Pharmaceuticals & Healthcare
Advanced Biologics (ADC / Biosimilar)
Japan–India sourcing, regulatory and partnership expertise extended to antibody-drug conjugates and biosimilars, backed by manufacturing partners who can take a programme from linker to filled vial.
22
ADC payloads and linkers in the catalogue
2,000 L
Single-use bioreactor scale in our partner network
55 kL
Microbial fermentation per vessel, same network
Overview
The modality is new. The cross-border problem (finding the right partner, translating between Japanese requirements and Indian capability, and staying in the relationship afterwards) is one we have been solving since 1980.
As the pharmaceutical industry moves toward more complex modalities (antibody-drug conjugates and biosimilars among them), we are extending the same Japan–India sourcing, regulatory and partnership expertise that has defined our small-molecule business to this next generation of therapeutics.
The cross-border problem has not changed shape, but it has become harder. A Japanese company evaluating an Indian biologics partner is assessing a manufacturing platform, not a molecule: cell line and process development, conjugation chemistry, analytical characterisation, fill-finish and lyophilisation, and a quality system that will hold up under inspection. Judging all of that from Tokyo, through a language barrier and an unfamiliar regulatory vocabulary, is the real difficulty, and it is the same difficulty we have been resolving in active ingredients for four decades.
Our role is what it has always been. We find and qualify the partner, translate in both directions, and stay in the relationship after the introduction, which is the part that decides whether a cross-border project survives its first problem. What is new is the depth of manufacturing we can now put behind it.
Kyodo works with a number of biologics manufacturers in India on a non-exclusive basis. The deepest of those relationships is with Shilpa Biologics, and it is the one most Japanese enquiries end up drawing on.
A Japanese company evaluating an Indian biologics partner is assessing a manufacturing platform, not a molecule.
Key capabilities
Partner sourcing & qualification
Identifying biologics manufacturers in India whose platform, capacity and quality system genuinely fit the programme in front of them, rather than the one that answered first.
Regulatory translation
Four decades of Japanese submission experience applied to a modality where the documentation burden is heavier and the precedent thinner.
Payload & linker supply
A catalogued supply of cytotoxic payloads and cleavable linkers, orderable by CAS number rather than by open enquiry.
Integrated ADC manufacturing
Antibody, payload, linker and conjugation under one roof, so a programme is not stitched together across three separate supply chains.
Biosimilar development
Mammalian cell culture and microbial fermentation capacity for biosimilar programmes, from cell line through aseptic fill.
Ongoing relationship management
Staying in the project after the introduction: deviations, change controls, audits and the awkward conversations that follow them.
01Working with Shilpa Biologics
Shilpa Biologics operates one of the few genuinely integrated ADC platforms anywhere: antibody, payload, linker and conjugation at a single site, rather than a conjugation service depending on three separate supply chains all arriving on time.
That integration is what changes the economics of a Japanese programme. When the payload, the linker and the antibody sit inside one quality system, a deviation is one investigation rather than three, and a change is one change control rather than a negotiation between vendors. Shilpa states that it supplies approximately 40% of the world's oncology high-potency APIs, and operates a quality management system aligned to USFDA, EMA and WHO standards.
- Conjugation at 50–200 L scale, with expected conjugation yield above 60% at a protein input concentration of 10 g/L.
- Annual effective drug-substance capacity of up to 140 kg after conjugation and purification, with a dedicated ADC facility operational since September 2025 adding up to 15 kg per year.
- Mammalian cell culture in single-use bioreactors up to 2,000 L, with modern aseptic fill lines for vials and prefilled syringes.
- Microbial fermentation up to 55 kL per vessel against 200 kL of cumulative site capacity, suited to E. coli and Pichia at commercial scale.
- Zero liquid discharge, renewable energy and ISO certification on the environmental side.
02What the platform covers
The platform is deliberately hybrid, chemistry and biology inside one organisation, so an ADC programme is not handed between a small-molecule house and a biologics house at its most fragile point. Scope runs from small molecules, peptides and monoclonal antibodies through specialty polymers, payloads and linkers, recombinant technology, and finished antibody-drug conjugates.
Support runs the full length of a programme rather than a single step of it, from basic research through commercial supply.
- ADC process development, with a dedicated team for conjugation and purification.
- Analytical development and characterisation of payloads, linkers and intermediates.
- Chemocatalysis and biocatalysis for scalable synthesis of high-potency payloads and specialty linkers.
- Fill-finish and lyophilisation, including cycle optimisation and stability work.
- Cytotoxic anticancer drug development, from the basic research stage onward.
ADC payloads and linkers
Catalogued by CAS number and available through our partner network. If the molecule you need is not on the list, ask: the list reflects what is held, not the limit of what can be made.
Payloads
| No. | Product name | CAS No. |
|---|---|---|
| 01 | MMAE | 474645-27-7 |
| 02 | VcMMAE | 646502-53-6 |
| 03 | MMAF | 745017-94-1 |
| 04 | Exatecan | 171335-80-1 |
| 05 | Exatecan mesylate | 169869-90-3 |
| 06 | SN-38 | 86639-52-3 |
| 07 | Irinotecan | 100286-90-6 |
| 08 | Topotecan | 123948-87-8 |
| 09 | Topotecan hydrochloride | 119413-54-6 |
| 10 | Methotrexate | 59-05-2 |
| 11 | Docetaxel | 114977-28-5 |
| 12 | DM4 | 796073-69-3 |
| 13 | DM1 | 139504-50-0 |
| 14 | Gemcitabine | 95058-81-4 |
Linkers
| No. | Product name | CAS No. |
|---|---|---|
| 01 | Fmoc-Val-Cit-PAB-OH | 159858-22-7 |
| 02 | Mc-Val-Cit-PABC-PNP | 159857-81-5 |
| 03 | Mal-heptanoic NHS ester | 55750-63-5 |
| 04 | Fmoc-Phe-Lys(Trt)-PAB-PNP | 1116086-09-9 |
| 05 | Fmoc-Ala-Ala-Asn-PAB-PNP | On request |
| 06 | Fmoc-Gly3-Val-Cit-PAB-PNP | 2647914-16-5 |
| 07 | NH2-PEG6-Val-Cit-PAB-OH | 2055024-60-5 |
| 08 | Mal-PEG4-Val-Cit-PAB-OH | 2055041-39-7 |
Kyodo does not manufacture these materials. They are supplied through our partner network, and quantities, lead times and documentation are confirmed per enquiry.