Feliza Mirasol is the science editor for 

Feliza Mirasol

On Aug. 1, 2024, Freudenberg Medical announced  an expansion to its biopharma product portfolio, which now includes custom single-use assemblies. The assemblies will be combined with the company’s expertise in silicone extrusion and molding. Included in the new offerings are single-use Y-connector manifolds, tubing assemblies, and bottle cap assemblies with multiple inlets/outlets. Both labs and current good manufacturing practice (CGMP) bioprocesses commonly use bottlecap assemblies with Y-connector tubing for critical fluid transfer applications, according to the company in a press release.

The assemblies are cleanroom manufactured according to customer specifications. Among the advantages, Y-connector overmolds offer unobstructed flow within a critical fluid path and can prevent leaks from occurring. Leaks are commonly seen with standard fluid couplings, fittings, and connectors, according to Freudenberg. “Validated production processes with proven process capabilities will continuously ensure consistent overmolding of Y-manifolds on customer-specified tube ends,” the company stated in the press release.

The expanded biopharma portfolio complements the company’s existing PharmaFocus Premium product line containing high purity, platinum-cured silicone tubing and sanitary ends for single-use systems. The company’s tubing, molded components, and systems are used in bioprocessing, biotechnology, lab processes, GMP manufacturing, small batch processes, and cell and gene therapy as well as for the production of messenger RNA, biosimilars, and regenerative proteins.

The company’s other expansion activities include a $50 million investment in a new Hemoteq AG production facility in Aachen, Germany, to expand its coatings business (1) and a $25 million investment to establish a manufacturing site in Costa Rica (2). The expansion in Germany, which Freudenberg announced in June 2024 will triple its manufacturing footprint with a new 130,000-ft

 facility in Alsdorf, near the existing site. The new facility houses ISO Class 7 cleanrooms, laboratories, and offices and will serve as a hub for R&D and production as well as drive innovation in medical coatings (1).

The new Costa Rica facility, announced in February 2024, is slated to come online in the beginning of 2025 and will be dedicated to assembling high-volume minimally invasive catheters for electrophysiology, vascular and structural heart therapies, and other medical devices requiring high-precision manual assembly. The first phase of construction comprises a build on 50,000 ft

 and the facility will house three ISO 7 cleanrooms. The company also expects to add another 50,000 ft

 to the site within three years of its opening. This added construction will quadruple Freudenberg’s total footprint in Costa Rica (2).

Of the Germany site expansion, Mark Ostwald, CEO of Freudenberg Medical, said in a company press release issued at the time, "The convergence of medical devices and drugs is inspiring a new generation of innovative products that fundamentally improve patients’ outcomes. With this innovation driven investment, we are strengthening our position as a strategic partner to our customers, offering vertically integrated solutions along the entire supply chain" (1).

Meanwhile, Róger Gómez, vice-president/general manager of Freudenberg Medical in Costa Rica, said of the Costa Rica facility expansion at the time it was announced, “The investment in this new site underlines Freudenberg Medical’s confidence in Costa Rica as an integral part of our global growth strategy. In the next three years, we will triple the number of employees from the current 300 to over 900 team members. Committed to diversity and inclusion, we offer equal opportunities to all” (2).

1. Freudenberg Medical. Freudenberg Medical Expands Coatings Business with New Production Facility. Press Release, June 11, 2024.
2. Freudenberg Medical. Freudenberg Medical Establishes Second Production Facility in Costa Rica. Press Release, Feb. 14, 2024.

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Freudenberg Medical has introduced custom single-use assemblies for silicone extrusion and molding for biopharma applications.

Freudenberg Expands Biopharm Product Portfolio with Addition of Custom Single-Use Assemblies

AbbVie has completed its acquisition of Cerevel Therapeutics, a clinical-stage biopharmaceutical company specializing in neuroscience diseases. Cerevel is now a part of AbbVie, AbbVie announced in an Aug. 1, 2024  press release. The acquisition, which AbbVie initially announced in December 2023, is valued at $45 per share in cash, or a total equity value of approximately $8.7 billion (1).

