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TriLink BioTechnologies® Announces New San Diego Facility for Late Phase mRNA Drug Substance Production

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TriLink BioTechnologies, a Maravai LifeSciences company (NASDAQ: MRVI), announces the opening of a new cGMP mRNA manufacturing facility in San Diego. The facility is designed to support late-phase drug developers and meet the increasing demand for mRNA-based medicine. With state-of-the-art equipment and increased manufacturing capacity, the facility aims to advance the field of mRNA therapeutics.
TriLink BioTechnologies, una società di Maravai LifeSciences (NASDAQ: MRVI), annuncia l'apertura di un nuovo impianto di produzione di mRNA cGMP a San Diego. L'impianto è progettato per supportare gli sviluppatori di farmaci in fase avanzata e soddisfare la crescente domanda di medicina basata su mRNA. Dotato di attrezzature all'avanguardia e una maggiore capacità produttiva, l'impianto mira a promuovere il campo della terapeutica a base di mRNA.
TriLink BioTechnologies, una compañía de Maravai LifeSciences (NASDAQ: MRVI), anuncia la apertura de una nueva instalación de fabricación de ARNm cGMP en San Diego. La instalación está diseñada para apoyar a los desarrolladores de fármacos en etapas finales y cubrir la creciente demanda de medicina basada en ARNm. Con equipos de última generación y una capacidad de fabricación aumentada, la instalación tiene como objetivo avanzar en el campo de la terapéutica de ARNm.
마라바이 라이프사이언스(Maravai LifeSciences)의 자회사인 트라이링크 바이오테크놀로지스(NASDAQ: MRVI)는 샌디에이고에 새로운 cGMP mRNA 제조 시설을 개장한다고 발표했습니다. 이 시설은 후기 단계의 약물 개발자를 지원하고 mRNA 기반 의약품에 대한 증가하는 수요를 충족시키기 위해 설계되었습니다. 최첨단 장비와 증가된 제조 능력을 갖춘 이 시설은 mRNA 치료 분야를 발전시키는 것을 목표로 하고 있습니다.
TriLink BioTechnologies, une entreprise de Maravai LifeSciences (NASDAQ: MRVI), annonce l'ouverture d'une nouvelle installation de fabrication d'ARNm cGMP à San Diego. L'installation est conçue pour soutenir les développeurs de médicaments en phase avancée et répondre à la demande croissante de médicaments à base d'ARNm. Dotée d'équipements à la pointe de la technologie et d'une capacité de fabrication accrue, l'installation vise à faire avancer le domaine des thérapeutiques à base d'ARNm.
TriLink BioTechnologies, ein Unternehmen von Maravai LifeSciences (NASDAQ: MRVI), kündigt die Eröffnung einer neuen cGMP mRNA-Herstellungsanlage in San Diego an. Die Anlage ist darauf ausgerichtet, Entwickler von Medikamenten in der späten Phase zu unterstützen und der steigenden Nachfrage nach mRNA-basierter Medizin gerecht zu werden. Mit modernster Ausrüstung und erhöhter Produktionskapazität zielt die Anlage darauf ab, das Feld der mRNA-Therapeutika voranzubringen.
Positive
  • TriLink BioTechnologies opens a new cGMP mRNA manufacturing facility in San Diego to support late-phase drug developers.
  • The facility features individual Grade C cleanroom suites, increased mRNA capacity, in-house analytical services, and state-of-the-art equipment.
  • TriLink has over 25 years of industry experience and has supported over 350 programs in biopharma development pipelines.
  • The facility's opening is expected to contribute to the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.
  • TriLink's CleanCap mRNA capping technology has been used in the majority of approved COVID-19 mRNA and saRNA vaccines.
Negative
  • None.

cGMP Facility Streamlines Clinical & Commercial mRNA Drug Substance Development;

Built by mRNA & Industry Experts to Meet Demand for mRNA-based Medicine

SAN DIEGO--(BUSINESS WIRE)-- TriLink BioTechnologies (TriLink®), a Maravai LifeSciences company (NASDAQ: MRVI) and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility. The 32,000-square-foot facility was specifically designed for mRNA manufacturing to support late-phase drug developers from Phase 2 to commercialization via TriLink’s robust mRNA manufacturing capabilities. The milestone opening is expected to help advance the field of mRNA-based medicine as developers flock to leverage the promising modality for a growing list of indications.

