Newsletter | April 3, 2024

04.03.24 -- Streamline Your Outsourcing Journey & Discover Top CDMOs

Considering outsourcing the development and manufacturing of your innovative therapeutic? The Outsourced Pharma Capacity Update (OPCU) can help. This event gathers experts from industry-leading CDMOs to present their current capacity and available services.

 

Within this newsletter, you'll find presenting sponsors and recordings from our February 2024 event. Gain valuable insights into the capabilities of industry suppliers through these concise and informative presentations, all without leaving your desk.

 

Don't miss the chance to discover viable options for your development and manufacturing needs. Join top CDMOs at the upcoming OPCU in May 2024. Secure your spot at this virtual event! Registration is free at the links below.

 

LARGE MOLECULE

KBI Biopharma

Learn how KBI Biopharma is equipped to support drug development and biologics manufacturing and accelerate your timeline. GMP drug substance manufacturing is available in our FDA and PMDA licensed facility at 300L and 2,000L scale, with full release and stability services on site.

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KBI Biopharma

Mabion

Explore Mabion's new installations in upstream development, new bioreactors, as well as downstream development and fill/finish. This state of the art EU-GMP certified facility is staffed by a team of 250 professionals and, as of 2023, is focused solely on providing CDMO services to its clients.

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Mabion

Resilience US, Inc.

With a strong network of sites across six states and one in Canada, Resilience provides innovative solutions and services for established and emerging therapies. Hear Evan Pasenello, Business Head of Biologics & Vaccines, discuss how Resilience can support your development and manufacturing programs.

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Resilience US, Inc.

Singota Solutions

Singota Solutions is focused on meeting the needs of small/early stage biotech companies and getting products to patients faster by being agile, accountable, and transparent. Discover Singota’s capabilities in providing formulation development, analytical development, aseptic manufacturing, and supply chain services.

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Singota Solutions

Novartis Contract Manufacturing

Review the mammalian development services, manufacturing solutions, and Novartis manufacturing sites accessible to external clients. As we expand our mammalian capacity across the manufacturing network, updates on completion dates and capacity availability are presented in the session.

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Novartis Contract Manufacturing

Abzena

Moving a new biologic or bioconjugate program forward from discovery to market can be a challenging and cumbersome process. Hear expert insight from Abzena’s CTO on how to de-risk and streamline the development of your biopharmaceutical in order to successfully meet your next regulatory or clinical milestone.

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Abzena

Simtra BioPharma Solutions

Simtra is a premier CMO with a singular focus on sterile injectable drug product form/fill/finish services. Simtra currently has open capacity for liquid vial projects at both manufacturing sites and can support rapid tech transfer depending on the complexity of the project and the availability of raw materials.

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Simtra BioPharma Solutions

FUJIFILM Diosynth Biotechnologies

Jacob Øgaard presents an update on FDB’s currently available and incoming large scale capacity and capabilities for the drug substance manufacturing of biologics across the CDMO’s global locations in the United States and Europe, with emphasis on their HillerØd, Denmark, and Holly Springs, NC, USA sites.

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FUJIFILM Diosynth Biotechnologies

EirGenix Inc.

EirGenix is Taiwan's largest CDMO for mammalian and microbial-derived, clinical, and commercial manufacturing of biologics. We have immediate availability of capacity up to 12 x 2,000 L SUBs for mammalian cells and up to 150 L scale for microbial, and that will increase to 350L and 1,000L by end of this year.

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EirGenix Inc.

SMALL MOLECULE

Societal CDMO

Societal is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, packaging, and logistics services. Senior Vice President and Chief Scientific Officer, Richard Sidwell, Ph.D., delves into Societal’s capabilities and open capacity across sites.

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Societal™ CDMO

Ajinomoto Bio-Pharma Services

Our experts delve into the advancements in our development and manufacturing capabilities for HPAPI, clinical development, and late-stage projects. Discover how recent expansions of Ajinomoto Bio-Pharma Services, including new labs, flow units, and expanded capacity, can help you to fulfill all your small molecule needs.

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Ajinomoto Bio-Pharma Services

Cambrex

Cambrex offers strong expertise in custom development and cGMP API manufacturing for small molecules, including HPAPI, through its Charles City, Iowa facility. Cambrex provides comprehensive analytical and IND-enabling services, as well as drug substance development and manufacturing across the entire drug lifecycle.

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Cambrex

Nanoform

Explore Nanoform's CESS technology for nanoparticle generation and the types of particles that can be generated without the need for solvents or excipients. Case studies show how nanoparticles can enable faster onset of oral medications, extend the therapeutic window of long-acting implants, and increase drug loading.

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Nanoform

CELL & GENE

FUJIFILM Diosynth Biotechnologies

Following FUJIFILM's recent investment in cell therapy services, this presentation offers a glimpse into the flexible, smart designs included in the capacity expansion at the Thousand Oaks facility. Review examples of flexibility and state-of-the art designs to ensure that every cell therapy program can be produced at FDB California.

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FUJIFILM Diosynth Biotechnologies

AGC Biologics

Learn more about the AGC Biologics’ global Cell and Gene network, track record, capabilities, and how it can provide support for any project. This presentation also provides a detailed look at the North American site in Longmont, Colorado, which specializes in both cell and viral vector gene therapy projects.

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AGC Biologics

Aldevron

With over 25 years of service, Aldevron is a premier CDMO, producing high-quality research and GMP-grade pDNA, mRNA, and protein for drug substance and drug product. Examine our ready-for-use products and review our new capacity for cGMP RNP manufacturing to streamline CRISPR gene editing programs.

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Aldevron

BioCentriq

BioCentriq offers state-of-the-art facilities, an established track record in GMP drug product release, and customized solutions supported by a seasoned team. Learn how the innovative LEAP platform is spearheading advancements in CAR-T manufacturing and accelerating clinical development timelines.

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BioCentriq

Novartis Contract Manufacturing

Gain an overview of the cell and gene manufacturing services provided by Novartis Contract Manufacturing and how the in-house capabilities within our network can support clients' needs in end-to-end production. An update on our new viral vector facility and available capacity are discussed.

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Novartis Contract Manufacturing

ElevateBio

Explore our BaseCamp® facility as we share how our unique ecosystem brings together R&D platforms, cGMP manufacturing, and groundbreaking technologies to help enhance speed, delivery, and probability of success to support all stages of cell and gene therapy development and manufacturing.

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ElevateBio

Forge Biologics

Discover Forge’s 200,000 square foot, custom-designed cGMP facility dedicated to AAV and plasmid manufacturing. Forge’s end-to-end development and manufacturing capabilities include research-grade production, analytical and process development, toxicology, engineering, and cGMP manufacturing.

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Forge Biologics

EVENT REGISTRATION

 

Streamline your search for the ideal CDMO partner at the May 2024 OPCU virtual event! Registration is open now, offering you the opportunity to connect with numerous CDMOs in a single day and avoid the hassle of an extended vetting process.

 

For your convenience, OPCU is grouped by molecule type. You can register for the session(s) highlighting the CDMOs equipped to meet your company's development and manufacturing needs.