Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Delving into Biopharmaceutical Development and Manufacturing

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews experts from Biosynth and the University of Maryland about biopharmaceutical drug development and manufacturing. During the discussion, Hans de Backer and Peter Timmerman from Biosynth and Anupreet Kaur from the University of Maryland go into detail about the evolution of biopharmaceutical development, highlighting challenges and potential future trends. Additionally, the intricacies of monoclonal antibodies and the complexity of the supply chain are explored.

Post Doctoral Associate, Dr. Robert Brinson Research Group, Institute for Bioscience & Biotechnology Research (IBBR), National Institute for Standards and Technology (NIST), University of Maryland.

Anupreet is a dedicated structural biochemist with more than seven years of experience in structural biology, specializing in protein structural, dynamic and interaction studies. Her strength includes investigating proteins dynamics or conformational exchange using High Resolution Nuclear Magnetic Resonance (NMR) spectroscopy. Anupreet completed her PhD in India and later joined George Washington University as a Post doctoral Research fellow where she did protein engineering to enhance its ligase activity. Currently in IBBR, Anupreet is elucidating the biophysical mechanisms of pharmaceutically relevant excipient-Fab Interactions. Her ultimate aim is to explore the dynamics of monoclonal antibodies at atomic level and characterize the conformational changes in various pharmaceutically relevant formulations using NISTmAb, reference antibody and NIST-Fab with the help of advanced NMR.


Hans received a BSc and MSc in Industrial Engineering and Management Science from the Eindhoven University of Technology in the Netherlands. He spent over seven years at Roland Berger Strategy Consultants, specializing in life sciences. In the four years after that, he spent time in API operations at Aspen Pharmacare, where he built his operational management expertise, first as a Program Manager of a company-wide IT transformation, and later as a Manager of Technical Affairs. In 2019, he joined Pepscan as CEO, which became part of the Biosynth Group after three years, and now Hans is the Head of the Peptide Division at Biosynth.

Peter, Head of Peptide Science at Biosynth, joined the group following the acquisition of Pepscan in 2022, where he had served as CSO since 2012. He drives advancements in protein mimicry for peptide drug discovery programs. Timmerman is the inventor of CLIPS technology and held a chair as a Professor in Protein Mimetic Chemistry at the University of Amsterdam from 2007-2022. He obtained his MSc Chemistry degree from Vrije Universiteit (Amsterdam) and earned his PhD cum laude from the University of Twente. Timmerman has co-authored over 100 scientific papers in peer-reviewed journals.

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

 Small Molecule APIs, Excipients, and Formulation

Videos

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, Pharmaceutical Technology Group, interviews experts from Biosynth and the University of Maryland about biopharmaceutical drug development and manufacturing.

Drug Digest: Delving into Biopharmaceutical Development and Manufacturing

Thermo’s DNAPac RP HPLC columns | Image Credit: Thermo Fisher Scientific

The Thermo Scientific SurePac Bio 550 SEC MDi columns enable fast separations of adeno-associated virus (AAV) monomers and aggregates. The columns are designed with 3 µm monodisperse particles and inert (MDi) column hardware aimed at providing superior AAV monomer retention and higher resolution of aggregates in cell and gene therapies. 

Editor’s note: this article was published in the Aug. 1, 2024 issue of 

These columns offer fast run times, optimal separation efficiency, and reliable results with the goal of accelerating time-to-market for novel therapeutics. In addition, Thermo’s DNAPac RP HPLC columns (pictured here) are offered in semi-preparative formats to enable scalability in the development of DNA/RNA oligonucleotides. The DNAPac RP semi-preparative columns are designed so that laboratories can navigate the expanding field of oligonucleotide therapies and precision medicine. The DNAPac RP semi-preparative column utilizes unique chemistry for enhanced performance across wide ranges of pH, temperature, and mobile-phase compositions, offering precise separations and sample purification.

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Feliza Mirasol is the science editor for 

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

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

The US Pharmacopeia (USP) announced on July 26, 2024 that its Microbiology Expert Committee has approved the inclusion of Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents into the

 United States Pharmacopeia–National Formulary (USP–NF). 

The chapter permits the use of non-animal-derived reagents for endotoxin testing; the finalized chapter will be published for early adoption in November 2024 before becoming official in May 2025. The new chapter is part of USP’s commitment to expanding the use of animal-free methods and materials.

Endotoxins may cause irreversible side effects and even death in severe cases at sufficient concentrations in the bloodstream (1). Bacterial endotoxins are found in the outer cell membrane of Gram-negative organisms and are known to be one of the most potent toxins. “These toxins are harmless outside of the body and in the alimentary canal. They are extremely potent, however, once introduced in the bloodstream or intrathecally,” Allen L. Burgenson, Testing Solutions, Lonza Pharma & Biotech, said (1).

“Bacterial endotoxins (also referred to as pyrogens) have the capacity to induce a high fever,” said John Dubczak, general manager, Microbial Solutions, Charles River Laboratories (1). “A large enough dose of endotoxin can lead to lung and kidney failure, intravascular coagulation, and a systemic inflammatory response that can lead to septic shock and death.”

