cell therapy Archives - Medical Design Sourcing

AstraZeneca invests $300 million to establish new cell therapy manufacturing facility in Maryland

AstraZeneca facility in Maryland

Maryland Governor Wes Moore announced that AstraZeneca would invest $300 million to construct a new manufacturing facility in Rockville, a city with roughly 70,000 inhabitants that is about 17 miles from Washington, D.C. The facility will focus on cell therapies for cancer treatment. The 84,000 square-foot facility, slated for completion in 2026, will enable global clinical trials and commercial supply of AstraZeneca’s CAR-T cancer therapies. AstraZeneca estimates the plant to create 150 new high-skilled jobs.

Incentives played a role in new plant

To support AstraZeneca’s new manufacturing facility in Rockville, Maryland, the state and county are providing financial incentives, including a $500,000 conditional loan from the Maryland Department of Commerce’s Advantage Maryland program and a $100,000 conditional grant from Montgomery County’s Economic Developm…

What’s next for biotech? Q4 2023 funding trends point beyond the usual suspects

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Oncology may continue be one of the hottest sectors across the pharma sector, but other therapeutic areas are catching up in terms of innovation and investment. While oncology and hematology jointly accounted for about one-third of the new FDA approvals in 2023, investors are increasingly betting on precision medicine, advanced drug delivery systems and the use of AI and machine learning for drug discovery and development.

The shift is not entirely new. In a report from late 2023, McKinsey also notes ML-enabled drug discovery, cell therapies, and gene editing continue to attract significant funding, making up over two-thirds of biotech VC deals in 2022, constituting $15.5 billion in total. The consultancy also noted that immunology had displaced oncology as the hottest therapeutic area for asset-based biotech investments, also citing allogeneic cell therapies …

50 of the best-funded biotechs of 2023

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As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other segments. The next popular two niches, gene therapies and oncology, had average funding levels of approximately $245 million and $170 million, respectively. While AI has received a significant amount of attention this year, biotechs specializing in that field garnered an average funding of only about $66 million. Outside of the life sciences, startups with a broader focus on AI raised a cumulative average of $202.47 million, based on an analysis of close to 1000 companies.

Caris Life Sciences has raised nearly $1.7B to date

In terms of best-funded companies overall,…

Cellares teams up with Bristol Myers Squibb to explore automated CAR-T cell therapy manufacturing

Less than a week after announcing that it has secured $255 million in Series C funding, South San Francisco-based startup Cellares has revealed that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program. To date, the company has raised more than $355 million in total financing.

As part of the TAP program, Bristol Myers Squibb plans on conducting a proof-of-concept transfer of a CAR-T cell therapy process onto the Cell Shuttle, which the company has called a “factory in a box.”

Cellares plans to use the funding to launch what it dubs the world’s first commercial-scale Integrated Development and Manufacturing Organization (IDMO) smart factory. Koch Disruptive Technologies led the investment round, which included participation from Bristol Myers Squibb, DFJ Growth, Willett Advisors, Eclipse, Decheng Capital and 8VC.

When asked how Cellares managed to receive a large funding round in a difficult financial climate, Gerlinghausen sa…

Development challenges and regulatory changes for cell and gene therapies

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Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But cell and gene therapies also have unique characteristics that can lead to manufacturing challenges and extended regulatory timelines. As of February 2020, cell and gene therapies account for 12% of the preclinical pipeline and 16% of the clinical pipeline.

Given the scale of investments made to support these development efforts and advancements possible, drug sponsors have looked to the U.S. FDA to consider accelerating gene and cell therapy development. The regulatory body has responded by shifting its departmental structure to st…

Prominent cell and gene therapy vendors in 2023

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In recent years, the cell and gene therapy market has grown at a rapid clip. The momentum is likely to continue. According to Vision Research Reports, the global cell and gene therapy market size could hit around $42.56 billion by 2030, growing at a CAGR of 39% from 2022 to 2030.

The burgeoning demand in the industry, along with an increasing number of FDA-approved therapies, is also fueling the growth of cell and gene therapy vendors offering tools and services for product development and manufacturing.

The following table includes notable vendors and suppliers active in the call and gene therapy marketplace. This curated selection of companies includes a brief overview of their focus areas.

We have a separate feature focused on companies with prominent cell and gene therapy development efforts.

Company Name Description Notable partnerships Founded He…

How Cellares aims to transform cell therapy manufacturing

The startup Cellares has a mission to enable industrial-scale cell therapy manufacturing with its Cell Shuttle, which it dubs a “factory in a box.”

The germ for the idea traces back to market research that South San Francisco, California-based Cellares co-founder and CEO Fabian Gerlinghaus focused on in a prior role. While attending industry conferences, Gerlinghaus stumbled upon traditional cell therapy manufacturing challenges and the opportunity to accelerate the process. “At these conferences, people were shouting from the rooftops, ‘We need cell therapy manufacturing technologies that are fully automated, fully closed and scalable to produce these life-saving therapeutics at a large scale for all the patients who need them,'” Gerlinghaus recounted.

Fabian Gerlinghaus

Cellares was born in April 2019 and has raised $100 million to date.

One of the chief objectiv…

‘Freeze-Lock’ cryo label supports the needs of frozen medications

The Freeze-Lock cryo label from Schreiner MediPharm (Oberschleissheim, Germany) is suited for mRNA-based vaccines. The labels also support many cell and gene therapy medications and clinical trials, given their ability to withstand subzero storage and transport temperatures required by pharmaceutical and biopharmaceutical manufacturers and clinical researchers.

Schreiner MediPharm notes that conventional labels fail to offer consistent adhesion. The company’s Freeze-Lock cryo label comprises two interlocking label layers to optimize for adhesive strength and product information readability.

The label includes two components: a bottom and a top label.

The bottom label layer has a microfine surface texture that bonds to a container at room temperature. After being filled with the active ingredient, the label is ready to be stored at subzero temperatures requiring dry ice (–78 °C/–108.4 °F) or liquid nitrogen (–196 °C/–320.8 °F).

The top label layer …