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

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com

Sun Pharmaceutical Industries (Sun Pharma), a Mumbai-based specialty generics company, has announced an agreement to acquire Checkpoint Therapeutics, of Waltham, Mass., a company that focuses on immunotherapy and targeted oncology (1). The two parties publicly disclosed the agreement in a jointly written press release on March 9 and 10, 2025.

The transaction, which is expected to be completed in the second quarter of 2025, specifies that Sun Pharma will acquire all outstanding shares of Checkpoint, whose stockholders will receive upfront, interest-free cash payments equivalent to $4.10 per share (1).

Included in the acquisition is Checkpoint’s cosibelimab-ipdl treatment, Unloxcyt, a programmed death ligand-1 (PD-L1)-blocking antibody that was approved by FDA in December 2024 for treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative procedures such as surgery or radiation (1,2).

“Combining Unloxcyt, an FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma, with Sun Pharma’s global presence, means patients with cSCC may soon have access to an important, new treatment option,” Dilip Shanghvi, chairman and managing director of Sun Pharma, said in the press release (1). “The acquisition further bolsters our innovative portfolio in onco-derm therapy.”

The performance of cosibelimab will be a factor in additional payments current Checkpoint stockholders may receive, according to the terms of the acquisition; if it is approved prior to certain deadlines in the European Union pursuant to EU’s centralized approval procedure, or in France, Germany, Italy, Spain, or the United Kingdom, a non-transferable contingent value right will activate, entitling the stockholder to up to an additional $0.70 in cash without interest (1).

Additionally, Checkpoint’s controlling stockholder, Fortress Biotech, has entered into a royalty agreement with Checkpoint and Sun Pharma whereas Fortress may receive future royalty payments based on sales of cosibelimab (1).

“I am proud of the dedication and passion of our team at Checkpoint that allowed us to achieve the first and only FDA-approved anti-PD-L1 treatment for patients with advanced cSCC, and we are excited to enter this transaction with Sun Pharma as the next step to bringing Unloxcyt to cSCC patients in need of a differentiated immunotherapy treatment option,” said James Oliviero, president and chief executive officer of Checkpoint, in the press release. “Sun Pharma is aligned with Checkpoint’s commitment to improving the lives of skin cancer patients, and I believe this transaction will maximize value for our stockholders and provide accelerated access to Unloxcyt in the United States, Europe, and other markets worldwide.”

Both PL-D1 and programmed death receptor-1 (PD-1) inhibitors were mentioned in the UK Medicines and Healthcare products Regulatory Agency (MHRA)’s 

marketing authorization for Johnson & Johnson’s Balversa (erdafitinib),

 in November 2024, as a monotherapy in treating adults with unresectable or metastatic urothelial carcinoma, particularly those patients harboring susceptible fibroblast growth factor receptor 3 genetic alterations and who previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (3).

Another treatment for squamous cell carcinomas, meanwhile, 

 from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), Coherus Biosciences’ Loqtorzi (toripalimab), for nasopharyngeal and esophageal SCCs (4).

1. Sun Pharma. Sun Pharma to Acquire Checkpoint Therapeutics. Press Release. March 10, 2025.
2. FDA. FDA Approves cosibelimab-ipdl for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma. Press Release. Dec. 13, 2024.
3. MHRA. Electronic Medicines Compendium, Balversa Summary of Product Characteristics. 

 (accessed November 6, 2024).
4. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.

Articles

The transaction includes Unloxcyt (cosibelimab-ipdl), which was approved by FDA in December 2024 for treatment of adults with cutaneous squamous cell carcinoma (cSCC).

Sun Pharma Agrees to Acquire Checkpoint Therapeutics

Feliza Mirasol is the science editor for 

Advances in manufacturing for new biotherapeutics and small-molecule pharmaceuticals are often based on current trends and/or changes or upgrades in equipment and processes. As biotherapeutic modalities grow more complex and as API dosing forms increasingly aim for high potency/low dose formats, equipment and process trends must keep pace. An exploration of current trends in equipment and processes can shed light on how these changes are supporting the way bioprocessing and pharmaceutical manufacturing is advancing going forward.