Therefore, endotoxin testing is an important part of the quality and safety steps taken in the manufacture of certain sterile pharmaceutical products. Techniques for bacterial endotoxin testing using non-animal derived reagents are provided in the new chapter. Specifically, the new chapter discusses methods using both recombinant cascade (rCR) and recombinant Factor C (rFC) reagents. It also gives information on how to incorporate the methods into quality testing.These new techniques are in addition to those found in Chapter <85> Bacterial Endotoxins.

“Chapter <86>is intended to provide manufacturers with the information needed to use non-animal derived reagents. Manufacturers that currently use limulus amebocyte lysate (LAL) for endotoxin testing can continue to do so and Chapter <86> has no impact on them,” USP said in a press release (2).

One of the main endotoxin tests, LAL assay “works via the reaction of the LAL reagent-an aqueous extract of blood cells from the horseshoe crab-with bacterial endotoxins and lipopolysaccharides” (1). While the LAL test is an animal-derived test, and the animal itself is not tested upon, the desire to reduce animal use in testing has influenced the pharma industry, which resulted in the LAL test replacing the previous standard Rabbit Pyrogen Test. The LAL test is an animal-derived test, meaning the animal itself is not tested upon (1). This change prevented the use of hundreds of thousands of rabbits per year. There has also been a commitment to conserve the horseshoe crab. “Work has included sustainability partnerships to enhance the horseshoe crab population along the mid-Atlantic shores,” said Victoria Watson, laboratory manager, Microbiology at Wickham Labs. “Such projects have focused on increasing the survival rate of the horseshoe crab in early stages of life. Eggs are collected, and the crabs are grown in predation-free, controlled environments then released into their natural environment when older and stronger” (1).

Thomas, F. Putting Endotoxins to the Test. 

https://www.pharmtech.com/view/putting-endotoxins-test

USP. Expert Committee Approves Endotoxin Testing Using Non-animal Derived Reagents. Press Release. July 26, 2024.

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

USP Permits Use of Non-Animal-Derived Reagents for Endotoxin Testing

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

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - stock.adobe.com

SpotSee, a Dallas, Texas-based company that manufactures visual indicators and other types of monitoring devices for a wide range of industries, announced in a press release on July 24, 2024 that its HemoTemp II Blood Bag Temperature Indicator and HemoTemp II Activator had both received an accreditation of “Standards-Compliant” from the Association for the Advancement of Blood & Biotherapies (AABB) (1).

“The AABB is recognized worldwide as a symbol of authority and distinction,” the press release said. “The organization is committed to its core objectives of providing high standards of safety for patients, donors, and facilities. AABB member institutions displaying the AABB accreditation logo are recognized globally for providing quality products and services.”

In the case of the two HemoTemp II products, a thorough review by AABB gave them high marks for quality in equipment and both process and document control, according to SpotSee (1).

“SpotSee sensors are carefully designed with quality in mind,” Tony Fonk, SpotSee president and CEO, said in the press release. “Earning this accreditation and seal of approval communicates to the public that our life science products are trustworthy, reliable, and of the highest quality.”

The blood bag temperature indicator, which is an FDA-approved medical device, is a liquid crystal combination irreversible blood temperature indicator and reversible thermometer for the measurement of blood during transit, and also storage outside the blood bank (1). According to SpotSee, the reversible portion acts like a blood bag thermometer, while the irreversible part warns the user if the blood’s core temperature has exceeded an approximate range of 6 ºC to 10 ºC.

“After activation, the irreversible portion will change color from blue to a non-blue color as the blood temperature increases and as time passes,” SpotSee explains further on the indicator’s product page (2). “Once the indicator has lost its blue color, it will not return to its original color even if the blood unit is re-cooled. This ensures the user of the time and temperature history of the unit.”

A tan color indicates that the temperature is in the lower portion of the desired range, while green signifies it is in the middle (2).

The activator, meanwhile, a block module heater, provides uniform temperature for the purpose of reliably and accurately activating a sensor also bearing the HemoTemp II name (1).

HemoTemp II is the proprietary brand name of SpotSee’s line of blood bag indicators and activators, as seen on a page on the SpotSee website devoted to the company’s offerings of temperature-related products (2). The blood bag temperature indicators are sold in packs of 40, or a larger order consisting of a case of five boxes of 40 indicators each.

SpotSee said that the indicator should not be used as the “sole indication of clinical acceptability of blood for patient infusion,” but rather a tool in the overall kit of a blood temperature monitoring program.

1. SpotSee. “SpotSee’s HemoTemp II Receives Standards Accreditation From AABB.” Press Release. July 24, 2024.
2. SpotSee. Blood Bag Indicators and Activators. 

shop.spotsee.io/temperature_indicators/blood_indicators

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

Two SpotSee Products Receive AABB Standards Accreditation

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At its meeting held July 22–25, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive opinions or granted marketing authorizations to 14 medicines, EMA said in a press release issued July 26 (1).

One negative opinion was given for a drug for the intended treatment of Alzheimer’s disease; 11 others received extensions of their various therapeutic indications.

Anzupgo (delgocitinib), which treats moderate to severe chronic hand eczema in adults for who topical corticosteroids were ineffective, was granted a marketing authorization. So too were Vyloy (zolbetuximab), treating a form of stomach cancer known as gastric or gastroesophageal junction adenocarcinoma, and Iqirvo (elafibranor), given a conditional authorization for the treatment of primary biliary cholangitis, which is a chronic, progressive autoimmune disease that can cause liver damage, according to CHMP (1).

Additionally, the following three were given positive opinions:

Kayfanda (odevixibat) was issued a positive opinion under exceptional circumstances, for treatment of cholestatic pruritis in patients with Alagille syndrome—a rare and life-threatening genetic disorder with numerous clinical manifestations

Loqtorzi (toripalimab), for treating nasopharyngeal and esophageal squamous cell carcinomas

Vevizye (ciclosporin), which treats adult patients with moderate to severe dry eye disease that has not improved with treatment with tear substitutes (1).

Johnson & Johnson was one of the first companies to respond to the CHMP announcement, as its Yuvanci (macitentan/tadalafil) was given a positive opinion for treatment of pulmonary arterial hypertension (PAH) (2).

“PAH is a devastating disease affecting people of all ages and the burden the condition places on the daily lives of people living with it should not be underestimated,” Tamara Werner-Kiechle, MD, of Johnson & Johnson Innovative Medicine, said in a press release.

Six biosimilar medicines received positive opinions: Eksunbi, Fymskina, and Otulfi (all ustekinumab), for treatment of plaque psoriasis (both adult and pediatric), psoriatic arthritis, ulcerative colitis, and Crohn’s disease; Ituxredi (rituximab), for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis; Ranibizumab Midas (ranibizumab), for treatment of neovascular or “wet” age-related macular degeneration and other visual impairment issues; and Tuznue (trastuzumab), for treatment of breast and gastric cancers (1).

Extensions of therapeutic indications were given to Arexvy, Braftovi, Edurant, Keytruda, Mektovi, Opsumit, Padcev, Rybrevant, Slenyto, Spevigo and Tecentriq (1).

The negative opinion was given to Leqembi (lecanemab), which is intended to treat Alzheimer’s disease. CHMP did not grant a marketing authorization for Leqembi because it did not consider the effects of the drug in delaying cognitive decline to outweigh the risk of serious side effects, including frequent amyloid-related imaging abnormalities, which may involve swelling and potential bleeding in the brain (1).

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
2. Janssen-Cilag International NV. Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH). Press Release. July 26, 2024.

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

CHMP Recommends 14 Medicines for Approval at July Meeting

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.

BeiGene Opens New Jersey-Based Biologics Manufacturing and Clinical R&D Site

FDA has issued a Federal Register notice, dated July 24, 2024, entitled “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments,” seeking input from interested parties as to whether biosimilar product development would be better served in either of two ways: a focus on guidance documents that are product class-specific, addressing development issues that are common and apply broadly to products such as monoclonal antibodies, or an emphasis on developing product-specific documents—for example, for adalimumab (1).

This choice is one of two main questions FDA would like answered by the input it hopes to receive from industry on this notice, the other being whether FDA should focus on development of guidance documents, whether product-specific or product class-specific, in cases of biological products for which there are no approved biosimilars. Or alternatively, FDA asks, would it be of use to the biosimilar product development community to continue to develop guidance on biosimilar development programs even after one, or more, biosimilar products have been approved for a biological product or class of products (1)?

Following enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA updated its Biosimilars Action Plan and said these questions are now arising as the administration reexamines the best possible path to advancing development of new biosimilar products (1,2). Concentrating on product-specific guidance documents, FDA said, would be a development approach similar to the Generic Drug User Fee Amendments (GDUFA) program (3). According to FDA, under the conditions set forth by GDUFA, there are currently more than 2000 product-specific guidance documents from which to model biosimilars guidance (2).

The Biosimilars Action Plan (BAP), first released in 2018, has four overarching goals, each with its own subset of aims. FDA said in the five-plus years since the initial BAP report, it has accomplished most of the goals set forth and is now “modernizing the Agency’s strategic priorities” (2).

The originally stated goals are: to improve efficiency of the development and approval processes for biosimilars and interchangeable products; maximize both scientific and regulatory clarity for the community; develop effective communications to increase understanding among stakeholders; and support a robust, competitive marketplace (2).

Both electronic and written comments, data, or information are being accepted and, to be considered, must be received by FDA or the 

 portal on or before Oct. 23, 2024 (3). All submissions must include the docket number FDA-2024-N-3228. Although the notice and docket are publicly available, comments and other information can be volunteered confidentially; instructions on how to do this appear in the Federal Register notice.

1. FDA CDER Small Business and Industry Assistance. FDA Seeking Comments on Product Class-Specific vs. Product-Specific Guidances for Biosimilars. Press Release, July 24, 2024.
2. FDA. Biosimilars Action Plan. 

fda.gov/drugs/biosimilars/biosimilars-action-plan

, Apr. 26, 2024 (accessed July 25, 2024).
3. FDA. 

Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

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