As part of the DCAT Member Company Announcement Forum, held on March 21, 2022, at DCAT Week, the flagship event of the Drug, Chemical & Associated Technologies Association (DCAT), DCAT invited its Member Companies to submit major news announcements from their companies of significance to the bio/pharmaceutical manufacturing value chain. The news could cover manufacturing expansions, mergers and acquisitions (M&A), including post-M&A integration, or other key corporate developments with the announcements or related news made in the announcement occurring in 2022 and beyond.

CEOs and senior executives from 12 DCAT Member Companies were selected to outline their news at the DCAT Member Company Announcement Forum on March 21, 2022. Given time limits in the two-hour program, all DCAT Member Companies were given the opportunity to share news as part of this special edition of DCAT Value Chain Insights that highlights news from DCAT Week. The news submitted below are from companies involved in formulation development, drug-product manufacturing, and packaging.

• Adare Pharma Completes Acquisition of Frontida BioPharm
• ACG To Open Large-Scale Capsules Mfg Facility
• BSP Progresses Expansion Plan
• Bushu Pharma Progresses Asian Supply Chain Hub
• Delpharm Integrates Two Facility Acquisitions
• DFE Pharma Opens New Center of Excellence
• DFE Pharma, Sterling & Harro Höfliger Launch Inhalation Alliance
• Grand River Aseptic Manufacturing Expands
• Nanoform Expands GMP capacity, Adds High-Potent Handling
• Roquette To Open New Innovation Center
• Stevanato Group Expanding Vial Capacity; Awarded US Gov’t Funding
• Datwyler Completes Acquisition in China

Adare Pharma Completes Acquisition of Frontida BioPharm
Adare Pharma Solutions, a CDMO of drug product and drug-delivery services, completed the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition further enhances Adare’s capabilities in product development through commercial-scale manufacturing and packaging. With the acquisition, the company added new capabilities such as high-potency compound handling and packaging services.

Source: Adare Pharma Solutions

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ACG To Open Large-Scale Capsules Mfg Facility
ACG, a provider of hard-shell capsules, equipment, film and foil barriers, packing, and track-and-trace systems, is slated to open a large-scale capsules-manufacturing plant in Aurangabad, Maharashtra, India, and plans further expansion. Capable of producing 40 billion capsules per year, the plant will include a research and development center and be powered by green, renewable energy and use industry 4.0 technologies.

Source : ACG

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BSP Progresses Expansion Plan
BSP Pharmaceuticals, a Latina, Italy-based CDMO, is progressing a $410-million investment to expand cytotoxic and non-cytotoxic capacity. The investment is focused on the expansion of a newly built segregated facility with of up to seven sterile suites for the manufacturing of non-cytotoxic lyophilized and liquid vials, and the completion of one additional sterile suite for manufacturing cytotoxic compounds, and two new conjugation suites for both drug substances and drug products to sustain growth of clinical and commercial candidates for the antibody drug conjugate and liposomal fields. In January (January 2022), BSP began construction of a new warehouse to increase storage capacity and cold-chain management currently available on site, for oncology and biological compounds, with 7,500 pallet places at room temperature and about 1,000 pallet places for refrigerated and deep-frozen materials, from 2-8°C to – 85°C.

Source: BSP Pharmaceuticals

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Bushu Pharma Progresses Asian Supply Chain Hub
Bushu Pharma a Japanese CDMO specializing in oral solid and injectable dosage forms, packaging, labeling and distribution, is progressing its “Gateway to Asia” platform, which supports both the manufacturing and supply chain of pharmaceuticals throughout Asia by accepting bulk products globally and providing inspection for quality, labeling, customized packaging, and distribution to more than 55 exporting countries.

Source: Bushu Pharma

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Delpharm Integrates Two Facility Acquisitions
Delpharm , a Boulogne-Billancourt, France-based CDMO, expanded its manufacturing network with two additional plants. In early March (March 2022), the completed the acquisition of the Boucherville sterile injectable manufacturing site owned by Sandoz Canada, in Québec. Last October (October 2021), Delpharm acquired the Poznań manufacturing site owned by GlaxoSmithKline in Poland and added high-potent softgel capsules to the company’s portfolio. The plant increases Delpharm’s capacity in solid and semi-solid forms. Overall, the company provides more than 1 billion packs annually.

Source: Delpharm

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DFE Pharma Opens New Center of Excellence
DFE Pharma, an excipient producer based in Goch, Germany, is opening a new center of excellence, called Closer to Formulator (C2F), in Hyderabad , India, this month (April 2022). C2F will support companies globally in the formulation or re-formulation of products by building process efficiencies, improving success with technology transfers, and introducing innovative technologies in development. Through this center, the company will optimize excipient selection and formulation design in line with the FDA’s Quality-by-Design approach for integrating expertise, and therefore quality, into a product from the very start.

