Service Introduction
Sinopep's elite CMC team offers end-to-end support, steering projects from conception to market launch seamlessly. With tailored solutions, industry-leading expertise, and a commitment to excellence, we ensure meticulous guidance and regulatory compliance, accelerating your product's journey to success.
Oligonucleotide NCEs
Our oligonucleotide CRDMO platform located in “China Biopharma Town” in Hangzhou city. This R&D center and fully GMP compliance pilot plant facility is equipped with top-of-the-line oligo synthesis and purification equipment from Cytiva. Meanwhile, our corresponding analytical service platform is equipped with the cutting-edge analytical instruments such as QE Plus Orbitrap, XEVO G3 QTof, Maldi-Tof, Circular Dichroism, and ICP-MS etc. to perform structure elucidation of highly complexed oligonucleotide structures and carry out extremely challenging studies about impurities associated with these type of drug candidates. There are more than 60 scientists in this organization and over 50% of the team members has advanced graduate degrees and with relevant industrial experience in this field. We have collaborated on with multiple domestic and international partners on ASO (antisense oligonucleotides), SiRNA, PMO, as well as various types drug conjugates.
Synthetic Small Molecules
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Project Code
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Project Type
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Classification
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Status
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AT008CDMO (ANDA)SiRNAProcess development and optimization
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AT017CDMO (ANDA)SiRNAProcess development (Lab scale)
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AT018CDMO (ANDA)SiRNAProcess development (Lab scale)
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AT019CDMO (ANDA)SiRNAProcess development (Lab scale)
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AT030CDMO (NDA)SiRNAToxicology batch
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AT041CDMO (NDA)SiRNAProcess development (Lab scale)
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AT005CDMO (ANDA)ASOEngineering batch
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AT003CROASO,vaccine adjuvantProcess development (Lab scale)
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AT035CROASO,vaccine adjuvantProcess development (Lab scale)
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AT037CROASO,vaccine adjuvantProcess development (Lab scale)
Production Equipment
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Synthesis
OligoSynt*3
Unique AutoOligo100*2
OligoPilot
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Purification
ÄKTA Avant25*1
ÄKTA Avant150*1
ÄKTA Pilot600*1
ÄKTA Process*1
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UF / DF / TFE
ÄKTA Flux6*1
Uniflux 10*1
Uniflux 30*1
Thin Film Evaporator (CEP-Lab, CEP-1S)
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Lyophilization
Scientz Lyophilization (0.5㎡)
Truking Lyophilization (5㎡)