problems are solved by the team accountable for them.

 

How long does biosimilar development take to reach an IND?

A representative mAb biosimilar CMC program reaches an FDA IND in 9-12 months on this platform. That covers reference product assessment, stable cell line development, MCB/WCB banking, cell culture and process development, formulation, analytical method development and validation, GMP DS and DP manufacturing, biosimilarity study, and IND application support. Stability studies continue beyond the filing. Actual timelines vary with molecule complexity, host system and target market.

 

How many reference product batches do I need for a biosimilar IND?

It depends on the market. The FDA expects 2–3 candidate drug batches and at least 3 reference product batches for an IND application. The EMA has no specific guideline requirement at IND stage, but enough batches must be available to characterize the reference product’s quality attribute ranges.

Can cell culture media actually change a molecule’s critical quality attributes?

Yes. Media and feed composition directly influence N-glycan profile, charge variant distribution and aggregation — three of the attributes that carry the most weight in a comparative analytical assessment. Other factors that can impact CQAs include culture temperature, pH, etc.

 

What host cell lines do you work with?

CHO-K1 (ATCC or ECACC), CHO-S, CHOZN and CHO-DG44, among others. Our experience also spans mAbs, bispecific antibodies, Fc-fusion proteins, glycoproteins, enzymes, etc.

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