Subscribe to Newsletter

A Year in Review, A Year in Flux

Twelve months spent covering the raging torrents of the cell and gene therapy space have left me emotionally invested… and anxious

Download the supplement

In the summer of 2021, I was given the helm of The Medicine Maker’s coverage of the cell and gene field. Since then, so much water has passed under the bridge.

I’ve been immersed in the history, status quo, and possible futures of these remarkable therapies. Online and offline, I’ve picked the brains of the vanguard and figureheads of the field, learning their stories and building a more complete picture of advanced therapy and where it is going.

Flicking back through our newsletter archives, I see wave upon wave, strata upon strata of achievements reshaping a steadily expanding landscape. New sites built, new deals inked. Square meters filled in the thousand, currencies spent in the millions and billions, binding companies across continents and oceans. Starts and stutters of trials launched, paused, completed, and shut down following “miracle” cures, tragic deaths, and less dramatic – but still crucial – partial alleviations in human suffering.

One question facing cell and gene therapy that remains a constant – one that we should all care about – concerns cost. For my entire lifetime, the gap between the world’s richest and poorest people has been expanding. And, as that gulf yawns wider, the utopian promise of cell and gene therapies surely means little if only the wealthiest nations and individuals can afford them.

In our weekly cell and gene newsletter (subscribe at, I launched a series called “The Cell and Gene Champions,” in which I pitched thought-provoking questions to the community, sharing the strongest answers. The question closest to my heart was – unsurprisingly – “How do we ensure that not only the rich benefit from cell and gene therapy?”

In this special supplement to The Medicine Maker, you will find thoughts on how we bring cell and gene therapies to the many and not the few – as well as other contributions from our Cell and Gene Champions. You will also gain access to a wealth of additional insight into this high-stakes field from visionaries such as Bruce Levine of the University of Pennsylvania, Miguel Forte of BioSenic, and Marianthi Psaha of Santen.

Perhaps you will walk away from it with your curiosity sated. Perhaps you will be full of nervous energy and eager to learn more. In either case, I will consider my mission accomplished.

Angus Stewart
Associate Editor, The Medicine Maker

Download the supplement


Bio-Rad expertise and GMP-ready technology solutions span every step of cell and gene therapy development and manufacturing. Absolute nucleic acid quantification is the best way to achieve sensitive, accurate characterization of biologic products. Droplet Digital™ PCR (ddPCR™) instruments are incredibly versatile, enabling precise quality control and product characterization with a single tool throughout your entire process.

Custom ddPCR assays and off-the-shelf kits can be applied for a wide range of cell and gene therapy production steps:

  • Plasmid quality analysis
  • Residual host cell DNA detection and quantification for multiple species including HEK293, CHO, and E. coli
  • Mycoplasma contamination detection
  • Transgene copy number quantification
  • Viral titer determination
  • Biodistribution and patient monitoring in clinical trials

Analyze in-process samples and final drug products with the same easy, reproducible workflow to obtain scalability and streamline your bioprocesses. Our experts have years of industry experience and are ready to provide rapid on-site support and scientific consultations.

In recent years, new technologies have emerged to improve human living conditions. Two popular examples are cell therapy, where cells are enriched or modified ex vivo then re‐introduced to the patient, and gene therapy, where genes are introduced, replaced, or altered within the body. Consolidated as cell and gene therapy, both are projected to revolutionize the treatment of genetic or acquired diseases, such as cancer.

In order to further advance the development of these innovative treatment options, Eppendorf has emerged as an expert partner for bioprocess by utilizing its strong synergies in cell culture, bioreactor technology, and polymer manufacturing.

Our bioprocess solutions support the upstream bioprocessing cycle from early development to scale‐up to pilot‐scale production. Powerful hardware and software tools for process monitoring, control, and analytics help to build process understanding and facilitate standardized process control.

Eppendorf and its 5000 employees use their broad knowledge and experience to support laboratories and research institutions around the world in our mission to improve human living conditions.

With our equipment, training programs, and application services, we support scientists in resolving cultivation bottlenecks during development and help to stimulate the growth of your cultures and cultivate solutions tailored to your challenges.

Gene therapies hold the promise to change lives. Even as the path to patients accelerates, manufacturing and regulatory complexity remains a challenge. With limited process templates, evolving regulatory guidance, and urgent patient needs, finding a partner with experience is critical to your success.

From solving your unique upstream and downstream challenges, to meeting urgent manufacturing timelines, and navigating uncertain regulatory guidelines, a knowledgeable partner can help move your gene therapy from hype to hope.

At MilliporeSigma, we’re giving shape to gene therapy development every day. We bring 30+ years of expertise, and a global organization to integrate leading manufacturing technologies with process development, scale-up, safety testing, and the regulatory experience to meet your therapy’s needs.

We have more experience in this area than almost anyone else in the industry. We were the first gene therapy CDMO to produce commercial product following successful regulatory inspection. Our products and services include optimized manufacturing platforms, media and reagents; manufacturing, biosafety and characterization testing, as well as process development services.

Draw on our experience to bring your gene therapies to life.

Gene therapy

Get to know OmniaBio, Canada’s largest CDMO focused on CGT manufacturing

Launched in 2022, OmniaBio Inc. enables focused manufacturing for cell and gene therapies (CGTs), from clinical to commercial scale. As a subsidiary of CCRM, OmniaBio builds on an established reputation built over a decade, with proven expertise in process development and good manufacturing practices (GMP)-compliant manufacturing.

The OmniaBio campus, opening in a scaled launch between 2024- 26, will cover up to 400,000 square feet, making it Canada’s largest contract development and manufacturing organization (CDMO) for CGTs.

Taking a collaborative, extended team-member approach to project management, OmniaBio works with clients to produce a comprehensive manufacturing plan that identifies opportunities to build in efficiencies, saving time and money.

With teams experienced in 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, with GMP-compliant reprogramming platforms to produce therapeutic-grade iPSC lines. OmniaBio is built upon leadership in iPSCs, lentiviral vectors, and immunotherapy – and these are just three of our 11 areas of extensive expertise.

Visit to find out more about our expertise, and how we can support CGT manufacturing projects.

The Gibco™ CTS™ DynaCellect™ Magnetic Separation System enables closed, fully automated, and rapid cell isolation and bead removal for cell therapy manufacturing.

When used with Gibco™ CTS™ Dynabeads CD3/CD28, users can consistently achieve >85% cell isolation with 95% purity, with no effect on viability. Recovery of cells after CTS Dynabeads CD3/CD28 removal is >91%.

The CTS DynaCellect System can process cells in ~100 minutes when used with CTS Dynabeads CD3/CD28, while other instruments may take 4–5 hours. Furthermore, the system shortens bead removal time from ~5 hours to under 1 hour. The combination of shortening cell isolation and bead removal time is key to streamlining the workflow.

The system is also highly scalable, allowing for 10 mL–1 L of reaction volume for cell isolation. The continuous flow process for bead removal means the volume is potentially unlimited. With flexible software for optimal protocol design and a documentation functionality for increased quality control, the CTS DynaCellect System helps ensure manufacturers can move toward commercialization with confidence.

The CTS DynaCellect system combines scalability, flexibility, and automation with high-speed proven performance and modularity, helping cell therapy manufacturers get their essential therapies to the patients quickly.


Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine