Manufacturing – Life Sciences Voice

Roche offers $50 billion to US pharma production in response to the tariff threat

Editorial Team — Thu, 24 Apr 2025 12:24:30 +0000

Roche, the drugmaker giant, announced its interest in investing $50 billion over five years in new and existing facilities across multiple states to expand U.S. drug production.
Roche announced this capital investment during an uncertain period involving U.S. trade policies destabilizing global commerce and affecting biopharmaceutical companies. Roche declared its intention to construct facilities for obesity medications, gene therapies, and continuous glucose monitoring devices alongside building a new research and development center. Several current facilities belonging to Roche will be expanded under their strategic development plan.
Roche plans to use the investment money to create a drug export surplus from America, which matches the existing diagnostic product export model.
This year marks the fifth pharmaceutical giant to promise major increases in its U.S. drug manufacturing facilities after Johnson & Johnson, Eli Lilly, Merck & Co., and Novartis. The combined investments of the five companies amount to more than $160 billion for American drug manufacturing throughout the next few years.

These projects include creating gene therapy production facilities in Pennsylvania and building an AI research center in Massachusetts under Roche’s planned investment. The funds will finance operational improvements for current manufacturing sites, which produce pharmaceuticals as well as medical diagnostic equipment. The pharmaceutical facilities operated by those companies exist throughout Kentucky, Indiana, New Jersey, Oregon, Arizona, and California.
Roche CEO Thomas Schinecker announced in his statement that the company maintains robust support for U.S. research and development, along with manufacturing activities. Roche stands with pride as a company that has maintained operations in the United States since 1913, which serves as the essential foundation for building jobs and innovations while establishing intellectual property throughout all branches of pharmaceuticals and diagnostics in America.
The Trump administration plans to introduce new pharmaceutical tariffs on pharmaceutical companies, which may take effect within the upcoming weeks. Senior White House officials intend to impose levies on pharmaceutical companies to force them to bring back essential drug manufacturing operations and raw material production to U.S. facilities.
Pharmaceutical companies like Roche, together with their peers, attempt to counter coming threats by making new investment announcements in the United States. The completion of these new facilities, together with their drug import reduction effect, will take several years to materialize.

The Vacaville biologics manufacturing facility of Roche was sold to Lonza under a $1.2 billion transaction in 2024. The closing of facilities led to total cost expenditures amounting to 827 million Swiss francs or $940 million during 2024 for the company. Roche invested 1.7 billion Swiss francs in the pharmaceutical division’s property, plants, and equipment, and dedicated 1.8 billion Swiss francs to equivalent costs with its diagnostics business.

Chinese CRO GemPharmatech Expands in San Diego as FDA Reevaluates Animal Testing Requirements

Editorial Team — Wed, 23 Apr 2025 16:49:55 +0000

The Chinese contract research organization (CRO) GemPharmatech continues to increase its U.S. facilities by building a new center in San Diego which strengthens its market reach within the region. The new site combines laboratories with several genetically engineered mouse models to improve preclinical research support at the company. The company released its announcement as part of its continuing U.S. operational expansion while bringing sophisticated research capabilities closer to customers in America.
The San Diego site is an extension of GemPharmatech’s U.S. headquarters, offering services such as lab space rental, mouse breeding, and in vivo preclinical research support. Since 2023, GemPharmatech has been preparing for this expansion from its headquarters in Nanjing, China, aiming to broaden its market reach in the United States.

Dr. Brandy Wilkinson emphasized in a press release that the new facility enables American customers to immediately benefit from pharmacology services and technical expert support that helps speed up new therapy development. The facility also offers direct access to the world’s largest mouse model library, a key asset for future drug development.
This new facility opened its doors right after the FDA declared that it will eliminate mandatory animal testing needs for new monoclonal antibodies. The FDA’s announcement sparked an industry-wide reassessment, as CROs and their competitors navigate evolving drug testing regulations.
GemPharmatech reaffirmed its commitment to global scientific research through its mouse models while adapting to changing market demands. A company spokesperson said GemPharmatech continues to monitor market trends and invest in the development of alternative testing solutions as needed.
The decision by the FDA has prompted various organizations within the CRO field to start making adjustments. Charles River Laboratories declared its intention to develop innovative solutions such as virtual control groups and artificial intelligence technologies for decreasing animal utilization during research activities. The company made public in April 2024 its broader initiative to add human organoids along with computer simulations to new alternative methods (NAMs) within its drug development workflows. Stock performance at Charles River took a substantial loss amounting to 27% following the FDA’s statement based on Macquarie Equity Research analysis.
Although Charles River did not provide insight into its stock movement a company representative confirmed that NAMs present possibilities yet they need extensive validation to adequately substitute animal models throughout drug development.

