Catalent Acquires Accorda’s Drug-Product, Pkg Ops; Lonza, Regis Expand

The latest from CDMOs, CMOs, and suppliers featuring Catalent, Lonza, Thermo Fisher, Fujifilm, Regis, Cascade Chemistry, Wavelength Pharmaceuticals, and others.

Chemicals/Chemical API Manufacturing

Regis Expands Facilities for API Development, Mfg
Regis Technologies, a Morton Grove, Illinois-based CDMO of small-molecule active pharmaceutical ingredients (APIs), has completed an expansion of its laboratory facilities in Morton Grove.

The new 9,000-square-foot expansion includes additional process chemistry and analytical laboratories, a dedicated ICP-MS suite, additional climate-controlled storage, 14 additional fume hoods, several new kilo-scale reactors, and process safety equipment for reaction calorimetry measurements In addition, the new laboratories have an advanced variable air volume air system for clean energy-efficient operations.

Source: Regis Technologies

Wavelength Pharmaceuticals Acquires Majority Stake in Vanamali Organics
Wavelength Pharmaceuticals, a Petah Tikvah, Israel-based CDMO of active pharmaceutical ingredients (APIs), has acquired a majority stake in Vanamali Organics, a Telangana, India-based manufacturer of pharmaceutical starting materials and drug intermediates.

The acquisition strengthens Wavelength’s drug-substance manufacturing footprint, global supply chain, and API CDMO business. Vanamali Organics provides customized process development and manufacturing services.

Source: Wavelength Pharmaceuticals

Cascade Chemistry Investing $14 M To Expand API Mfg Capacity
Cascade Chemistry, a Eugene, Oregon-based CDMO, has initiated construction of new facilities to expand its manufacturing capacity for active pharmaceutical ingredients (APIs) through a $14-million investment.

The new facilities, expected to be operational in the first quarter of 2022, will increase the company’s floor space three-fold and add to its manufacturing capacity and scale. The expansion also includes 2,200 square feet of new analytical labs, a quality system, and additional office space.

The 28,000-square-foot building, currently under construction, will initially include five suites for Phase I and Phase II manufacturing with flow hydrogenation and reactors up to 400 liters. Additional capacity for API Phase III and commercial-scale manufacturing up to 1,000 liters will be added in 2022. The second building, with 7,000 square feet, is reserved for future expansion.

Source: Cascade Chemistry

Biologics Manufacturing

Thermo Fisher Acquires Cell Sorting Technology from Propel Labs
Thermo Fisher Scientific has acquired cell sorting technology assets from Propel Labs, a wholly owned subsidiary of SIDIS Corp., a Fort Collins, Colorado-based investment and management company.  

Under the agreement, the recently introduced Bigfoot Spectral Cell Sorter and approximately 40 employees will become part of Thermo Fisher’s Biosciences business. Propel Labs will continue to operate as a separate entity.

Source: Thermo Fisher Scientific

Formulation Development/Drug-Product Manufacturing

Catalent Completes Acquisition of Acorda’s Drug Product Mfg, Packaging Ops
Catalent has completed its acquisition of the manufacturing and packaging operations of Acorda Therapeutics, an Ardsley, New York-based pharmaceutical company.

Catalent acquired Acorda Therapeutics’ 90,000-square-foot, facility in Chelsea, Massachusetts. The site operates spray-drying capacity and will provide Catalent with commercial-scale capacity. The facility will act as a global center of excellence within the Catalent network for spray-dried dispersion and dry-powder encapsulation and packaging. Acorda Therapeutics’ current workforce at the facility will transition employment to Catalent.

Catalent has entered into a long-term supply agreement with Acorda to continue commercial manufacture of Inbrija (levodopa inhalation powder), drug for treating Parkinson’s disease, from the Chelsea facility.

The Chelsea site will complement and provide downstream capabilities to Catalent’s 180,000- square-foot inhalation development facility in Morrisville, Research Triangle Park, North Carolina, which provides development and manufacturing for metered-dose inhalers, nasal sprays, and dry-powder inhalers. The Morrisville site offers high-speed commercial-scale manufacturing as well as flexible fill lines for clinical-scale and small batch production.

Catalent paid Acorda $80 million at closing, resulting in expected net proceeds to Acorda of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments.

Source: Catalent and Acorda Therapeutics

Lonza Expands Solid Form Services
Lonza has announced an expansion of its solid form selection services based at its site in Bend, Oregon site.

The increased services and team complement previously established SimpliFiH Solutions services consisting of phase-appropriate drug-substance and drug-product development and manufacture. Lonza’s solid form services include form and salt/cocrystal screening, solid state characterization, chemical composition, solubility and dissolution, and powder properties.

Source: Lonza


PwC To Partner in CPI’s Medicines Mfg Center
The Center for Process Innovation (CPI) has signed of an agreement with the accounting and management consulting firm, PwC, to make it a partner in the Medicines Manufacturing Innovation Center collaboration in Renfrewshire, Scotland.

The center is a collaboration between CPI, the University of Strathclyde in Glasgow, Scotland, and founding industry partners, GlaxoSmithKline and AstraZeneca. The program is part-funded by Innovate UK, the UK government’s innovation agency, through the Industrial Strategy Challenge Fund and Scottish Enterprise, a government economic development organization, via the Scottish Government.

PwC will contribute to the consortium by increasing opportunities for business development, evaluate the marketplace for future technologies, act as a scout for new disruptive innovations, organizations, and global opportunities, and develop market analysis and studies.

Construction on the Medicines Manufacturing Innovation Center was announced in October 2020. The center will focus on innovative approaches in small-molecule drug and drug-product manufacturing. It will be available to companies to evaluate, test, and prototype processes, including continuous, digital, and autonomous manufacturing. The facility is slated for completion in late 2021 and will be operational in early 2022. It is expected to eventually house over 80 staff in both technical and non-technical roles.

Source: Center for Process Innovation

Fujifilm To Acquire Hitachi’s Diagnostic Imaging Business
Fujifilm has agreed to acquire Hitachi’s diagnostic imaging-related business as part of a plan to further expand its healthcare business.

Hitachi and Fujifilm have signed an agreement for an absorption-type company split. Under the acquisition, Hitachi and its consolidated subsidiaries and affiliate companies will be transferred to a newly established company, Fujifilm Healthcare, and transfer all shares of Fujifilm Healthcare to Fujifilm after the company split. The acquisition process is expected to be completed on March 31, 2021.

Through this acquisition, Fujifilm will further expand its Medical Systems business. The Diagnostic imaging-related business provides a suite of products including CT, MRI, X-ray, and ultrasound systems.

Source: Fujifilm and Hitachi

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