Starting early in the manufacturing lifecycle, the challenges associated with bioprocess development for a new biotherapeutic can fall into a few major categories. For one, in bioprocess development today, more than ever, there is a need for bioprocesses to be well aligned with the manufacturing supply chain and distribution strategy that is intended for that product right from the get-go, says Smriti Khera, PhD, global head of life sciences strategy and marketing at Rockwell Automation.

“If you look at the industry today, there are two parallel but opposing mega trends. One is that the manufacturing scales needed today are very different across various drug classes,” Khera says.

The bioprocess development for follow-on drug candidates, she emphasizes, “… willoptimize process to boost yield and productivity of the manufacturing process and that might require increased use of automation and evaluating new digital tools and technologies such as digital twins, PAT [process analytical technology] solutions, and beyond. An increased use of automation will produce efficiencies across the process, plant, and personnel needed to support the large scale manufacture of blockbuster drugs,” Khera says.

The more traditional challenges in bioprocess development are around determining and monitoring set points for critical process parameters (CPPs) and critical quality attributes (CQAs). “To do this, [bioprocess developers] need to perturb and evaluate the design space around a process and get a better understanding of the process overall, and that will help them ultimately put a better process and control strategy together,” Khera observes.

CPPs can be dramatically different at different scales, so maintaining conditions correctly, such as homogeneity, temperature, and dissolved oxygen, can be very different at different scales and must be monitored. “Determining the right conditions is [typically] a very labor-intensive process within bioprocess development,” notes Khera. “If you put that into context of today’s extremely diverse and massive therapeutic pipelines, it creates a resource constriction and massive demand for the process development experts’ time. That’s where a big opportunity exists today to leverage available data and science together through mechanistic and data-driven machine learning (ML) models and be able to run process simulations to help cut down on the manual experiments and expensive pilot runs needed.”

In terms of key equipment, there are a variety of critical equipment applications in biotherapeutic manufacturing, including single-use bioreactors, cell culture equipment, viral vector production systems, purification systems, fill/finish equipment, and real-time analytics gathering, says Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (KEP).

Christopher emphasizes that one of the most prominent recent developments in the biomanufacturing space is the increased adoption of single-use technologies (SUTs). “Advances in disposable components and equipment in a range of applications can help to reduce contamination risks, streamline cleaning requirements, and enable faster changeovers,” he states.

Christopher points to tubing, specifically, which presents one of the critical applications for single-use systems. However, alternatives to traditional silicone tubing offer potential quality and cost optimization benefits that Christopher says can make a true impact on biopharmaceutical manufacturing operations. “Bioprocessors have the opportunity to evaluate and source high-performing elastomeric tubing options that can help bring overall costs down without sacrificing quality or accuracy issues,” he states.

“Elsewhere,” Christopher adds, “we’re monitoring other evolutions, including continuous manufacturing systems, modular production units, integrated chromatography systems, advanced sensor and monitoring systems, and more.”

Meanwhile, automation has been playing a big role in advancing the equipment supporting bioprocessing. Christopher highlights digital twin technology, integrated control systems, automated sampling and analysis, and smart bioreactors as some of the automation developments being witnessed in the biomanufacturing space.

Automation is also being increasingly used at a commercial level. “From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” says Christopher. He interjects that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance. “But,” he qualifies, “full end-to-end automation is rare.”

On the small-molecule manufacturing front, the pharmaceutical industry is seeing a paradigm shift in processing equipment, driven by automation, sustainability, and regulatory compliance, says Caterina Funaro, Competence Center manager at IMA Active. Industry 4.0, for example, is accelerating the adoption of smart machinery, interconnected sensors, and artificial intelligence (AI)-driven control systems, which are enabling real-time monitoring and data-driven decision-making.

