Syracuse Bio Campus (New York, USA)

Overview

Comprehensive end-to-end biologic drug substance manufacturing capabilities, including an on-site cell bank facility and cryogenic storage of drug substance

Designed to support concurrent manufacturing of multiple products with minimal product change over time

Robust manufacturing support services onsite including end-to-end MS&T* capabilities, procurement, quality assurance & control, environmental, health and safety, engineering, and enabling functions such as HR and finance * MS&T = Manufacturing Science and Technology

Regulatory compliance track records with over 62 approvals by Health Authorities worldwide including FDA, EMA, PMDA and MFDS

Production Capacity

Inoculation Suites x3

5,000L Stainless
Steel Bioreactors x8

Purification Suites x2

Cell Banking and Inoculum

• Cell banking capabilities to support the following Cell line development along with clinical and commercial cell banking Liquid nitrogen storage of cell banks in vapor phase at -190 °C and storage capacity of 36,500 vials

• Storage Capacity Cryogenic Storage 5,460 x 10L Bottles Dedicated Cryogenic Storage Building Five -40℃ Walk-in freezers

• Inoculum capabilities Three inoculation suites, each equipped with a biosafety cabinet and incubators, capable of enabling product segregation and avoiding cross-contamination Flexible design to accommodate single-use system and cleanable / reusable equipment

List of Current Equipment for Process and Analytical Development

• Analytical HPLCs, UPLCs ÄKTA Avant Densitometer, UV/Vis spectrophotometers (CARY 60, SoloVPE®, NanoDrop), Mass spectrometers PCR system (Quant Studio™) Automated ELISA systems, Plate Reader, Plate washers iCE3™, BIAcore™, Gly-Q™ Glycan analysis system Particle size analyzer, TOC analyzer

• Upstream Vi-CELL Cell Viability Analyzers Nova BioProfile® FLEX Analyzers Roche Cedex Bio HT Analyzer Incubator shakers WAVE™ Cellbag™ 25 bioreactors 5L, 20L Bench-scale bioreactors 0.1 – 100L Stainless Steel and Single-Use mixers

• Downstream ÄKTA Pilot Automated Liquid Chromatography Tangential Flow Filtration (TFF) systems UV/Vis spectrophotometers (CARY 60, NanoDrop, SoloVPE®) Viscometer

• Storage -40 to -80°C Freezers Walk-in cold room (2-8°C) Cryogenic freezers and nitrogen dewars

Expansion Plans