Emulate CEO Jim Corbett predicts that Contract Research Organizations will eventually embrace non-animal testing solutions because of rising market demand. The FDA made a choice that he saw as motivating the pharmaceutical industry to embrace new technologies because he predicted supply and demand forces would lead to inevitable technological changes..

Merck develops $1B Gardasil production plant in North Carolina

Editorial Team — Fri, 14 Mar 2025 07:27:53 +0000

The Durham complex of Merck now operates a new $1 billion, massive 225,000-square-foot bulk substance manufacturing facility to produce bulk ingredients for Gardasil, its major hit HPV vaccine.
Merck constructed a new manufacturing facility on its established 262-acre campus, which has served as headquarters since 2004. The facility produces vaccines, including Gardasil, and prevention medications for chickenpox, measles, and rubella viruses.
Last year, the manufacturing complex manufactured 70 million doses and plans to expand its production this year, as per a Merck spokesperson in an email dialogue. The campus now employs more than 1,000 people.

The manufacturing center gained widespread attention during the coronavirus era because Merck teamed up with Johnson & Johnson to produce substance materials for their unsuccessful COVID-19 vaccine using a Department of Health grant worth $105 million.
The arrival happens at a time when American biopharmaceutical companies are exploring the possibility of expanding their domestic production bases. President Donald Trump announced his plans to enlarge existing trade restrictions on China, Canada, and Mexico, and he threatened additional taxes or tariffs targeting pharmaceutical products from abroad at 25%.
On the streets of Washington two weeks ago, Eli Lilly announced its $27 billion strategy to construct four new U.S.-based manufacturing sites, which would supplement its existing domestic installations.
Since 2018, Merck has dedicated more than $12 billion to building new American facilities for research and manufacturing operations. The company dedicated a planned $8 billion towards building U.S. capital facilities, which will extend until 2028.
Sanat Chattopadhyay from Merck’s manufacturing team declared in their release that the Durham expansion defines an important achievement in their mission to improve U.S. production infrastructure.
Two weeks prior, the state investment board of Delaware had supplied Merck with a $30.2 million grant to develop their Chesnut Run Innovation & Science Park facility outside of Wilmington. The company proceeds with reviewing its selection following the grant allocation that emerged from the local planning and development initiative.

Durham’s new vaccine site contains advanced functionalities that involve data analytics and both generative AI and 3-dimensional printing, according to Merck’s statements. Digital twin technology within the facility uses virtual modeling to evaluate process modifications before their implementation date while providing employee training resources.
The Durham location serves as a TICE BCG production center for bladder cancer medication, which addresses years of supply shortages through capacity expansion facilities. The company stated through email Tuesday that the project should reach completion by the end of this year.

Merck Increases Vaccine Production With New $1B Manufacturing Facility in North Carolina

Editorial Team — Fri, 14 Mar 2025 07:22:25 +0000

Merck has inaugurated a fresh $1 billion, 225,000-square-foot manufacturing site at its extensive compound in Durham, N.C., intended for the production of bulk material for its very successful HPV vaccine, Gardasil.

Merck constructed the new facility on its 262-acre property, which it has inhabited since 2004, where the pharmaceutical giant manufactures several vaccinations, including those for rubella, chickenpox and measles.

The facility produced over 70 million units last year, with projections indicating a rise this year, according to a Merck representative via email. The complex now employs over 1,000 individuals.

The facility garnered national prominence during the COVID pandemic when Merck and J&J obtained a $105 million government funding in an unusual collaboration among major pharmaceutical companies to produce bulk material for J&J’s unsuccessful COVID-19 vaccine.