“Predictive maintenance is a key application where equipment can self-monitor for wear and tear and alert operators before a breakdown occurs, minimizing downtime. Smart factories are becoming a reality, where data collected from machines optimize operations in real time,” Funaro states.

Meanwhile, sustainability is a key focus in the pharmaceutical industry as manufacturers face pressure to adopt more energy-efficient equipment that reduces their environmental footprint, notes Funaro. “This includes reducing water and energy consumption, lowering emissions, and improving waste management. Recyclable and reusable components in machinery, as well as the use of environmentally friendly materials, are becoming more widespread,” she observes.

When it comes to developing a manufacturing process for new biotherapeutics, process engineers and, in general, drug developers can benefit from implementing automated technologies into the manufacturing process.

“As an automation engineer,” says John Hatzis, global life sciences industry consultant at Rockwell Automation, “I’m always thinking about tech transfer from process development into GMP [good manufacturing practice] manufacturing, and it’s important to use automation technologies that can make that transition easy.”

“It’s all about leveraging industry standards out-of-the-box so as to avoid the need to reprogram the system or retrain personnel when your therapy gets approved,” Hatzis explains. “If you adopt an automation platform that applies standards [such as] ISA-101 and ISA-88 earlier in your manufacturing, you can seamlessly transition your operations into GMP without costly retraining of personnel or re-architecting your automated systems. Having the features built into the platform that can be easily configured to comply with the regulations for data integrity when you need them is really important.”

For example, Hatzis points out, a developer that builds up a repertoire of automation software for a piece of equipment that does not have “off-the-shelf” features may need to undergo significant reworking when the time comes for tech transfer into a clinical manufacturing, where data integrity becomes crucially important. “All of these things are going to be really important to make tech transfer easy and efficient [going] into clinical or GMP manufacturing,” he states.

Nicolas Pivet, vice-president and general manager, Manufacturing Capacity & Digital Solutions, Cytiva, shares the company’s experience in working with partners to develop bioprocesses for new biotherapeutics. “What we’ve been experiencing is that many of our customers actually use a platform approach for process development, which is great for speed but sometimes is not optimized for everything,” he explains, noting that it was this gap between speed and optimization that prompted Cytiva to develop a software simulation tool (GoSilico). “[This tool] helps to characterize and optimize large sets of chromatography resins, for instance, and saves a lot of time,” says Pivet.

Pivet also brings up the automation layer, which is a layer that allows equipment information to be viewed together. “Over the past seven years,” he explains, “we’ve been developing [an] automation offering (Figurate), which is a wide range of automation solution and libraries—from historian to control systems with Unicorn [control software] to SCADA [supervisory conrol and data acquisition] with Wonderware [automation platform] and to distributed control systems [e.g., DeltaV, PlantPax].”

Developing an automation library for cell culture and purification steps and improving control over CPPs such as pH, oxygen, and temperature, enables parallel processing, which can ease scale-up from lab to production, Pivet explains. Meanwhile, applying automation to downstream chromatography and filtration steps helps optimize product purification, improving purity and yield.

The improvement in process PAT has also been key in the implementation of automation in bioprocessing, Pivet notes. “Today, it’s really about outlier technologies that are used in the industry—[Raman] spectroscopy with chromatography and mass spectrometry [for example]—to monitor product quality, but those solutions have been quite cumbersome on the [manufacturing] floor, so we are working on new and breakthrough technologies [as well as] simulation[s] to avoid the burden of physical experiments,” Pivet says.

Pivet also notes that in-silico process development tools are a game changer. For example, he discusses the development of a bioreactor scaler using computational fluid dynamics capabilities, which helps with scaling up or scaling down between processes. “We’ve shown that we can save up to 50% of the time to run characterization optimization studies, and we can also achieve up to five points higher yield. Truly, I think that automation benefits the whole workflow, the operations—from seed production … to [cell] harvesting and downstream processing, even fill/finish,” he explains.

Furthermore, PAT enhances monitoring at “moments of truth,” where critical control points impact drug quality, safety, and efficacy, Pivet also explains. Integration with manufacturing execution systems and laboratory information management systems ensures full process visibility.