"AbbVie's acquisition of Cerevel strengthens our foundation in neuroscience and positions us to deliver sustainable long-term performance into the next decade and beyond," said Robert A. Michael, chief executive officer, AbbVie, in a company press release. "Our new Cerevel colleagues share our commitment to deliver meaningful change for patients living with neurological and psychiatric conditions. We are excited to welcome the talented Cerevel team to AbbVie."

Under the acquisition, AbbVie gains Cerevel's pipeline, which comprises multiple programs across several neurological and psychiatric conditions with significant unmet need, including schizophrenia, Parkinson's disease, and mood disorders. According to the press release, Cerevel's pipeline complements AbbVie's existing neuroscience portfolio.

Among Cerevel’s promising drug candidates is emraclidine, a potential best-in-class, next-generation antipsychotic. Emraclidine is a positive allosteric modulator (PAM) of the muscarinic M4 receptor that is currently being studied for treating schizophrenia. A Phase Ib study showed that emraclidine demonstrated promising efficacy and safety. It is currently completing two Phase II trials.

Tavapadon is a first-in-class dopamine D1/D5 selective partial agonist for managing Parkinson's disease. This late-stage drug candidate is currently in Phase III studies and has the potential to work as both a monotherapy and an adjunctive treatment. The efficacy and safety-tolerability profile for tavapadon could enable its utility in treating early Parkinson's disease and can be complementary to AbbVie's existing symptomatic therapies for treating advanced Parkinson's disease, according to the press release. Tavapadon met its primary endpoint in a pivotal Phase III study, and data from additional Phase III trials are anticipated to come out later this year.

Meanwhile, CVL-354 is a potential best-in-class kappa opioid receptor (KOR) antagonist currently in Phase I development. This drug candidate can potentially provide significantly improved efficacy and tolerability compared to existing treatments for major depressive disorder (MDD). Finally, darigabat, currently in Phase II development, is an alpha 2/3/5 selective γ-aminobutyric acid type A receptor PAM for treatment-resistant epilepsy and panic disorder.

The acquisition of Cerevel marks an additional multibillion-dollar transaction AbbVie has completed within this year. In February 2024, the company completed its acquisition of ImmunoGen (2), a 

 that added promising next-generation antibody drug conjugate drug candidates to AbbVie’s pipeline, boosting AbbVie’s presence in solid tumor therapeutics (3).

1. AbbVie. AbbVie to Acquire Cerevel Therapeutics in Transformative Transaction to Strengthen Neuroscience Pipeline. Press Release, Dec. 6, 2023.
2. AbbVie. AbbVie Completes Acquisition of ImmunoGen. Press Release, Feb. 12, 2024.
3. AbbVie. AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio. Press Release, Nov. 30, 2023.

This acquisition gives AbbVie clinical-stage assets from Cerevel’s pipeline that complement AbbVie's emerging neuroscience pipeline and branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

AbbVie Strengthens Neurological Pipeline with $8.7 Billion Acquisition of Cerevel Therapeutics

A new biotech company, Third Arc Bio, which specializes in the development of multifunctional antibodies that are optimized for T cell engagement across solid tumors and inflammatory and immunology (I&I) diseases, has raised $165 million in oversubscribed Series A financing. The company plans to use the funds to advance its drug development programs in clinical studies that address significant unmet needs in oncology and autoimmunity, Third Arc Bio announced in a July 23, 2024 company press release.

Since its initial launch in 2022 with seed financing from Omega Funds, the company has advanced multiple programs that are anticipated to enter the clinic starting in early 2025. The company’s leadership team has collectively brought 19 drugs to market from the discovery and development phases.

“With a powerful discovery engine and a stellar development team, the company is well-positioned to deliver best-in-class therapies and regimens,” said Peter Lebowitz, MD, PhD, CEO of Third Arc Bio, in the press release. “We are grateful for the strong support from Omega Funds and our investor syndicate, who believe in the value of our precise and targeted approach to modulating the immune response with advanced biologics.”