The move occurs as U.S. biopharmaceutical firms contemplate increasing domestic production of their goods. President Donald Trump has cautioned about the possibility of extending tariffs—beyond those now levied on Canada, China and Mexico—on imports from other nations, including a prospective 25% tax on medicines.

A couple of weeks ago in Washington, Eli Lilly announced a proposal to invest $27 billion in the construction of four new production facilities in the U.S., in addition to its existing substantial domestic network.

On Tuesday, Merck said that it had invested over $12 billion in enhancing its manufacturing and research and development capabilities in the country since 2018. The corporation has allocated an additional $8 billion for capital expenditure in the U.S. until 2028.

Sanat Chattopadhyay, Merck’s manufacturing head, said in a statement that the expansion in Durham represents a key milestone in their endeavours to enhance production as well as manufacturing capacities in the U.S.

A few weeks ago at the Chestnut Run Innovation & Science Park, Merck was awarded a grant of $30.2 million by the state investment board of Delaware. The money will allow Merck to establish a facility located outside of Wilmington. The funding was awarded as part of a process that included local planning and development, and the firm is continuing to investigate the other alternatives available to it.

Merck said that the new vaccination facility in Durham is outfitted with sophisticated technologies, including generative AI, data analytics and 3D printing. It encompasses digital twin technology, an electronic model capable of simulating process alterations prior to implementation and assisting in staff training.

Moreover, at the Durham location, Merck is constructing a facility to enhance the company’s capacity to manufacture the bladder cancer medication TICE BCG, a freeze-dried treatment delivered by catheter that has had persistent supply challenges for years.

Glenmark Issues Recall of Almost 1.5M Bottles of Generic ADHD Medication

Editorial Team — Thu, 06 Mar 2025 21:06:44 +0000

The drug company Glenmark Pharma, which is located in India and has been the subject of a number of recalls in the past few years, has issued yet another one to add to its list.

In this particular instance, the product recall encompasses around 1.48 million bottles of the generic medicine atomoxetine, which is used to treat attention-deficit/hyperactivity disorder (ADHD).

Strattera, the branded form of the medicine, was sold by Eli Lilly in the past; however, in 2023, with the introduction of generic versions, the company stopped selling all strengths of the drug.

Atomoxetine is a focused norepinephrine reuptake inhibitor (sNRI), in contrast to all of the stimulant-based medications used to treat attention-deficit/hyperactivity disorder, such as Adderall and Vyvanse.

According to the Food and Drug Administration (FDA), the recall was initiated because numerous batches of Glenmark atomoxetine included amounts of N-nitroso atomoxetine, which is a potential carcinogen.

On the homepage for its Enforcement Report, the FDA said that the voluntary pull, which started on January 29, encompasses bottles of the medicine with dosages that vary from 10 mg to 100 mg. Glenmark’s plant in Goa, India, was responsible for the production of the ADHD medications, which were subsequently distributed throughout the country.

As a result of problems with both the manufacturing process and the labeling, Glenmark has been subjected to a number of recalls in recent years.

In June 2024, the firm decided to recall around 47 million capsules, comprising over 110 batches of 750 mg potassium chloride capsules. It was determined that the recall was due to concerns that the capsules did not dissolve correctly.

In December, due to the presence of unacceptably large quantities of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem, the firm decided to recall over 90,000 bottles of the high blood pressure medication diltiazem hydrochloride in pill and extended-release versions.

As part of separate actions taken in 2023, Glemark called back over 1,000 bottles of trandolapril and verapamil hydrochloride extended-release tablets, which are prescribed for the management of high blood pressure; 37,000 bottles of Indomethacin, which is a non-steroidal anti-inflammatory medicine employed to treat agony and arthritis manifestations; and five lots of Naproxen, which is used to decrease fever or alleviate mild pain.

Last year, it issued a recall for more than 98,000 packets of mometasone furoate topical solution, which is a corticosteroid lotion used to treat skin diseases such as psoriasis, eczema, allergies, and itches.

