Platform Leadership

GMP iPSC reprogramming, gene editing and differentiation

With experience generating and characterizing over 200 induced pluripotent stem cell (iPSC) lines, OmniaBio can deliver high-quality iPSCs that meet the unique requirements of each client. We offer:

Good Manufacturing Practices (GMP)-compliant reprogramming platforms to produce therapeutic grade iPSC lines
Expertise using a variety of different nucleases and delivery methods, including CRISPR-Cas9, to generate gene-edited iPSC lines with knock-in, knock-out, and single nucleotide polymorphism (SNP) modifications
An optimized screening approach for fast and accurate identification of single-cell clones of interest
Process scale-up for the generation of a variety of differentiated cell types
An In-house analytics platform to enable cell line characterization

Viral vector upstream and downstream process development and optimization for manufacturing

OmniaBio’s experienced process development team is adept at scaling-up lentiviral vector (LVV) production by establishing customized processes that are efficient and reliable. Our goal is to create a reproducible, closed, scalable process, improving upon the current industry standard to generate best-in-class recovery rates in downstream purification. We offer:
LVV production in adherent and serum-free suspension culture
LVV production using packaging cell lines and transient transfection
Closed system processing at each unit operation, including in-process testing
Harvest and clarification steps enabled by scalable filtration technology
A tailored approach to purification through access to a variety of chromatography resins
Optimization of sterile filtration for up to 70 per cent recovery at the 1 L scale

Automated, closed, integrated process development and manufacturing for T-cells and natural killer (NK) cells (e.g., CAR-T, CAR-NK)

OmniaBio is uniquely equipped to pioneer sophisticated solutions to complex and nuanced manufacturing challenges for cellular immunotherapies. We leverage both in-house expertise and key partnerships to solve technical bottlenecks. We offer:

Closed, reproducible, consistent and GMP-ready processes
An integrated team of process development experts and MSAT scientists, to allow for seamless technology transfer
A modular approach that allows for technology-agnostic, custom solutions
Qualified assays for immunotherapies to quantify potency, purity, cell number and viability
Custom assay development for viral vectors, immunotherapies, and PSC-based products