Third Arc Bio’s leadership team consists of:

Peter F. Lebowitz, MD, PhD, who joined as Third Arc Bio’s CEO in January 2024. Lebowitz has extensive drug development experience in his prior role as global head of Oncology R&D at Johnson & Johnson, which achieved 13 major new drug approvals with first and best-in-class medicines, according to the press release. Prior to Johnson & Johnson, Lebowitz also served in multiple leadership roles at GSK, including vice-president, global head of Oncology Early Clinical Development, and vice-president, medical development leader in Late Development at GSK. In those roles, he filed 10 investigational new drug applications (INDs) and played a crucial role in the global registration of two oncology medicines.

Sanjaya Singh, PhD, is founder and chief scientific officer of Third Arc Bio and has more than 25 years of experience in biotherapeutics. He has co-invented multiple immunology and immuno-oncology compounds, including risankizumab (Skyrizi). Singh’s prior roles include global head of Janssen Biotherapeutics, Johnson & Johnson, as well as at Boehringer Ingelheim, Biotherapeutics Discovery, and Tanox (acquired by Genentech). He is co-founder and scientific advisory board member of Aliada Therapeutics.

Joe Erhardt, PhD, chief operating officer, Third Arc Bio, has served for more than 20 years in roles ranging from early discovery through to late clinical development. He most recently served as vice-president, global head of Oncology Discovery and External Innovation, Johnson & Johnson. In his prior roles, Erhardt had operational oversight of expansive portfolios as well as licensing and collaboration for oncology discovery and early development. He has delivered a significant number of internal and external candidates in discovery and clinical pipelines across different modalities, including T cell redirection, T cell co-stimulation, antibody drug conjugates, and targeted radiotherapy.

“The Third Arc Bio team has an outstanding track record of developing impactful medicines, including multiple approved drugs that have redefined standard-of-care in oncology and I&I,” said Arjun Goyal, MD, co-founder and managing director of Vida Ventures, which led the Series A financing, in the press release. “We are tremendously excited to lead this round alongside a high-caliber syndicate of life science and strategic investors at a pivotal time for the company’s growth. With Third Arc’s leading portfolio of best-in-class biologics, multiple INDs planned for 2025, and an extraordinary team of drug developers, the company is poised to create bold new treatments leveraging T cell biology for patients globally.”

Engineered T cells are emerging as highly effective treatments, particularly for hematological cancers. This is evidenced by the hundreds of clinical programs that are underway to expand the efficacy, safety, and applications of this modality, otherwise known as a “living drug” (1).

1. Kirouac, D.C.; Zmurchok, C.; Morris, D. Making Drugs from T cells: The Quantitative Pharmacology of Engineered T Cell Therapeutics. 

With the Series A funding, the new biotech company will advance the development of enhanced biologics for treating solid tumors and inflammatory and immunology diseases.

Third Arc Bio to Advance Biologic Drug Development Programs on $165 Million Funding 

STADA and Alvotech have launched Uzpruvo in Europe, marking the first approved biosimilar to Stelara (ustekinumab) in the European market, according to a July 22, 2024 company press release. Uzpruvo is now available across a majority of European countries, including the largest markets in the region where pricing and reimbursement approvals have been secured to ease the biosimilar’s market entry. 

This launch follows close on the heels of the expiry of exclusivity rights related to the European reference molecule patent. The availability of a biosimilar ustekinumab offers expanded access to patients, physicians, and payers for a therapy to treat certain indications in the gastroenterology, dermatology, and rheumatology disease areas. The companies expect to conduct additional launches in other European countries over the coming months following national price approvals and utilizing a fully European supply chain, according to the press release.

“Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets promotes access by creating competition,” stated Peter Goldschmidt, STADA’s CEO, in the release. “This opportunity to improve patient access through wider usage of a life-changing biological treatment emphasizes STADA’s purpose of Caring for People’s Health as a Trusted Partner.”

