Pharmaceutical Technology Editors

On May 25, 2021, The Discovery Labs announced it has signed a foundational lease with the University of Pennsylvania Gene Therapy Program (GTP) that establishes an anchor tenancy for The Discovery Labs’ new 7-million-ft2 life sciences cluster in Philadelphia’s Cellicon Valley.

The terms of the deal include a multi-year lease and over 150,000 ft2 of lab space encompassing two buildings on Discovery Labs’ 1-million-ft2 campus in King of Prussia, Pa. The University’s GTP will, in turn, use Discovery Labs’ suburban campus for a portion of its expanding research operations, which are focused on the development of genetic medicines for rare and orphan diseases as well as acquired and pandemic infectious diseases, such as COVID-19.

Penn Medicine joins GlaxoSmithKline, WuXi Biologics, and The Center for Breakthrough Medicines (CBM) on the biotech innovation campus. The GTP will be adjacent to The Discovery Labs’ 700,000-ft2 Innovation Renaissance campus anchored by other leading healthcare companies and organizations, such as Thomas Jefferson University Health, Children’s Hospital of Philadelphia, Amerisource Bergen/World Courier, and Tosoh Biosciences. The campus is located near the recently acquired 660,000-ft2 Philadelphia Inquirer printing plant that will be converted into life science research and manufacturing facilities.

The facility expands the GTP’s available space for vector operations, including two dedicated floors for the expanded Penn Vector Core, a full-service viral vector core facility that produces viral-based vectors for gene transfer for researchers both within and outside of Penn. The Penn Vector Core has deep expertise in state-of-the-art vector technology for basic research applications that advance understanding of gene function and the development of therapeutic vectors.

The new space will support discovery research all the way through to submission of investigational new drug applications for clinical trials. In addition, there will be increased capacity for non-clinical proof-of-concept research, large-scale vector production activities, expanded high-throughput research manufacturing for pre-clinical projects, platform development and process optimization, assay development and qualification, quality control testing, and technical transfer.

The lease agreement was led by James M. Wilson, MD, PhD, director, Gene Therapy Program and Rose H. Weiss, professor and director, Orphan Disease Center, and professor of Medicine and Pediatrics, Department of Medicine at the Perelman School of Medicine at the University of Pennsylvania.

“[Wilson] and his incredible team at Penn have helped establish Philadelphia as a leader in gene therapies, and we are deeply honored to have the opportunity to work with him and his incredible team of scientists through the expansion of their world-class research and development labs,” said Brian O’Neill, founder and chairman, The Discovery Labs, in the press release. “To welcome Penn’s Gene Therapy Program as the anchor tenant for our planned life sciences cluster here in King of Prussia is strong validation for the incredible life science ecosystem that is emerging in Greater Philadelphia.”

“The past few years have been a pivotal time in the development of gene therapies, and our new space at Discovery Labs will propel us even further in charting the future of the field,” Wilson said in the press release. “With additional state-of-the-art equipment and increased operational capabilities, we are well-positioned to enhance the design and execution of our innovative, transformative therapies.”

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The Discovery Labs has signed a foundational lease with the University of Pennsylvania Gene Therapy Program to build a new life sciences cluster in King of Prussia, Pa.

The Discovery Labs Secures Pennsylvania Location for New Life Sciences Cluster

Moderna and Aldevron, a provider of high-quality plasmid DNA, messenger RNA (mRNA), and recombinant proteins necessary for vaccines, gene and cell therapy, gene editing, and diagnostic applications, announced on May 24, 2021 that they have expanded their collaboration in support Moderna’s COVID-19 vaccine program and additional programs in Moderna’s clinical development pipeline.

Under the expanded agreement, Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline. Production of DNA takes place in Aldevron’s 70,000-ft2 good manufacturing practice (GMP) facility in Fargo, ND. Buildout and validation of an additional 189,000 -ft2 expansion to the GMP facility on Aldevron’s campus has been completed, enabling additional manufacturing capacity.

“Aldevron has been a long-standing partner of Moderna. We appreciate their collaboration and their expertise in the biologics space,” said Juan Andres, chief Technical Operations and Quality officer of Moderna, in a company press release. “We look forward to our ongoing work with this expanded partnership.”

“Aldevron’s support of the Moderna pipeline spans nearly a decade, and we’re incredibly proud of the trust they’ve placed in us,” said Kevin Ballinger, CEO of Aldevron, in the press release. “Our deep experience, coupled with enhanced operational efficiencies and recent capacity expansion, places us in an excellent position to support Moderna’s efforts—especially during this critical time. We look forward to expanding our strategic partnership to serve a pipeline of important new programs in the future.”

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Moderna and Aldevron Expand Partnership for mRNA Vaccine and Therapeutic Pipeline

Biogen and Ginkgo Bioworks, a US-based bioengineering company, have entered into a gene therapy collaboration worth up to $120 million, under which they will develop a next-generation manufacturing platform to product recombinant adeno-associated virus (AAV)-based vectors, the companies stated in a May 21, 2021 press release.

Under the agreement, Biogen will receive access to Ginkgo’s proprietary cell programming platform and capabilities, and Ginkgo will receive an upfront payment of $5 million as well as eligibility for milestone payments up to an additional $115 million should the collaboration programs achieve certain research, developmental, and commercial milestones. Ginkgo will use its bioengineering facilities and resources to enhance the AAV production titers of Biogen’s gene therapy manufacturing processes.