Automation technologies, including PAT, are important now and will be crucial to the industry moving forward. “I think, in the area of process analytical technology, the industry needs to move faster. [Regarding] PAT sensors [for example], there’s the emergence of improved sensing technology. And measuring CQAs, for instance, in line or online is really the holy grail of the biopharma industry right now, so the industry needs to get there in being able to measure CQAs in line and helping with real-time release, or right-time release, of the drug,” Pivet states.

“At the end, we need a software orchestration to take all those sensor data, manage them in real-time, and, using artificial intelligence [AI]/ML modeling, drive a real closed-loop optimization of the batch to end up with a batch that’s prescriptive, where you can really intervene on the batch before it’s too late and maximize the outcome of the batch. So, that’s where the industry is going,” Pivet concludes.

Meanwhile, Christopher observes that, from the research his company’s team has performed and from what is being seen among the customer base, “fully automated commercial-scale biologics manufacturing is not yet common, but the industry is rapidly moving in that direction.”

He points to advances in robotics, AI, and ML accelerating progress. “But, plenty of challenges stand in the way, including cost of implementation, regulatory compliance, and more.We have heard from experts who anticipate that fully automated, ‘lights-out’ biomanufacturing facilities could become a reality within the next five to 10 years,” Christopher adds.

In small-molecule pharmaceuticals manufacturing, automated production lines minimize downtime, increase throughput, and enable continuous manufacturing. “Automated material handling, packaging, and processing reduce the need for human intervention, leading to faster cycle times. In continuous manufacturing—especially in pharmaceuticals and chemicals—automation enables uninterrupted processes, reducing the need for manual batch handling and improving scalability,” says Funaro.

“As automation becomes more advanced,” Funaro adds, “the workforce will need new skills in data analysis, robotics operation, and AI systems management. Upskilling employees to work alongside advanced automation systems will be critical.”

®
Vol. 49, No. 2
March 2025
Pages: 10–13

When referring to this article, please cite it as Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Industry 4.0 is driving adoption in the pharma industry for smart equipment 
and tools that will advance manufacturing.

Accelerating Adoption of Smart Tools to Advance Manufacturing 

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

FDA’s Center for Drug Evaluation and Research (CDER) Division of Drug Information said on March 10, 2025 that FDA has approved the first generics of rivaroxaban, in tablet form, to reduce risk of major cardiovascular events in adult patients with coronary artery disease, as well as major thrombotic vascular events in adults with peripheral artery disease (PAD), including those who recently underwent a lower extremity revascularization procedure due to symptomatic PAD (1).

Rivaroxaban is more commonly known by its brand name, Xarelto, manufactured by Johnson & Johnson Innovative Medicine, formerly Janssen Pharmaceuticals. It is an anticoagulant, the likes of which are among the most commonly prescribed medications in the United States, according to CDER (1).

 aims to address, among other objectives, both the challenges of developing generics and promoting more generic competition (1). The agency further said that first generics are a public health priority, and that it prioritizes reviews of applications for such products. In rivaroxaban’s case, CDER said the risk of major cardiovascular events—such as heart attack or stroke related to blood clots forming in the body, and traveling to the brain—is a serious concern, and that approval of the first generics for the drug will provide more treatment options to Americans reliant on anticoagulants.

Rivaroxaban has long been an option on the market to reduce risk of cardiovascular events such as stroke and blood clots. 

 Janssen recalled 13,500 bottles of Xarelto following a customer complaint of a microbial contaminant in a sales sample (2). The affected lots were traced to a facility in Gurabo, Puerto Rico, according to FDA at the time.

A generic form of rivaroxaban, Rivaroxaban Accord, was 

 by the European Medicines Agency (EMA) in September 2020, for treatment and prevention of venous thromboembolism, pulmonary embolism, and the prevention of atherothrombotic events (3).