Source: DFE Pharma

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DFE Pharma, Sterling & Harro Höfliger Launch Inhalation Alliance
DFE Pharma, an excipient manufacturer, Sterling SpA, a CDMO of active pharmaceutical ingredients (APIs), and Harro Höfliger, a manufacturer of production and packaging equipment, have formed an alliance for respiratory medicine development. The alliance, called INTO, is a combined service offering from the companies.

DFE Pharma provides excipients and support for dry-powder inhalation formulations. It has three dedicated inhalation production sites.

Sterling provides synthesis, process development, solid-state science, material characterization, commercial manufacturing and life-cycle management for APIs, including those for the respiratory sector used in pressurized meter dose inhalers and dry-powder inhalers.

In the inhalation area, Harro Höfliger, provides dosing technology for filling powder into dry-powder inhalers. The processes are designed to manufacture blisters, capsules, disks, cartridges or reservoirs dry-powder inhaler closure systems.

Source: DFE Pharma, Sterling & Harro Höfliger

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Grand River Aseptic Manufacturing Expands
Grand River Aseptic Manufacturing, a CDMO of injectables, has invested in a Bausch+Ströbel VarioSys flexible filling line with SKAN isolator as part of its latest facility expansion. Through its interchangeable design, the VarioSys provides the flexibility to increase production capacity with the option to dedicate complete modules to individual drug products. The new equipment will arrive at the company’s Grand Rapids, Michigan, filling facility in May (May 2022).

Source: Grand River Aseptic Manufacturing

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Nanoform Expands GMP capacity, Adds High-Potent Handling
Nanoform, a provider of nanoparticle technologies and formulation services, is setting up a GMP facility in Helsinki, Finland, to manufacture active pharmaceutical ingredient (API) nanoparticles created by the company’s small-molecule nanoparticle technology, Controlled Expansion of Supercritical Solutions (CESS)

In 2022, the company is tripling its nanoforming GMP API manufacturing capacity and adding GMP analytical development and characterization capability. This expansion program will add two new CESS manufacturing suites in Class-D cleanrooms to triple its CESS nanoforming capacity. It will further establish internal GMP analytical capabilities. These two additional manufacturing suites, together with the GMP analytical characterization laboratories, are geared to handle highly potent compounds (occupational exposure limit < 30 ng/m³) and will increase the company’s capabilities in highly potent small-molecule particle engineering. The expansion is expected to be operational in the fourth quarter of 2022.

Source: Nanoform

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Roquette To Open New Innovation Center
Roquette, an excipient manufacturer, plans to open a new pharmaceutical Innovation Center in Pennsylvania, in early 2023. Measuring 23,000 square feet, the new center will have an Applied Sciences facility and Customer Technical Services laboratory, as well as an auditorium for monthly symposiums and customer training. Many of the advancements that Roquette will be focused on at the new laboratory will be in drug-delivery technologies for increased patient compliance. The center will join sister sites in Singapore and France.

Source: Roquette

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Stevanato Group Expanding Vial Capacity; Awarded US Gov’t Funding
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services,  reports that its subsidiary, OMPI of America Inc., has entered into an agreement to support the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, through its partnership with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, under which BARDA has agreed to provide up to approximately $95 million to Stevanato Group.

Under the agreement, Stevanato Group has agreed to expand its planned manufacturing capacity in Fishers, Indiana, for both standard and EZ-Fill vials. BARDA’s financing is intended to strengthen domestic capabilities in the US for national defense readiness and preparedness programs for current and future public health emergencies. In addition, Stevanato Group has agreed to provide priority access to designated BARDA vaccine and drug development partners, when necessary.

Source: Stevanato Group

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Datwyler Completes Acquisition in China
Datwyler, a supplier of customized sealing products, has completed its acquisition of Chinese Yantai Xinhui Packing, representing the first foothold in China for the company’s healthcare business. Located in Shandong, Xinhui manufacturers elastomer components, such as isoprene rubber discs, which complement Datwyler’s current portfolio of pharmaceutical packaging and medical solutions. Xinhui’s recently refurbished plant will operate at Datwyler’s advanced production level for manufacturing components for small-molecule drugs. With the acquisition, Datwyler now has eight healthcare production facilities across China, India, Italy, Germany, Belgium, and the US to support close to $500 million in sales in more than 100 countries.