Integrated Drug Substance & Drug Product

One Partner. One Quality System. Zero Hand-Off Risks

Explore capabilities

Talk to our biologics team

25 Yrs

9 months

6 bispecifics in journey to clinic

200 mg/mL

125+ clients

From first antigen to GMP batch, one team on your molecule

Choose your modality to see what the programme needs, the route Aurigene runs it on, and the capacity behind each step.

Monoclonal antibodies (mAbs)

Hybridoma, single B-cell and phage display discovery to a developability-screened lead. Cell line development and 10+ g/L titer processes carry it to GMP under one roof.

Bispecific & multispecific antibodies

Format selection, multi-domain construct design and expression tuned for correct chain pairing, with T-cell redirection assays in-house. 6 bispecifics are advancing to the clinic.

Recombinant & complex proteins

Gene to purified protein across CHO, E. coli, HEK293, Pichia and Sf9, including hard-to-express and multi-domain targets, with formulation and analytics into manufacturing.

Immuno-fusion
proteins

Construct and linker design, expression and functional characterisation for cytokine, receptor and Fc fusions, with protein engineering and antibody discovery on one campus.

Antibody-drug conjugates (ADCs)

Antibody discovery for the targeting arm plus in-house bioconjugation, conjugation-ready in 2–3 weeks, with DAR, purity and cytotoxicity characterisation.

Biosimilars

Sequence-based expression and comparability analytics against the reference (variants, glycans, charge, size, stability), carried on a stable-pool-to-GMP route into supply.

Fab & ScFv
fragments

Fragment design, phage display selection and affinity engineering, expressed in E. coli or mammalian systems and ready to build into multispecifics.

Peptides

Peptide design, expression and purification, backed by the same analytical and formulation depth as the antibody and protein platforms.

Why Aurigene for biologics

20KL

Installed Drug Substance Capacity

~10 weeks

Stable Pool

10 g/L

Peak titer via process intensification

12–14 weeks

Downstream Cycle

10L–2KL

Single-use Scale Progression

100% PPQ

Process Performance Qualification success in 4 years

Regulatory experience

Talk to the people who run the science

Talk to Our Expert

Amit Jogi, PhD

Global Head, Biologics Development & Manufacturing Services

Ujwal Kumar Jonnala

Team leader, Bioanalytical R&D,
Biologics CDMO

Akshay Shukla, PhD

Sr. Director Business Development

Testimonials

A key differentiator was Aurigene’s commitment to transparent, proactive communication and willingness to accommodate requests with rapid turnaround. They routinely provided off-cycle updates when requested, held focused review meetings to drive timely decision-making, and proposed well-considered alternative paths forward, all grounded in solid data. This approach enabled informed choices and helped maintain momentum across critical phases of development.

Chief Commercial Officer

Leading Biotech in Diagnostics space

Happy to collaborate with Aurigene for the cell line development of our novel monoclonal antibody. APSL brings in a strong, experienced and dedicated team with in-depth scientific and technical expertise. We appreciate the commitment, professionalism and ease of scientific collaboration.

Dr. Ganesan Karthikeyan

Executive Director, THSTI

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Biologics Services - Concept to Commercial, End to End Integrated CRDMO Partner

Biologics brochure (PDF)

The end-to-end biologics capability in one document. Gated by work email.