In August 2023, the drug as manufactured by Janssen was 

 announced by the Centers for Medicare & Medicaid Services (CMS) whose prices would be directly negotiated with drug companies at the end of that month (4). Negotiations were to have occurred through the end of 2024, with negotiated prices coming effective at the beginning of 2026, according to CMS at the time. The other drugs listed were Eliquis (apixaban), Jardiance (empagliflozin), Januvia (sitagliptin), Farxiga (dapagliflozin), Entresto (sacubitril/valsartan), Enbrel (etanercept), Imbruvica (ibrutinib), Stelara (ustekinumab), and Fiasp and Novolog (insulin aspart) as well as various derivatives.

A Medication Guide will be dispensed along with generic rivaroxaban, according to CDER, which will list instructions on use and safety information (1). The drug already includes a boxed warning to healthcare providers about increased risk of thrombotic events. Additionally, CDER said, epidural or spinal hematomas may occur in those patients treated with rivaroxaban who are also receiving neuraxial anesthesia or undergoing a spinal puncture. In these cases, the agency said, the hematomas could result in long-term or permanent paralysis.

1. CDER Division of Drug Information. FDA Approves First Generics of Xarelto (rivaroxaban). Press Release. March 10, 2025.
2. Hernandez, R. 

Janssen Pulls 13,500 Bottles of Xarelto, Cites Contamination.

, Oct. 24, 2014.
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 14–17 September 2020. Press Release. Sept. 18, 2020.
4. Playter, G. 

White House Sets Medicare Price Negotiation Targets.

Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.

FDA Approves First Generics of Rivaroxaban Tablets

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

In an interview with Pharmaceutical Technology®, Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape. 

Industry Outlook 2025: Fostering the Development of Biotech in Europe

During 2024, many European countries held political elections, resulting in shifts in leadership. “First of all, the commission, the member states, and some of the programs have highlighted the commitment to biotechnology,” says Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics when commenting on how the political shifts may impact the bio/pharma industry. “Obviously, the evolving political landscape gets people worried about it, focused on that, and potentially leading to less attention to other aspects.”

Another potential outcome of a change in leadership for a member state may be their approach to deploying funding and support. “If we look at some more conservative approaches, they may be conducive to certain business perspectives but may be less conducive to certain other practices that would be important in terms of fostering the development of biotech in general, and cell and gene therapy in particular,” Forte explains.

Europe needs to be more competitive on the global platform within the field of biotech, Forte specifies, which has been recognized by relevant authorities across the region. “Take, for instance, [Europe’s stance] on cell and gene therapy, making it less of an exception and more of the mainstream, which I think is a recognition that [these therapies should be] part of our day to day,” he says.

However, it takes time for such changes to be fully realized and implemented, as various checks and balances need to be considered, Forte continues. “The key elements that to be to be considered [are] an investment in biotech and a recognition that we all need to work together to improve the competitiveness of Europe for the sake of the overall business, for the sake of the overall patient, and clearly, for the sake of us in Europe,” he summarizes.

Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

Videos

Almac Pharma Services, a part of Almac Group, officially opened a new, state-of-the-art, £65 million (US$84.2 million) commercial manufacturing facility in Craigavon, United Kingdom, on March 11, 2025 (1). The Northern Ireland site is also home to Almac’s global headquarters.

Construction of the facility was completed in late 2024, and, according to Almac, manufacture of good manufacturing practice batches will commence by March 18, 2025 pending successful completion of validation activities at the regulatory approved Center of Excellence (1).

Measuring 100,000 square feet, the facility enhances current capabilities, the company reported, in commercial oral dose treatment manufacturing in a variety of therapeutic areas, with high-specification production suites, an extension to current production scales of potent and highly potent drug products, and opportunities for partner companies to install custom technology or that which is dedicated to be tailored to those companies’ needs (1)

"We are thrilled to officially open our new commercial manufacturing facility at our global headquarters site," John McQuaid, president and managing director of Almac Pharma Services, said in a company press release (1). "This investment underscores our commitment to supporting our clients' growing needs with the highest level of service and expertise ... The new facility not only expands our range of capabilities but also reinforces our position as an industry leader in pharmaceutical development and commercial manufacturing with an ability to tailor our services to suit individual products. It also demonstrates our commitment to working in true partnership with our clients as we support them in bringing important new therapies to the patients we serve."

 about the challenges in providing services that face contract development and manufacturing organizations amid a growing pharmaceutical industry, higher demand for analytical services, and trends for future investment (2).

