Highly skilled staff in all areas required to develop and manufacture high quality and regulatory compliant biologics

Process & Product Development

Comprehensive Analytical Services

Cell Line Development

Cell Culture (Upstream) Process Development

Purification (Downstream) Process Development

Formulation Development

Drug Product Development

Analytical Development

Physicochemical Analytics

HPLC

CE

Compendial

Mass Spectrometry

Biomolecular Analytics

ELISA

Binding Kinetics

(BLI/Octet)

Cell-Based Assays

Residual DNA (qPCR)

Quality & Regulatory

GMP Compliance (21 CFR Parts 210/211/11)

Fully independent Quality department (QA & QC)

Document Control

Training

CMC & Clinical Regulatory

GMP Manufacturing

Upstream Clean Room(ISO 8)

Downstream Clean Room (ISO 7)

200L Bioreactor W/V

Perfusion Process Capable

Single-Use Tech Throughout

Bulk Drug Substance Fill

Supplier & Inventory Management

Clinical Trial Support

Clinical Research Organization (CRO)Vetting and Selection

CRO Bidding

Contract Negotiation

Vendor Management