The European Commission approved Uzpruvo in January 2024, making the product the first ustekinumab biosimilar to be approved in Europe with equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the reference biologic, Stelara (1). Uzpruvo is indicated for treating Crohn’s disease and psoriatic arthritis in adults and for treating plaque psoriasis in adults and children aged from six years. Uzpruvo is not currently approved to treat ulcerative colitis, however, because the originator biologic still holds exclusivity in this indication.

“With comparable safety, efficacy, and immunogenicity, Uzpruvo gives clinicians an opportunity for a seamless and simple switch for their patients, who can benefit from a thinner needle and latex-free syringe,” commented Bryan Kim, STADA’s Global Specialty head, in the press release.

Uzpruvo is offered in a pre-filled syringe that has a thinner needle than the reference biologic. The biosimilar is also latex-free to minimize the risk of allergic reactions. According to the companies, Uzpruvo was developed and is manufactured and packaged wholly within Europe. It has a shelf life of 36 months.

Ustekinumab is the second immunology biosimilar to reach the market through the STADA and Alvotech partnership. In December 2022 the companies launched Hukyndra a high-concentration, citrate-free adalimumab therapy, a biosimilar to Humira, on the European market (2).

Meanwhile, in June 2024, the partners expanded their collaboration by entering into a development, manufacturing, and marketing alliance for a proposed biosimilar candidate to Prolia/Xgeva (denosumab), a human monoclonal Immunoglobulin G2 antibody for treating osteoporosis in women and bone loss in men (3,4). Under this agreement, Alvotech is responsible for the development and manufacturing of biosimilars within the partnership at its Reykjavik, Iceland, facility.

Union Register of Medicinal Products for Human Use

 (accessed July 29, 2024).
2. Alvotech. Alvotech and STADA Broaden Access to Hukyndra Adalimumab Biosimilar in Europe. Press Release, Dec. 7, 2022.
3. Alvotech. Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership. Press Release, June 11, 2024.
4. EMA. 

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

First Approved Stelara Biosimilar Launched in Europe by STADA and Alvotech

Scorpius Holdings, an integrated contract development and manufacturing organization (CDMO), is prepared to launch its first current good manufacturing practice (CGMP) mammalian manufacturing campaign at its manufacturing facility in San Antonio, Texas, in the 2024 third quarter. The launch follows the company's expansion efforts for its biomanufacturing capabilities, especially in the area of mammalian cell culture for advanced biopharmaceuticals, according to a July 24, 2024 press release.

The company previously started up CGMP operations at its microbial manufacturing facilities, and the start of mammalian CGMP manufacturing campaigns signifies a strategic company milestone in its CDMO operations. The San Antonio site hosts a dedicated mammalian cell culture facility with CGMP-compliant controlled cleanrooms that can be tailored to allow for adaptable manufacturing solutions, according to a company press release.

“I am extremely proud of what our team has accomplished in a short period of time. Our manufacturing and quality teams have worked exceptionally hard to get our mammalian facilities operational in less than two years, well ahead of the typical timing for such complex buildouts. Scorpius is now extremely well-positioned to support a wide range of early stage clinical programs," said Jeff Wolf, CEO of Scorpius, in the press release.

The facility’s design includes cleanrooms with mobile equipment, which enables customizable configurations for the specific needs of individual projects. Scorpius has secured bookings for additional CGMP activities in the mammalian facility for 2025, according to Wolf in the press release.

The San Antonio site underwent significant expansion in May 2024 as Scorpius grew its operational footprint. The expansion included new storage space and a testing facility. Warehouse space was increased more than sevenfold, from approximately 3000 ft2 to approximately 22,000 ft2 with the expansion. The warehouse includes specialized storage areas with temperature control between -20 °C and -80 °C for raw materials as well as spaces designated for contained sampling and quality control testing. The facility will also accommodate bulk drug substance storage to ensure that products are stored under optimal conditions throughout the development and production cycles. (1).

