Category: Therapeutics & Vaccines

Manufacturing Breakthrough for mRNA Raw Materials with Aldevron

Posted on by Patrick Boyle

The global biotech community has come together during the pandemic to develop and deliver multiple effective and safe vaccines for COVID-19. However, more than two thirds of the global population has yet to be vaccinated – one way to reach the rest of the world is through enabling more scalable production of the raw materials needed to make vaccines. Today, I’m excited to announce our collaboration with Aldevron, a world leader in manufacturing mRNA vaccines and raw materials. We’ve been working with them since earlier this year to optimize the production of an important component often required to manufacture mRNA vaccines and therapies: the vaccinia capping enzyme (VCE).

Through our collaboration, Aldevron is now able to produce over 10 times more VCE per batch than the previous process, a significant manufacturing breakthrough for this critical component.

Aldevron, who has a successful history manufacturing high-quality components for genetic medicines, has the exclusive rights to the protocol conditions for this newly developed manufacturing process.

When placed in our bodies, mRNA vaccines use ribosomes—the cellular machinery that reads and translates mRNA into useful proteins—to produce a viral antigen. Human mRNA is “capped,” meaning the beginning of the mRNA sequence is modified with a 7-methylguanylate molecule. This specific cap structure needs to be added to mRNA vaccines and therapeutics to ensure the mRNA is recognized by our ribosomes and prevent premature degradation of the mRNA. VCE is a common tool for adding this specific cap structure to mRNA in vaccine manufacturing. However, it’s typically expensive and difficult to produce in mass quantities. In partnership with Ginkgo, Aldevron is working to ensure that there are sufficient quantities of VCE to meet rising vaccine demands.

This manufacturing improvement is an exciting milestone for Ginkgo as we continue to expand the capabilities of our cell programming platform to enable customers in the pharmaceutical ecosystem to improve their products and manufacturing processes. Aldevron has been a great partner with us on improving VCE, which we believe is a key ingredient to scaling mRNA production globally. This breakthrough represents a momentous growth opportunity for them as they continue to bolster their expansive portfolio of products.

Tom Foti, President of Aldevron’s Protein Business Unit, shared his excitement: “I’m very excited about combining the additive strengths of Ginkgo Bioworks’ development expertise and Aldevron’s manufacturing horsepower to yield an optimized manufacturing method for vaccinia capping enzyme. Historically, this enzyme has been difficult to produce, and we believe this yield breakthrough will accelerate mRNA therapeutic and vaccine development for manufacturing teams around the world.”

Supporting COVID-19 mRNA Vaccine Development with Moderna

Posted on by Jason Kelly

There is nothing more critical right now than doing what we can to accelerate potential vaccines, diagnostics, and treatments for COVID-19. We’ve rapidly shifted our entire platform towards COVID-19 response, committing $25M of free access to our infrastructure to projects that can support R&D across a range of applications.

I’m thrilled to announce today that as part of that offer, we will be supporting Moderna with process optimization for key raw materials used in the manufacturing of its mRNA vaccines, including mRNA-1273, Moderna’s vaccine candidate against COVID-19, the first to enter clinical trials. With access to our high throughput automated tools for biological engineering, we hope that we can help Moderna accelerate its plans to improve the efficiency of its upstream manufacturing process. You can read more about Moderna’s vaccine efforts here.

We’re eager to support many more efforts in COVID-19, through DNA synthesis, full genome sequencing of SARS-CoV-2 for epidemiological tracking, scaling of diagnostics, antibody lead optimization, and antigen design for serological testing, vaccine, or therapeutic development, among others. If you have a project that you think we can help accelerate with our platform, please reach out to [email protected].

Improving Living Medicines with Synlogic

Posted on by Jason Kelly

At Ginkgo, we believe that the power to program DNA will transform all industries, making technology more adaptive, efficient, and renewable. Engineering living cells has of course already revolutionized the pharma industry, from insulin-producing bacteria in the 1980s all the way to CAR-T cells today.

A few weeks ago we announced our acquisition of the Warp Drive genome mining platform and a partnership with Roche, using synthetic biology to discover novel small molecule medicines made by bacteria. Today I’m thrilled to announce an expansion of our partnership with Synlogic, who is ushering in a new paradigm for therapeutics, where the bacteria aren’t just making the medicine, they are the medicine.

Synlogic is developing an incredible platform that enables them to program probiotic bacteria to treat many different complex diseases using the power of biology. Living cells have the ability to do what chemicals can’t: they can sense and respond, they can deliver enzymes and small molecules directly where they’re needed, and they can consume and break down potentially toxic molecules before they cause any harmful effects. Today, Synlogic’s pipeline includes strains of E. coli that live in the gut and consume molecules like phenylalanine or ammonia in diseases where patients’ bodies are unable to do this on their own, leading to toxicity and neurological damage if left untreated. They also are working on engineered bacteria that can be injected directly into tumors, sending up signal flares that alert the immune system to attack the cancer cells.

As organism designers, we’re so excited by Synlogic’s vision and we’ve been so inspired by the talent and passion of the team and their ability to program cells to fight so many different diseases. Their expertise is a perfect complement to the work we do programming cells in our foundries and we’ve been collaborating successfully with Synlogic since late 2017. We’ve been thrilled by the promising early results for our first collaborative project that shows how our two companies can work together to accelerate the development of a new living medicine.

Synlogic had developed an early prototype strain for the treatment of a rare metabolic disease that was promising but had room for improvement. In our foundry, we prototyped and screened over 1000 versions of each of the three enzymes in the designed pathway, zeroing in on the sequences with the highest activity in combination. Because of the scale of our foundries to build and test so many strains, we could help Synlogic’s scientists choose the best strains with significantly improved function both in vitro and in vivo. We’ll be sharing all those details and the results from nonhuman primate studies at the SEED conference in a couple weeks.

Based off of the success of our proof of concept partnership and the enormous potential that Synlogic has in therapeutics, today we are excited to announce an expansion of our collaboration to drive new innovation in living medicines through the combined strength of Synlogic’s expertise in drug design and development and Ginkgo’s foundries for biological engineering. We are making a premium equity investment of $80M and beginning a range of new projects, expanding Synlogic’s pipeline and helping accelerate more promising candidates to the clinic.

We see living medicines as the source of many future drugs. Recombinant DNA technology first made it possible to manufacture protein-based drugs nearly forty years ago, and today a large percentage of promising new drugs are biologics. We can only imagine what might be possible in the age of living programmable medicines.

As with many of our partnerships, we’ve also worked with artist Karen Ingram to illustrate the technology and highlight the beauty of living medicines. As you take a closer look, you’ll notice several of important elements that describe the work of Synlogic and Ginkgo’s collaboration: bacteria sensing and targeting various compounds, biofilm formation, and the gut lining in the background.