One connected development plan

01

Feasibility

Assess molecule fit and define the target quality profile.

02

Expression strategy

Select the platform route and development mode.

03

Upstream development

Host/cell-line, media, feed and process-mode work.

04

Downstream & analytics

Recovery, purification and characterization.

05

Scale-up & transfer

Documented, transfer-ready process package.

06

Manufacture

Analytical and method development, with 5 L mammalian and 30–1,000 L microbial capacity; 5,000 L planned.

End-to-end microbial

Every stage of a microbial programme, connected

Strain and construct work, fermentation, recovery, purification, analytics, scale-up and transfer are planned as one sequence rather than handed between disconnected teams. Programs may be scoped for GMP or non-GMP manufacture, and specialized capabilities may be delivered through qualified partners.

Discuss a Development Need
End-to-end microbial Strain &constructFermentationPrimaryrecoveryPurificationAnalyticsScale-upTechnologytransfer

Development capabilities

Go deeper on any stage

01

Upstream development

Expression strategy, host or cell-line work, media and process-mode development.

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02

Downstream purification

Primary recovery, capture chromatography and polishing.

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03

Analytics & characterization

Identity, purity, binding, activity and impurity-control methods.

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04

Scale-up & transfer

Non-GMP and GMP manufacturing scale, documentation and site-transfer support.

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Characterization

Characterization capabilities for peptides, proteins and mAbs

SysGene characterizes molecules across primary, secondary and higher-order structure and biological function, with each analytical programme tailored to the molecule class.

Fewer than 40 amino acids

Peptides

Illustration of a peptide chain

MW ~0.5–5 kDa

  • Short linear or simple cyclic chains.
  • Lack tertiary folding; highly flexible in solution.

Analytical focus: Molecular weight and LC-MS purity.

More than 40 amino acids

Proteins

Illustration of a folded protein

MW ~10–100+ kDa

  • Complex folded 3D structures (α-helices, β-sheets).
  • Susceptible to denaturation and aggregation.

Analytical focus: Secondary and tertiary folding, and activity.

Heterotetramer

Monoclonal antibodies

Illustration of a monoclonal antibody

MW ~150 kDa

  • Y-shaped four-chain glycoprotein (two heavy, two light).
  • Complex post-translational modifications (PTMs).

Analytical focus: Glycosylation, charge variants and binding.

The US FDA defines a protein as any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size; a polymer of 40 amino acids or fewer is a peptide.

View the full characterization toolkit

Manufacturing capability

Capacity in Hyderabad

SysGene operates in-house mammalian bioreactor capacity at 5 L scale and microbial fermenters from development scale to 30 L, 100 L, and 1,000 L in Hyderabad, with 5,000 L capacity planned. Programs may be scoped for GMP or non-GMP manufacture, subject to facility, product and regulatory fit. Additional capacity and specialized capabilities may be delivered through qualified partners.

5 LMammalian bioreactors
30 · 100 · 1,000 LMicrobial fermenters
5,000 LPlanned capacity
Gowned operators working among stainless-steel bioprocess vessels in a cleanroom

Discuss a development need

Tell us where you are in the process and we will map the relevant capabilities to your program.

Contact SysGene