Our Locations

The Shanghai headquarter was established in 2006. Professional team dedicated to the process development of small molecule, payloads, linkers and oligonucleotide, analytical chemistry laboratories and QC/QA. With the support of a vast building block library, we have served global clients with process development and manufacturing of APIs and advanced intermediates from exploratory medicinal chemistry research, drug discovery and preclinical development, clinical development to commercialization.

The Shanghai R&D Center focuses on the formulation CMC service. The R&D and GMP kilo lab facilities is about 41000 ft². With more than 20 years of dedicated CMC experience, 2Y-Chem has served more than 200 NME projects worldwide, ranging from preclinical, clinical to commercial stages.

•        Total area: ~155,000 ft²
•        5 GMP HPAPI production lines (OEB5, OEL 0.01μg/m³ ) with a total volume over 8,000L
•        2 API GMP kilogram scale production line; 6 Class D clean room in total, scale up to          kilograms (commercial scale)
•        Multiple negative pressure isolators, prep-HPLC and Lyophilizers
•        Compliant with FDA/EMA/NMPA regulatory standard, passed 1 EU QP audits

•        Total area：~945,000 ft²
•        Number of reactors: ~170, range from 100L-8,000L
•        Total reactor volume：~483,000L
•        Reactions: Hydrogenation reaction, Grignard reaction, oxidation reaction,           photoreaction, high temperature reaction(240°C) and deep cryogenic           reaction(-80°C)

•        Total area：~1,134,500ft²
•        ~50 reactors range from 500L - 5,000L, total reactor volume is ~115,000L , Scale up to           hundreds of kgs per batch；

•        Total area：~146,390 ft²
•        8 Independent Class D manufacturing area
•        Oral solid dosages：4 commercial-scale plants，~1 billion units per year；
•        Semi-solid topical dosages ：3 commercial-scale plants，~50 million tubes per year
•        Solid dispersion: a large scale topical preparation line
•        Dosage form：tablets, hard capsules, granules, powder, cream, ointment, gel
          and anti-tumor drugs
•        passed 3 EU QP audits, 1 Indonesian BPOM GMP Compliance Inspection 

Total Area：~600,000ft²
Production lines:
•        1 Antibody Line: 200L, 500L, 2000L, reserve a number of 2000L production line ;
•        1 Conjugation/ADC DS Line: 5L, 20L, 50L, 100L, 200L, 500L
•        1 DP filling Lines  (with Lyophilizer) :10m², 25m²
Production capacity:
ADC DS: 1500kg/year ; ADC DP: 5 million bottles/year
XDC types:
PDC, RDC, DAC, AOC, etc.