The latest from CDMOs, CMOs, and suppliers featuring Samsung Biologics, Fujifilm Diosynth Biotechnologies, Vetter, Pii, and Evotec.  

Biologics Manufacturing 
* Samsung Biologics Signs $668-M Contract Mfg Deal
* Fujifilm Diosynth Biotechnologies Completes Cell-Therapy Mfg Expansion 
Formulation Development/Drug Product Manufacturing 
* Vetter Names Three Managing Directors
* Pii Investing $3.6 M To Expand Prefilled Syringe Capabilities 
General 
* Evotec Receives Non-Binding Takeover Bid from Halozyme

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Biologics Manufacturing 

Samsung Biologics Signs $668-M Contract Mfg Deal 
Samsung Biologics, a CDMO of biologics, reports that it has signed a manufacturing services agreement with an undisclosed European pharmaceutical company for $668 million. The deals, worth over $668 million combined, will run through December 2031. The latest agreements bring the company’s cumulative contract value for this year (2024) to more than $4 billion. 

The company also provided an update on several manufacturing expansions. The company is set to add antibody-drug conjugate (ADC) services to its portfolio, with a dedicated facility to be completed by the end of this year (2024), which will allow it to provide a range of services, including ADC process development and conjugation. The company also plans to open its second biocampus in South Korea. next year (2025). A fifth biomanufacturing plant overall and its first in its Biocampus II is on track to be operational in April 2025. Bio Campus II will entail future Plants 5-8 and an open innovation center. 

Source: Samsung Biologics 

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Fujifilm Diosynth Biotechnologies Completes Cell-Therapy Mfg Expansion 
Fujifilm Diosynth Biotechnologies, a CDMO of biologics and advanced therapies, has completed an expansion of its cell-therapy manufacturing facility in Thousand Oaks, California. The  expansion upgrades the development labs and adds two new cell-therapy production suites, which can accommodate open or closed processing and are large enough to support multiple patients’ lots for autologous programs or larger volume batches for allogeneic programs at clinical and commercial scale 

The company’s site in California has the flexibility to produce both clinical and commercial cell therapies, including  allogeneic T cell and CAR T immunotherapies. 

The expansion was announced in December 2023 as part of the company’s overall $200-million investment package in cell-therapy development and manufacturing. The investment package funded expansion of the company’s California site, and Fujfilm Cellular Dynamics’ new headquarters in Madison, Wisconsin. Fujifilm Cellular Dynamics’ new headquarters with cell-therapy manufacturing will be operational in 2026. 

Source: Fujifilm Diosynth Biotechnologies 

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Formulation Development and Drug Product Manufacturing 

Vetter Names Three Managing Directors 
Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, has announced the appointment of three senior leaders to take on the role of Managing Directors, effective January 1, 2025. 

Henryk Badack will lead the company’s quality and development service departments. In his prior role, he served as Senior Vice President, Technical Services and Internal Project Management, where he was responsible for all internal, technical, and infrastructure projects as well as the plant and site development, environmental health and safety, and Vetter Optimization Systems. He also previously led the company’s global sustainability initiatives.

Titus Ottinger will continue to lead finance and controlling, moving from Senior Vice President, Finance & Controlling to Managing Director. He has been responsible for the company’s finances and external accounting. Risk management, insurance, and information for controlling business processes are under his guidance. He originally joined Vetter in 2004.  

Carsten Press joins the Managing Directors’ team with responsibility for the company’s supply chain management and human resources departments. Previously, he served as Senior Vice President, Global Sales Organization & Supply Chain Management, where he oversaw the global sales and supply chain organization along with product management and marketing. He has been with the company since 2009.  

Current Managing Directors, Thomas Otto and Peter Soelkner, will both continue their leadership roles within the company. Thomas Otto will continue to lead the production/engineering and technical service/internal project management departments. He has served as a Managing Director since 2002. Peter Soelkner, serving as a Managing Director since 2008, will continue his role with a focus on corporate development and global sales.  

Source: Vetter 

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Pii Investing $3.6 M To Expand Prefilled Syringe Capabilities 
Pharmaceutics International, Inc. (Pii), a CDMO of drug products, is investing $3.6 million to expand its prefilled syringe capabilities for automating advanced labeling, fill–finish, and automated visual inspection technologies. An Optima syringe labeler, currently being installed, will be fully operational for client use by the late first half / early second half of 2025. This equipment automates syringe labeling, plunger insertion, and safety-device integration.  

Source: Pii 

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General 

Evotec Receives Non-Binding Takeover Bid from Halozyme 
Evotec, a Hamburg, Germany-based CDMO of small-molecule active pharmaceutical ingredients, biologics, and drug products, reported on November 14, 2024, that it had received, without prior contact, a non-binding expression of interest from Halozyme Therapeutics, a San Diego, California-based bio/pharmaceutical and provider of drug-delivery products and services, regarding a takeover offer of EUR 11.00 ($11.52) per share. In a press statement on November 14, 2024, the company said “it will carefully analyze this expression of interest, decide on next steps, and inform the capital market in accordance with the legal requirements.” Halozyme also confirmed the reports.  

Halozyme’s offerings include its Enhanze drug-delivery technology with its proprietary enzyme,  rHuPH20, used to facilitate the subcutaneous delivery of injectable drugs and fluids. The company also develops, manufactures, and commercializes, for itself or with partners, drug-device combination products using its auto-injector technologies. In addition to its headquarters in San Diego, the company has offices in Ewing, New Jersey, and Minnetonka, Minnesota, which is also the site of its operations facility. 

Source: Evotec, Halozyme (November 18, 2024, statement) and Halozyme (November 14, 2024, statement).