Currently, manufacturing of recombinant AAV-based vectors is time-consuming and expensive, making it difficult to develop therapies for diseases with high dose needs and with large patient populations. Ginkgo seeks to solve these challenges by applying its mammalian cell-programming platform and aims to improve the efficiency of AAV-producing plasmid vectors and cell lines, which could accelerate Biogen’s development of novel gene therapies, Ginkgo said in the company press release.

“We believe that Ginkgo’s unique combination of cell programming expertise, proprietary tools and knowledge of biological systems make them an ideal collaboration partner to explore a large number of design ideas with the goal of optimizing constructs,” said Alphonse Galdes, PhD, head of Pharmaceutical Operations and Technology at Biogen, in the press release. “They share our goal of ensuring approved therapies are not delayed by manufacturing constraints and are available to patients worldwide.”

“We are excited to collaborate with Biogen as they aim to develop treatments that may potentially slow, halt, or cure neurological and neurodegenerative diseases and seek to enhance the industry standard for AAV manufacturing,” said Jason Kelly, CEO of Ginkgo Bioworks, in the press release. “Synthetic biology is leveraging the power of living cells to develop the next generation of therapeutics, everything from CAR-T [chimeric antigen receptor T-cell] to CRISPR [clustered regularly interspaced short palindromic repeats] and gene therapies, which we believe will have a material impact on the lives of many.”

Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.

Biogen and Ginkgo Bioworks in $120-Million Deal to Develop Novel Gene Therapy Manufacturing Platform

Codagenix, a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, and Univercells, a global life sciences company specializing in next-generation bioprocessing technologies, have entered into a research collaboration agreement to pursue the development of an undisclosed, high-priority human vaccine target with global public health demand.

Under the agreement, the partners will use Codagenix’s synthetic attenuated virus engineering (SAVE) platform, which offers safe, synthetic, live-attenuated virus vaccine development, and Univercells’ viral vaccine process development and manufacturing capacity, which is operated by Exothera, its contract development and manufacturing organization, the companies announced in a May 20, 2021 company press release.

Codagenix is developing a live-attenuated vaccine against an undisclosed, high-priority target, for which it has successfully developed codon-pair deoptimized, attenuated virus cultured in Vero cells. With the agreement, Univercells will assess Codagenix’s vaccine candidate in Univercells Technologies’ (a Univercells company) scale-X bioreactor system, a single-use bioreactor designed to deliver intensified production of viral products by relying on a novel structured fixed-bed design.

Commercial production will later be feasible in Unvercells’ NevoLine upstream manufacturing platform, which uses Univercells Technologies’ latest equipment and is designed to enable the scalable production of viral vectors. The manufacturing platform offers high production throughput and lower long-term operational costs, according to Univercells in the press release.

“Univercells’ viral vaccine manufacturing capabilities are the perfect fit for Codagenix as we expand our portfolio of vaccines developed using our SAVE platform, which utilizes a computer algorithm to recode the genomes of viruses and construct live-attenuated vaccines. This proprietary system enables Codagenix to transform a dangerous viral pathogen into a safe vaccine or solid-tumor therapeutic,” said J. Robert Coleman, PhD, CEO of Codagenix, in the press release. “Like COVIVAC, our single-dose, intranasal, live-attenuated vaccine against SARS-CoV-2, we believe the vaccine candidate now partnered with Univercells is well-positioned to address the shortcomings of existing interventions against a deadly global health challenge and—if successful—ensure large-scale availability at an affordable price.”

“Codagenix has identified what could be a highly potent vaccine against a high-priority disease target with persistent global public health demand. We believe this vaccine is ideally suited for production via Univercells’ proprietary manufacturing system and welcome the opportunity to work with Codagenix to advance its development,” said Hugues Bultot, CEO of Univercells, in the press release.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

Codagenix and Univercells Collaborate on Vaccine Research for Undisclosed Target

On May 25, 2021, the United Kingdom’s Competition and Markets Authority (CMA) launched an anti-competition investigation into AstraZeneca’s $39-billion 

“[CMA] is considering whether it is or may be the case that this transaction, if carried into effect, will result in the creation of a relevant merger situation under the merger provisions of the Enterprise Act 2002 and, if so, whether the creation of that situation may be expected to result in a substantial lessening of competition within any market or markets in the United Kingdom for goods or services,” CMA said in a statement.

CMA is currently accepting written comments regarding the December 2020 transaction until June 3, 2021.

CMA has launched an anti-competition investigation into AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals. 

CMA Launches Anti-Competition Investigation into AstraZeneca’s Alexion Acquisition

MilliporeSigma announced on May 26, 2021 that it has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.

The lipid, which is used in commercially marketed products, is more than 99% pure, provides high batch-to-batch consistency, and is scalable under commercial good manufacturing practices, according to a company press release.

“Tapping into two decades’ experience of developing and manufacturing high-quality lipids, we designed a proprietary process to bring our new SAFC synthetic cholesterol product to market nearly a year early,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma, in the press release. “With the introduction of our new SAFC synthetic cholesterol product, we have increased our capacity by 50 times, helping biomanufacturers bring lifesaving therapies to patients faster.”

MilliporeSigma has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.