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DCAT Week: Highlights from the Member Company Announcement Forum

Samsung Biologics, Fujifilm Diosynth Biotechnologies, WuXi STA and more shared major news—including investments, expansions & acquisitions.

Kicking off DCAT Week on March 18, DCAT Member Companies shared major news announcements—from investments and acquisitions to expansions and more—at the much-anticipated DCAT Member Company Announcement Forum. Senior executives from across the bio/pharmaceutical manufacturing value chain gave short presentations highlighting recent major developments. Below, see some of the highlights from the forum:

Samsung Biologics

Kevin Sharp, senior vice president, head of global sales, Samsung Biologics, discussed how the company plans to continue making strategic investments in expanding capacity and global reach, while enhancing capabilities to better meet clients’ evolving needs. Having commenced full operation at Plant 4 and completing its Bio Campus I in 2023, Samsung Biologics is now beginning construction of Bio Campus II. Plant 5, the first facility of the company’s second Bio Campus will include 4 plants in total and represents a $1.46 billion investment. It is set to begin operations in April 2025. In total, Bio Campus II will be 30% larger than Bio Campus I and represents a $6 billion investment for the company. Also, in an effort to diversify its business portfolio, the company’s separate antibody-drug conjugate (ADC) manufacturing facility is set to be cGMP-ready within 2024, enabling the exploration of innovative technologies for next-generation biomedicines. This aligns with investments the company has made through the Samsung Life Science Fund, supporting biotechs like AimedBio and Araris Biotech AG in ADC technology.

Noramco

Bill Grubb, vice president, corporate development Noramco, highlighted the company’s recent acquisition of Halo Pharma. Noramco is focused on the production of controlled substances for the pharmaceutical industry, for medicines used to treat Attention Deficit Hyperactivity Disorder, pain, addiction, and for abuse-deterrent formulations. With operations in Whippany, NJ, and Montreal, Quebec, Halo Pharma is a contract development and manufacturing organization (CDMO) that provides a wide range of manufacturing services for diverse dosage forms, catering to both brand and generic pharmaceutical clients from development through commercialization. Bringing Halo into the Noramco family is anticipated to provide API customers of Noramco, and its cannabidiol-focused subsidiary Purisys, additional capabilities in drug product formulation development, clinical and commercial drug product manufacturing, and packaging.

Simtra BioPharma Solutions

Simtra BioPharma Solutions, formerly Baxter International Inc.’s BioPharma Solutions Business, became a standalone CDMO in 2023. Franco Negron, CEO of Simtra, highlighted the company’s $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, Indiana. A new, state of the art 150,000 square foot building will be constructed to house two high-speed automated isolator syringe fill lines and a new high speed isolator vial line equipped with three 30 square meter lyophilizers. Each process suite in the new building will be fitted with dedicated formulation/compounding rooms. The expansion will also include the addition of a dedicated clinical line equipped to support Simtra’s growing development/clinical business. This line will utilize existing facility infrastructure. The clinical line is expected to be ready to onboard new projects by summer 2025. Construction of the new building is planned to begin in June 2024 and anticipated to take two years to complete, allowing for GMP readiness in late 2026.

Fujifilm Diosynth Biotechnologies

Lars Petersen, president and CEO, highlighted Fujifilm Diosynth Biotechnologies’ application of the KojoX operational framework, which aims to scale faster, reduce regulatory burden and create unprecedented supply chain agility. The framework’s key tenets are efficiency and flexibility in design. Investments executed under the KojoX framework include a $1.6 billion investment in a large scale cell culture capacity expansion at the company’s Denmark facility; a $2 billion investment in a large scale cell culture capacity expansion at the Holly Springs, North Carolina facility; and a cell therapy expansion at the Thousand Oaks, CA facility.

WuXi STA

According to Yu Lu, chief business officer at WuXi STA, and also head of WuXi TIDES and WuXi AppTec, WuXi STA supported 27% of small molecule drugs approved by the FDA in 2023. And, despite the looming threat of sanctions on WuXi AppTec and WuXi Biologics proposed by Congress, the company shows no signs of slowing down. Yu Lu highlighted expansions in the company’s small molecule, oglionucleotide and peptide capabilities around the world. Most recently, WuXi STA commissioned two new peptide manufacturing plants, one at its Changzhou facility and another at the new Taixing site in China. Commissioning the peptide plant at the Taixing site marks its official launch as the newest and largest of WuXi AppTec’s five API production sites. Spanning a total area of 169 acres, the Taixing site is designed to manufacture a range of synthetic molecules, including small molecules, peptides, oligonucleotides, and conjugates. The phase I construction includes nine plants with the total reactor volume exceeding 1,000 m3, including a dedicated plant for API clean rooms. Once Taixing site Phase I is fully operational in 2025, the company’s total reactor volume for small molecule API and intermediate manufacturing will surpass 4,000 m3. Also, last year, WuXi STA launched its first high potency (HP), fully automated sterile injectable manufacturing line at the drug product site in Wuxi City, China. The new HP injectable manufacturing line, with an annual capacity of 12 million units, further enhances the company’s manufacturing capabilities and capacity for injectable dosage forms.

Kindeva Drug Delivery

Kindeva CEO Milton Boyer presented the CDMO’s latest capital expansions and acquisitions in drug-device combination products. In April 2023, Kindeva announced plans to expand manufacturing capabilities in Bridgeton, MO — investing more than $100 million over four years in a newly purchased facility. Meridian, which recently combined with Kindeva, will be converting this new 155,000-square-foot facility to support increased production of drug-device combination products, sterile fill-finish capabilities, and create job opportunities in the St. Louis area. In December, Kindeva entered a co-development collaboration with Orbia Fluorinated Solutions (Koura) for the conversion from existing marketed pressurized Metered Dose Inhaler (pMDI) products to Koura’s more sustainable and environmentally-conscious medical propellant; HFA 152a, known as Zephex 152a. Most recently, in January 2024, Kindeva acquired Summit Biosciences Inc., an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders. Established in 2009, Summit has a track record of innovation in the unit dose nasal spray market. The acquisition of Summit enhances Kindeva’s existing drug-delivery capabilities by adding a new drug-delivery platform, further expanding Kindeva’s ability to serve biopharma customers across a wider range of complex drug-device combination products (pulmonary, injectable, transdermal, and nasal).

Seqens

Pierre Luzeau, CEO of Seqens, highlighted the company’s recent acquisition of Novartis’s cell therapy business, CellforCure. With this purchase, the France-based CDMO adds cell and gene therapy manufacturing to its pharmaceutical services.

Adragos Pharma

In just 3.5 years, Adragos, a founder-led CDMO with headquarters in Munich, Germany, has established an extensive and expanding network. According to Cem Goekmen, head of corporate development, its declared goal is to expand its existing production network through acquisitions in Europe, North America, and Japan to attain a globally leading position within the next few years and set new standards in customer service and data centricity. In its buy-and-build growth strategy, Adragos Pharma is supported by FSN Capital, a Scandinavian investment firm, and the Prange Group, a diversified German family business. Adragos Pharma currently operates three production sites in France, Germany, and Japan, and a development center in Greece.

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