Failed facility inspection by partners places Atara’s Ebvallo pipeline candidate on clinical hold in the United States

Editorial Team — Fri, 24 Jan 2025 02:09:47 +0000

Atara Biotherapeutics has now faced a second setback after getting a complete response from the FDA through its T-cell immunotherapies pipeline. Atara’s EBV+PTLD and ATA3219 therapy projects face study delays after the FDA required a clinical hold due to inspection findings at the European factory.
The suspension affects both drugs as new patient screening and enrollment activities stop across all development programs. Atara said they will continue treatment for specific patients in ongoing study protocols.
Atara blamed the clinical hold on the FDA’s poor inspection of a third-party manufacturer that showed in last week’s CRL for Ebvallo. ATA3219 drug material is not produced at the facility under warning but the raw materials for its manufacturing show the same quality deficiencies noted in the warning letter.

The Thousand Oaks location run by Fujifilm Diosynth Biotechnologies remains free from production delays due to the hold and CRL. Fujifilm continues to form an essential part of Atara’s product production plan.
CEO Cokey Nguyen stated that Atara is moving fast to meet FDA requirements for lifting the clinical hold.
Atara shareholders received two pieces of news today: first the CRL for Ebvallo then the clinical hold. The company noted the withdrawal stemmed from one facility inspection problem while assuring product effectiveness and safety had passed review.
The company plans to resubmit its application following the resolution of manufacturing compliance problems at the third-party facility and expects FDA approval within six months of this submission according to Nguyen’s press release.
Atara partners with Pierre Fabre Laboratories to gain approval for Ebvallo as a treatment for EBV+PTLD patients who have tried at least one previous treatment method.
Europe granted tabelecleucel its first licensing approval in December 2022 making it the inaugural allogeneic cellular therapy licensed anywhere.

The treatment method differs from standard autologous cell therapies where the patient’s cells get used by sourcing modified cells from healthy individuals. Manufacturers expect this new method to solve production and distribution problems that prevented earlier cell therapies from reaching patients successfully despite its popularity.
Pierre Fabre reached an agreement with Atara in 2021 to commercialize Ebvallo across Europe and select territories outside Europe. A 2023 agreement enabled Pierre Fabre to manage all U.S. manufacturing and testing operations for Ebvallo under a $640 million contract.

Novo Nordisk Planning Huge $4.1B Plant in NC For Ozempic Production

Editorial Team — Wed, 26 Jun 2024 17:42:05 +0000

It seems like GLP-1 giants Novo Nordisk and Eli Lilly are locked in a fierce battle as they work towards scaling production to meet the sky-high demand for their obesity medications. The Danish pharmaceutical company Novo Nordisk said that it would spend $4.1 billion to build a second fill-finish factory at its large site in Clayton, North Carolina.

It has been one month since Lilly announced a $5.3 billion investment to enhance its production capacity, and now Novo has responded.

According to Novo, the location will have a floor area equivalent to the combined floor space of Novo’s three existing production facilities in the state—1.4 million square feet.

Novo will manufacture the blood sugar-regulating medication Ozempic for diabetes, along with Wegovy for obesity, at the new factory. This project is part of Novo’s anticipated $6.8 billion investment in manufacturing this year, an increase from nearly $4 billion in 2023.

Lars Fruergaard Jorgensen, CEO of Novo, remarked, “This is yet another real signal of our efforts to scale up our production to meet the growing global need for our life-changing medicines.”

As a result of the development, Novo intends to hire 1,000 additional employees, increasing their current workforce of 2,500 in the state. Additionally, Novo said the building project would result in the employment of up to 2,000 contractors. Work has already begun on clearing and laying the foundation. The various phases of construction will be completed between 2027 and 2029.

In March 2023, Novo created space for expansion by acquiring 104 acres next to its campus in Clayton for $6.8 million, without disclosing any building intentions at that time.

Novo is reportedly constructing the site to be environmentally friendly, with innovative water methods and a roof covered in solar panels.

Novo commenced operations in Clayton in 1993, and through numerous expansions, the company extended its initial factory on the site to a total area of 457,000 square feet. When it went online in 2021, the company’s second factory at the location was the biggest life science project ever undertaken in North Carolina, with a total cost of $2 billion. This factory was Novo’s first outside Denmark to create active pharmaceutical ingredients.