The expanded facility will include a robust stability program meant to bolster Scorpius' service offerings by allowing the company to provide in-house stability storage capabilities. The company intends to foster smooth transitions into onsite testing with the enhanced in-house stability storage.

"These new capabilities enable us to offer our clients continuity through their supply chain and meet their needs from process development through drug substance release. This strategic expansion reflects our commitment to excellence and our dedication to supporting our clients’ overall needs," Wolf said in a May 20, 2024 company press release.

1. Scorpius Holdings. Scorpius Holdings Announces Major Expansion in San Antonio with New State-of-the-Art Storage and Testing Facility. Press Release, May 20, 2024.

Scorpius Holdings is set to launch its first CGMP manufacturing campaign at its San Antonio, Texas, facility for mammalian cell culture in the 2024 third quarter.

Scorpius Holdings Prepares for Mammalian CGMP Manufacturing Campaign Launch in Texas Facility

Oncology company BeiGene has opened its new biologics manufacturing facility at the Princeton West Innovation Campus in Hopewell, NJ. The $800 million facility represents the company’s flagship facility in the United States and also houses a clinical R&D center. The investment is part of the company's strategic goal to expand its integrated manufacturing and R&D footprint in the US, according to a July 23, 2024 company press release.

BeiGene has more than 30 molecules at clinical- or commercial-stage development. The new 42-acre facility gives the company flexibility to scale production of these drug candidates presently and in the future to meet cancer patient needs. The Hopewell site comprises approximately 400,000 ft2 of space dedicated to commercial-stage biologic manufacturing capacity and includes additional space to expand over time as BeiGene’s pipeline matures.

The facility strengthens BeiGene’s late-stage research and clinical development capabilities. The company’s oncology pipeline addresses 80% of global cancers using modalities such as targeted degraders and antibody drug conjugates as well as monoclonal antibodies and traditional small molecules. The new facility enables the company to produce at scale, which reduces costs and ensures supply chain resiliency. The company aims to avoid global disruptions, protect capacity, and rapidly adapt to the latest innovative modalities, according to a company press release.

“BeiGene has experienced unprecedented global growth, and the addition of our facility at the Princeton West Innovation Campus adds manufacturing and clinical development capabilities that will further strengthen our differentiated strategy, which leverages speed, efficiency, and technology to advance quality medicines faster for patients,” said John V. Oyler, co-founder, chairman, and CEO of BeiGene, in the press release. “We are proud to be a part of New Jersey’s biopharmaceutical community that is rich in research and development and manufacturing talent. We look forward to deepening our relationships with key regional research institutions as we advance our robust pipeline of next-generation hematology and solid tumor medicines and continue to emerge as a leading global oncology innovator.”

The company expects to create hundreds of skilled high-tech jobs at the site by the end of 2025. BeiGene initially announced its 

 on the Hopewell site in November 2021 (1).

“I am thrilled by BeiGene’s contribution to our state’s thriving biopharmaceutical sector,” said Governor Phil Murphy, in the release. “The opening of BeiGene’s flagship campus underscores our commitment to fostering innovation and creating high-tech jobs in the Garden State. We look forward to the positive impact BeiGene will have on our economy and the advancements they will bring to cancer treatment. This significant investment highlights New Jersey’s role as a global leader in pharmaceutical manufacturing, research, and development. We are proud to support BeiGene’s mission to develop affordable and accessible treatments for cancer patients worldwide.”

As part of BeiGene’s sustainability efforts, the company has invested in sustainability measures both in the buildings and surrounding the 42 acres of the site. These measures include a heating and cooling system that employs recycled wastewater from the onsite wastewater treatment plant for the cooling towers and solar-ready capability.

1. BeiGene. BeiGene Closes on Property for New U.S. Manufacturing and Clinical R&D Center. Press Release, Nov. 23, 2021.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.