We independently develop future biosimilar assets through pre-defined
stages and out-license these programs to clinical and commercial partners.
By strategically prioritizing our portfolio and initiating asset development up to
10 years prior to loss of exclusivity, our partners can delay their decision to pursue
a program enabling additional market and competitive analysis prior to commitment.
We rely on industry leading cell lines and validate our manufacturing processes with
robust analytical tools, significantly de-risking the decision to move an asset
towards commercialization.
Industry-leading cell lines are screened to select clones with highest titer and representative PQ to the reference product. By initiating cell line development early, future biosimilars can be de-risked via understanding of early analytical and safety profiles of the product prior to process development initiation.
Our upstream development efforts use robust small-scale bioreactors to quickly and cost effectively screen media, feed, and bioreactor conditions. Using high-throughput analytical readouts, we make sure to understand the effects on product quality at every stage of development, starting at 15 mL microbioreactors, to 3L glass, to 50L SUB, and through a 200L IND-enabling production run.
Our downstream scientists screen commercially available resins to clear both product and process specific impurities. The finalized 2 or 3 step process will meet commercial production demands for yield and purity.
| Program Name | Modality | Transfection(s) | Clone Selection | Process Development |
|---|---|---|---|---|
| SMB-001* | IgG4 | 3.7 g/L | 4.4 g/L | |
| SMB-002* | IgG4 | 4.5 - 8.0 g/L | 5.9 g/L | |
| SMB-003 | IgG1 | 7.5 - 8.0 g/L | ||
| SMB-004** | IgG1 | 3.0 - 5.0 g/L | ||
| SMB-005** | IgG1 | 3.0 - 4.0 g/L | ||
| SMB-006* | IgG1 | 3.0 - 6.0 g/L | ||
| SMB-007 | IgG1 | 1.4 - 2.7 g/L | ||
| SMB-008* | Bispecific | 5.9 - 9.9 g/L | ||
| SMB-009 | IgG4 | 4.3 - 5.1 g/L | ||
| SMB-010 | IgG1 | 1.9 - 5.4 g/L | ||
| SMB-011 | IgG1 | 2.2 - 3.7 g/L | ||
| SMB-012** | IgG1 | 2.2 - 3.3 g/L | ||
| SMB-013 | Fc Engineered IgG1 | 4.8 - 6.4 g/L | ||
| SMB-014 | IgG1 | 1.4 - 2.0 g/L | ||
| SMB-015 | IgG4 | 3.0 - 6.0 g/L | ||
| SMB-016 | IgG1 | 3.4 - 6.2 g/L | ||
| SMB-017 | Fc Fusion | |||
| SMB-018 | IgG1 | 3.0 - 5.1 g/L | ||
| SMB-019 | IgG1 | 1.5 - 4.5 g/L | ||
| SMB-020 | IgG1 | 4.1 - 4.8 g/L | ||
| SMB-021 | IgG4 | |||
| SMB-022 | IgG1 | 2.3 - 2.5 g/L | ||
| SMB-023 | IgG1 | 4.3 - 4.4 g/L | ||
| SMB-024 | IgG1 | |||
| SMB-025 | Enzyme | 0.9 - 1.2 g/L | ||
| SMB-026 | IgG1 | 1.3 - 2.6 g/L | ||
| SMB-027 | IgG1 | |||
| SMB-028 | IgG4 | |||
| SMB-029 | IgG2/IgG4 | |||
| SMB-030 | IgG1 | |||
| SMB-031 | IgG4 |
1280 N. Mathilda Ave
Sunnyvale, CA 94089
United States
+1 408 543 8800
partner@similis.bio
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