In 2022, the company expanded to a 180,000-square-foot facility in Durham, North Carolina, 40 miles northeast of Clayton. Its oral semaglutide product, Rybelsus, is developed there. Novo acquired the factory in 2019 from Purdue Pharma.

Novo has production facilities in Denmark, the U.S., China, Brazil, and France, and its manufacturing unit employs up to 20,000 people. The firm’s parent company, Novo Holdings, paid over $16 billion to acquire CDMO giant Catalent in an attempt to increase manufacturing capacity. As part of the transaction, Novo Nordisk will acquire three fill-finish facilities for $11 billion.

French Company Orano Med Opens New Radiation Production Facility Near Indianapolis

Editorial Team — Sat, 08 Jun 2024 22:37:41 +0000

In a nuclear medicine surge, industry leader Orano Med has selected the U.S. as a production site for further radiopharma development. Orano Med, which is developing tailor-made alpha therapies for cancer, has launched its first Alpha Therapy Laboratory (ATLab) near Indianapolis in Brownsburg, USA. This site represents the company’s first manufacturing facility for lead-212-based radioligand therapies on an industrial scale.

Radiopharmaceuticals are directed radioactive agents that function effectively for diagnosing diseases in small doses, while in higher doses, they are useful for curing cancers and other diseases. Unlike other market offerings such as Novartis’s Pluvicto and Lutathera, which employ beta-emitting isotopes, Orano Med utilizes the alpha-emitting isotope lead-212.

Historically, there have been two types of radiotherapies, and the global market has preferred beta particles because beta emitters were comparatively easier to obtain, according to Orano CEO Dodet in an email interview. However, using alpha particles, as Orano Med does, is expected to improve the efficiency of drug candidates.

Orano Med plans to invest $20 million in ATLab Indianapolis, which will cover 30,000 square feet and create 25 new positions within the company. This development follows Orano Med’s move to commence construction of a similar facility in Valenciennes, France, to cater to the European market.

Combined, these facilities will enable Orano Med to produce 10,000 radiopharma doses per year for global use by 2025. The company aims to achieve the production of 100,000 doses by 2030, as stated in a press release.

Orano Med’s CEO Dodet emphasized the importance of manufacturers developing radioligand therapies to carefully plan their manufacturing and supply schemes. Due to the short half-life of isotopes, radiotherapies must be manufactured ‘just in time’ to be administered to patients.

The demand for radiopharmaceuticals, including alpha emitters, continues to rise. Current manufacturing complexes often rely on isotope supplies from Cold War legacy stock or the U.S. Department of Energy, which cannot meet the growing demand, the CEO stressed.

The technology has received increasing attention, particularly from companies in the oncology sector. Novartis remains a leader in this field, having brought two FDA-approved radiotherapies to market. Recently, Novartis acquired Mariana Oncology for up to $1.75 billion, further highlighting its interest in the sector.

Gerresheimer Increases the Capabilities of Medical Systems in the USA

Editorial Team — Tue, 28 May 2024 11:05:10 +0000

Gerresheimer, the maker of innovative systems and solutions and a partner to the pharma, biotech, and cosmetics industries, is increasing the production capacity of medical devices like inhalers and autoinjectors in the United States. The second expansion phase involves increasing the production area at Gerresheimer’s site in Peachtree City, Georgia, USA, by about 18,000 m² (200,000 sq ft).

This phase costs a total of approximately 166 million euros (USD 180 million) for the construction and equipment for the new buildings.

Gerresheimer is an innovative system and solution provider and is considered the world’s leading supplier to the pharma, biotech, and cosmetics sectors. It provides a wide range of primary containment products and secondary containment systems for medicines, drug delivery systems, and medical equipment and devices required in the healthcare sector. The solutions span therapy-supporting technology, drug pumps, syringes, pens, auto-injectors and inhalers, injection vials, ampoules, tablet casings, infusion systems, droppers, and syrup bottles.

