Contract Development And Manufacturing Organizations (CDMO)

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Lonza Launches Innovaform Accelerator

Lonza inaugurated its new facility at the Colmar, France site. The new Innovaform Accelerator will serve as a Center of Excellence for developing and innovating capsule-based manufacturing and delivery solutions for oral and pulmonary administration.

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Insights into Biologics and Pharmaceutical Manufacturing

Bill Humphries, CEO of Alcami, shares his vision for the future, discussing dynamic market trends and the company’s commitment to innovation. Under his leadership, Alcami is poised to redefine the pharmaceutical and biotechnology landscape, focusing on cutting-edge solutions and navigating global complexities. This conversation highlights Alcami’s strategic direction, accomplishments, and upcoming challenges.

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The Evolution of the CDMO Industry

The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine. CHEManager asked executives and industry experts from a broad range of CDMOs to share their views on how their companies are dealing with this changing economic environment and the resulting opportunities and challenges.

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The CDMO/CMO Report

Driven by increased demand in biologic-based drugs, biologic drug substance manufacturing continues to be an active area of investment by contract development and manufacturing organizations/contract manufacturing organizations (CDMOs/CMOs), including several multi-billion large-scale biomanufacturing projects. What companies are expanding, and where do these expansions stand?

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Serán More Than Doubles Clinical Manufacturing Capacity

CDMO Serán BioScience recently announced that it has completed an expansion to increase the number of process manufacturing suites at its facility in Bend, Oregon, from 6 to 14, adding approximately 130% more cGMP clinical manufacturing capacity.

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Olon Acquires Huvepharma Italia

Olon continues its growth path and increases its total production capacity following the acquisition of Huvepharma Italia and its site in Garessio, Cuneo, in the northwestern part of Italy.

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Bora Completes Buy of Emergent’s US Sterile Fill/Finish Site

Bora Pharmaceuticals, a Taiwan-headquartered contract development and manufacturing organization (CDMO), has completed the acquisition of Emergent BioSolutions' sterile manufacturing facility in Baltimore-Camden, Maryland, USA. The facility adds drug product fill/finish to Bora’s extensive biologics drug substance capabilities.

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The Shifting CDMO Leadership Landscape

A recent report by consulting company WittKiefer delves into the role of CDMOs within the pharmaceutical industry, evaluating the effectiveness of existing leadership structures and expertise in navigating market complexities.

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Touchlight and GSK Sign License Agreement for DNA Production

Touchlight, a UK-based custom development and manufacturing organization (CDMO) specializing in enzymatic DNA production, signed a license agreement with British drugmaker GSK which grants GSK non-exclusive rights to use Touchlight’s proprietary enzymatic dbDNA (doggybone DNA) technology for the development and production of mRNA-based products.

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Agilent to Buy Canadian CDMO Biovectra for $925 Million

Santa Clara, CA-based Agilent Technologies has signed a definitive agreement to acquire specialized contract development and manufacturing organization Biovectra from H.I.G. Capital in a move to expand its end-to-end biopharma solutions.

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Navin Molecular Plans €32.6 Million Expansion of GMP Manufacturing

Navin Molecular, an Indian-headquartered CDMO with small molecule development and manufacturing capabilities, recently announced a Rs 288 Crore (approximately €32.6 million/$35 million) investment to construct a 9,000 m2 GMP manufacturing plant in Dewas, India. The new facility will nearly double the overall capacity at the site to 420 m3. It will support existing commercial-scale projects and meet future demands as the company continues to expand its global customer base.

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SK Bioscience Acquires Majority Stake in IDT Biologika

South Korea-headquartered contract development and manufacturing organization (CDMO) SK Bioscience plans to acquire a 60% stake in IDT Biologika, a German CDMO specialized in vaccines, gene and immune therapy and oncolytic viruses, from Klocke Group. Klocke will retain a 40% stake in IDT Biologika and thus remains the company's second-largest shareholder.

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Veranova Expands ADC and HPAPI Capabilities in the US

US contract development and manufacturing organization (CDMO) Veranova has initiated an expansion of its antibody-drug conjugate (ADC) and highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing capabilities at its US facility in Devens, Massachusetts.

