Page 142 - CW E-Magazine (3-6-2025)

Pharmaceuticals

FULLY INTEGRATED ADC DEVELOPMENT
Shilpa Biologicals adds bioconjugation capabilities

at Dharwad site

Shilpa Biologicals, a Karnataka- pipeline, and includes 200-L single use
based full-service contract develop- bioconjugation reactors and a lyophili-
ment and manufacturing organisation sation capacity of up to 65-kg. Comple-
(CDMO), has opened a dedicated bio- mentary development laboratories will
conjugation suite at its site in Dharwad, provide process development, analytical
Karnataka. Located adjacent to the characterisation, and both early and late-
company’s existing commercial bio- stage scale-up capabilities. For fi nal
logics manufacturing facility, the suite dose requirements, Shilpa’s Hyderabad
is currently undergoing validation and site is equipped with multiple isolator-
is expected to begin catering to clients based fill-finish lines dedicated to
by September 2025. (HPAPI) capacity,” the company said cytotoxic products.
adding that it currently manufactures
The company said it has now joined “approximately 40% of the oncologi- “We are seeing an unprecedented
a select group of global CDMOs cal HPAPIs in use today from its USF- wave of ADC innovation entering clini-
capable of providing clinical and com- DA-approved facilities”. It’s 10 cGMP cal development – yet only a handful
mercial-scale manufacturing across HPAPI suites are equipped to handle of CDMOs globally offer true end-to-
all three-core antibody-drug conjugate compounds with occupational expo- end capabilities. Our co-located ADC
(ADC) components – payloads/linkers, sure limits (OELs) below 0.01 µg/m³ – services – spanning payloads, linkers,
monoclonal antibodies, and bioconju- ensuring safe and compliant proces- antibodies, and bioconjugation – are
gation – and within a single, integrated sing of even the most potent ADC generating signifi cant industry interest,
campus. payloads. especially from US and European bio-
tech companies seeking a single, re-
“The new suite is backed by one of The new multi-client bioconjuga- liable partner to support their journey
the industry’s largest payload and linker tion suite is built to support the man- from discovery to commercial launch,”
libraries, with a multi-ton high-potency ufacture of ADCs and other advanced said Dr. Sridevi Khambhampaty, CEO
active pharmaceutical ingredient bioconjugates progressing through the of Shilpa Biologicals.

COLLABORATION
Lupin and SteinCares ink license and supply deal

for biosimilar in Latin America

Lupin has entered into a license binant humanised IgG1 monoclonal
and supply agreement with Stein- antibody fragment that binds to
Cares, a leading specialty healthcare and inhibits vascular endothelial
company in Latin America, for com- growth factor A (VEGF-A). Its indi-
mercialisation of Lupin’s biosimilar cations encompass the treatment
ranibizumab across Latin America, of patients with Neovascular (Wet)
excluding Mexico and Argentina. Age-Related Macular Degeneration
(AMD), Macular Edema following
Under the terms of the agree- Retinal Vein Occlusion (RVO),
ment, SteinCares will handle all Diabetic Macular Edema (DME),
regulatory filings, registrations and Diabetic Retinopathy (DR) and
commercialisation of Ranibizumab be responsible for manufacturing Myopic Choroidal Neovascularization
in Latin America, while Lupin will the same. Ranibizumab is a recom- (mCNV).

142 Chemical Weekly June 3, 2025

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