Today, Gerresheimer’s production is located in 35 sites across 16 countries in Europe, America, and Asia, and all its products are manufactured according to the specific markets. Currently, the company has about 12,000 employees, and its sales for the year 2023 reached nearly 2 billion euros. Gerresheimer AG is listed on the MDAX of the Frankfurt Stock Exchange.

More than 400 new full-time jobs will be generated by Gerresheimer in Peachtree City as a result of the expansion. To date, the company directly employs approximately 270 people at the location. The Peachtree expansion will also highlight Gerresheimer’s strategic market position as a system and solution partner for drug delivery systems in North America.

The first stage of the expansion involved the construction of a new building section which took up about 7,700 m² (83,000 sq ft) and formed a continuous line with the existing plant. The area designated for the ISO 14644-1 cleanroom class 9 production and manufacturing halls includes approximately 5,000 m² (53,800 sq ft). In the second half of 2024, the specific equipment and techniques needed for production will be set up once the construction is finished. From the given project, unfortunately, it is not clear what the new section of the building is, but by the end of 2024, production is expected to increase to full capacity. Additionally, part of the new building will include another high-bay warehouse equipped with the latest automated technology. At the end of the first stage of expansion, the Peachtree City site is expected to have 15,284 square meters of cleanroom class 8 and 9 production floors.
During the second phase of expansion of Gerresheimer’s production facilities in Peachtree City, a brand-new modern building totaling an area of 10,200 m² (110,000 sq ft) is being constructed near Atlanta Regional Airport, some 2.6 kilometers (1.6 miles) away. This will be the first production site that will include a further 7,200 m² (77,500 sq ft) of cleanroom class 9 production area and an automated high-bay warehouse. The site has been prepared for the construction of access roads and supplies for the new factory, and construction of the factory building is to start soon. In 2025, further assembly lines of production are planned to be installed, and production is also planned to begin in the second half of the year 2025. The new construction site is spacious enough to accommodate future expansion.

Gerresheimer manufactures medical equipment at its Peachtree facility, including autoinjectors, test cards for microbiological testing, inhalers, and parts for infusion systems. These devices can be used, among other things, in the treatment of diabetes and obesity.

Novo Nordisk invests $560 million to increase Chinese medicine production

Editorial Team — Fri, 22 Mar 2024 18:18:39 +0000

Novo Nordisk, a prominent player in the pharmaceutical industry, is commemorating three decades of operations in China, coinciding with the potential approval of its highly coveted weight loss injection, Wegovy, in the Chinese market. This milestone is significant given China’s escalating rates of obesity and diabetes, making it a pivotal market for Novo Nordisk’s innovative pharmaceuticals.
In a bid to fortify its position, Novo Nordisk is channeling around 4 billion yuan, approximately $556 million, into expanding its Tianjin facility, which has been operational since 1994. This expansion primarily focuses on enhancing sterile preparation capabilities and is scheduled for completion by 2027, aiming to cater to the escalating demand for advanced medications among Chinese patients.

The decision to ramp up manufacturing capacity in China aligns seamlessly with Novo Nordisk’s strategic objectives, especially in anticipation of Wegovy’s impending approval in the country later this year. As highlighted by Christine Zhou Xiaoping, Novo’s China business head, the product launch will initially target self-paying patients.
Novo Nordisk’s longstanding presence in Tianjin traces back to 1994, and recent investments mirror the surge in demand for its diabetes and weight loss therapies. In early 2023, the company earmarked 1.18 billion yuan ($164 million) to expand its finished product workshop and introduce a production line dedicated to pre-filled injection pens.
The latest undertaking by Novo Nordisk integrates cutting-edge isolator technology to streamline the production process for sterile drugs. Besides Tianjin, the company also houses a research and development hub in Beijing, showcasing its unwavering commitment to fostering innovation and advancing healthcare solutions in China.

This investment in China is integral to Novo Nordisk’s broader strategy for global manufacturing expansion. In addition to the substantial investment in Denmark’s production campus, the company announced significant expansion plans in France and made headlines with its acquisition of Catalent for a staggering $16.5 billion. This acquisition encompasses Catalent’s fill-finish plants across Italy, Belgium, and the U.S., signaling Novo Nordisk’s proactive stance in bolstering its manufacturing capabilities on a global scale.