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Siegfried to Buy Early-Phase CDMO Site from Curia

Zofingen, Switzerland-based contract development and manufacturing organization (CDMO) Siegfried has signed a binding agreement to acquire an early-phase CDMO site in Grafton, Wisconsin, US, from Curia. The transaction is expected to close by July 1, subject to customary closing conditions.

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Siegfried to Acquire Early-Phase CDMO in US

Siegfried, a global Contract Development and Manufacturing Organization (CDMO) for the pharmaceutical industry headquartered in Zofingen, Switzerland, has signed binding agreements with Curia Global for the acquisition of an early-phase CDMO site in Grafton, Wisconsin, US.

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Aurigene Opens Biologics Facility

Aurigene Pharmaceutical Services Limited (Aurigene), a Dr. Reddy’s Laboratories Limited company, inaugurated its biologics facility spread across 6500 m2 (70,000 sq ft) in Hyderabad, India.

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Sterling Expands HPAPI Capabilities at US Facility

UK-headquartered contract development and manufacturing organization (CDMO) Sterling Pharma Solutions has invested $3 million at its US facility in Germantown, WI, to expand the company’s integrated antibody-drug conjugate (ADC) development and manufacturing capabilities.

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Kühne Holding Acquires Aenova from BC Partners

Kühne Holding has agreed to purchase Aenova Group, a pharma contract development and manufacturing organization (CDMO), from BC Partners. BC will reinvest and retain a minority stake in Aenova. The financial terms remain undisclosed.

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Fujifilm Invests Additional $1.2 Billion in CDMO Business in North Carolina

Fujifilm announced an additional investment of $1.2 billion in its large-scale cell culture contract development and manufacturing organization (CDMO) business to further expand the planned Fujifilm Diosynth Biotechnologies facility in Holly Springs, North Carolina, bringing the total investment in the facility to over $3.2 billion. Plans for the new site were unveiled in September last year.

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A New Standard of Collaboration for the Pharmaceutical Industry

Headquartered in Cramlington, UK, Sterling Pharma Solutions is a contract development and manufacturing organization (CDMO) that provides a range of services to the global biopharmaceutical industry, including active pharmaceutical ingredient (API) development, scale-up and cGMP manufacturing, as well as antibody drug conjugate (ADC) R&D and clinical-scale GMP manufacturing.

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Antheia and Olon Continue Biomanufacturing Partnership

US biotech company Antheia and Olon, an Italian producer of active pharmaceutical ingredients (APIs), have announced the continuation of their ongoing partnership to utilize Olon’s fermentation infrastructure for the scale-up and commercialization of Antheia’s early products.

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Novo Holdings to Acquire Catalent for $16.5 Billion

Novo Holdings, Novo Nordisk's parent company, is acquiring US contract development and manufacturing organization (CDMO) Catalent for $16.5 billion. The companies said that Novo Holdings will acquire all outstanding shares of Catalent for $63.50 per share in cash.

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Siegfried Announces Changes in Senior Management Team

Siegfried has appointed Marianne Späne, currently chief business officer Drug Products, as chief business officer with responsibility for both the Drug Substances and Drug Products divisions of the Swiss contract manufacturing and development organization (CDMO), effective Feb. 1, 2024. Christian Dowdeswell, who previously led the Drug Substance business, has decided to leave Siegfried.

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Lonza and Oxford Nanopore to Collaborate on mRNA Analysis

Swiss contract development and manufacturing organization (CDMO) Lonza will collaborate with Oxford Nanopore Technologies, a UK-based company delivering a new generation of nanopore-based molecular sensing technology. The collaboration aims to cGMP validate and commercialize a first-of-its-kind novel test to accurately determine multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the messenger RNA (mRNA).

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Biosynth Acquires VIO Chemicals

Swiss Biosynth, a supplier of raw materials to the life science industry, has acquired VIO Chemicals, a Zurich, Switzerland-based company with leading chemical R&D expertise and a global network of large-scale manufacturing partners. Financial details of the transaction have not been disclosed.

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