TriLink BioTechnologies® Cuts Ribbon on New San Diego Facility for Late Phase mRNA Drug Substance Production (Photo: TriLink BioTechnologies®)

TriLink BioTechnologies® Cuts Ribbon on New San Diego Facility for Late Phase mRNA Drug Substance Production (Photo: TriLink BioTechnologies®)

Located in the Sorrento Valley area of San Diego, the facility features individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity (1g to >100g per batch), comprehensive in-house analytical services, and laboratory space for on-site quality control testing. The manufacturing suites are outfitted with state-of-the-art equipment and ready to onboard clients with late-phase manufacturing needs.

“This facility is expected to help move the needle for life-saving breakthroughs in mRNA-therapeutics,” explained Kevin Lynch, Vice President & General Manager of TriLink’s GMP Operations. “The high-quality manufacture of mRNA drug substances is critical to ensuring the safety and efficacy of this new class of medicines for patients.”

Company and site leadership and industry guests gathered on April 17 to celebrate the facility’s grand opening with a ribbon cutting, expert-led panel discussion, and site tours – all centered around a core theme: Building the Future of mRNA. The thought-provoking panel included insights on the mRNA regulatory landscape, manufacturing evolution, and next-generation tools.

TriLink has reliably delivered GMP services to drug developers since the debut of its first cGMP facility in 2015. Since then, the company’s dedicated team of scientists has provided over 1,000 clients with custom mRNA synthesis, supported 350+ programs in biopharma development pipelines, and delivered over 100 GMP mRNA manufacturing batches.

“TriLink’s depth of industry experience – which spans over 25 years – coupled with its capabilities makes for an unmatched partner,” shared Drew Burch, President of Nucleic Acid Production. “This new facility codifies our commitment to advancing the field by playing a key role in the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.”

In addition to CDMO services and unique mRNA, oligonucleotide, NTP, and plasmid production capabilities, TriLink has developed the award-winning CleanCap® mRNA capping technology used in the majority of approved COVID-19 mRNA and saRNA vaccines, adding momentum to the rapidly growing field.

To learn more about TriLink’s products and services, visit trilinkbiotech.com.

About TriLink BioTechnologies

TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors, and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.

For more information, visit trilinkbiotech.com.

About Maravai LifeSciences

Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world's leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.

For more information about Maravai LifeSciences, visit www.maravai.com.

Forward-looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements constitute forward-looking statements, including, without limitation, statements related to the expectation that the facility will help advance the field of mRNA-based medicine and will help move the needle for life-saving breakthroughs, constitute forward-looking statements identified by words like “expect,” “estimate,” “may,” “soon,” “nears,” “slated,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, operational risks and competition. These and other risks and uncertainties are described in greater detail in the “Risk Factors” section of our most recent Annual Report on Form 10-K, as well as other reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements, and therefore you should not rely upon them. These forward-looking statements reflect our current views and we do not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.

Investor Contact: Deb Hart

Maravai LifeSciences

+ 1 858-988-5917

ir@maravai.com

Media Contact:

Liz Robinson of CG Life

TriLink BioTechnologies

+1 312-997-2436

lrobinson@cglife.com

Source: TriLink BioTechnologies

FAQ

What company announced the opening of a new cGMP mRNA manufacturing facility in San Diego?

TriLink BioTechnologies, a Maravai LifeSciences company (NASDAQ: MRVI), announced the opening of the facility.

What is the purpose of the new facility in San Diego?

The facility is designed to support late-phase drug developers and meet the increasing demand for mRNA-based medicine.

What features does the new facility in San Diego offer?

The facility features individual Grade C cleanroom suites, increased mRNA capacity, in-house analytical services, and state-of-the-art equipment.

How many programs has TriLink supported in biopharma development pipelines?

TriLink has supported over 350 programs in biopharma development pipelines.

What technology developed by TriLink has been used in approved COVID-19 vaccines?

TriLink's CleanCap mRNA capping technology has been used in the majority of approved COVID-19 mRNA and saRNA vaccines.

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Pharmaceutical Preparation Manufacturing
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About MRVI

maravai lifesciences catalyzes the growth of successful, entrepreneurial life science companies by providing expertise, capital, processes and systems so that they can continue to serve scientists who are striving to improve human health. current maravai lifesciences portfolio companies provide enabling tools and services in the life sciences research and bioproduction industries that accelerate breakthrough discoveries in areas such as genomics, proteomics, and biotherapeutic development. maravai lifesciences was formed in march 2014 through a partnership with gtcr, a leading private equity firm. our mission is to build a transformative life sciences reagents company by acquiring outstanding businesses and accelerating their growth. since our founding, we have acquired four companies, each a leader in its market segment. vector laboratories has led the market for labeling and detection products used by researchers in immunohistochemistry, immunofluorescence and related techniques. tri