According to McQuaid, at that time, Almac’s plans for expansion were well on their way to taking shape.

“We're investing in cold chain capabilities, both for the clinical phases and the commercial phases, and then we have peptide synthesis coming online early next year [in 2025] at our API plant in Craigavon, with small molecule expansion kicking in later next year, and then further program for larger-scale API manufacturing,” he said in the CPHI Milan interview (2).

In January 2025, Almac announced a £500,000 (US$611,500 approximate) investment in state-of-the-art instrumentation for its spectroscopy laboratories at the Craigavon headquarters, namely a quadrupole-time-of-flight mass spectrometer (6545XT AdvanceBio Q-TOF, Agilent) and a diffractometer (Empyrean X-Ray Powder Diffractometer, Malvern Panalytical) (3).

That instrumentation investment came in addition to a previously announced £11 million (US$14.7 million) spend, made public in October 2024, intended to expand the company’s global analytical services capabilities and create 100 jobs, all of which followed an initial £250 million (US$324 million) commitment in capital investment, along with an intended workforce growth of 1800, made in 2022; that investment, according to Almac, has since increased to more than £400 million (US$518.5 million) (1,4).

View John McQuaid’s full interview with 

1. Almac Group. Almac Pharma Services Opens Doors on £65m New Commercial Manufacturing Facility. Press Release. March 11, 2025.
2. Thomas, F. CPHI Milan 2024: 

, Oct. 11, 2024.
3. Almac Sciences. Almac Invests £500,000 in State-of-the-Art Instrumentation Within Spectroscopy Laboratories. Press Release. Jan. 16, 2025.
4. Almac Group. Almac Group Announces £11m Investment to Expand Global Analytical Services. Press Release. Oct. 1, 2024.

The company’s 100,000-sq.-ft. space is expected to enhance its capabilities for commercial oral dose treatment manufacturing in a variety of therapeutic areas.

New Almac Pharma Services Commercial Manufacturing Facility Opens in Northern Ireland

Stäubli Robotics, a division of the global manufacturer Stäubli, is announcing one piece of its exhibit for INTERPHEX 2025, which will be held at the Javits Center in New York City from April 1–3, 2025. Sterimove, which the company describes as the first mobile robot designed for cleanrooms in the world, is scheduled to make its North American debut at the annual event (1).

According to Stäubli, whose North American headquarters are in Duncan, SC, Sterimove is engineered for Grade A/B/C/D cleanroom environments and meets highest industry standards for minimal contamination risk (1). The company said the robot offers numerous other advantages that improve compliance and ensure the safety of product and worker alike, including safety features such as sensors, collision avoidance systems, emergency stop buttons, and an LED status communication strip—plus easy access to wheels and resistance to vaporized hydrogen peroxide decontamination, to facilitate cleaning.

The robot, according to Stäubli, has a modular design, small footprint, and maneuverability in narrow spaces. It has an encapsulated design that is free of retention areas, which, according to the company, means that all sensors and other critical components are housed within the body of the robot; this prevents the ingress of contaminants and allows for resistance to rigorous cleaning and chemical disinfection (1). Taken together, the design features are intended to bring efficiency and productivity gains other sectors have experienced with mobile robotics into the pharmaceutical industry and enable manufacturers to optimize material flows.

“Sterimove exemplifies our commitment to innovation and excellence in automation technology for the pharmaceutical industry,” Rudolf M. Weiss, global head of Life Sciences & Food at Stäubli Robotics, said in the press release (1). “We are excited to showcase this groundbreaking technology at INTERPHEX 2025.”

®, Irina Rau, regional sales manager for Stäubli Robotics, explained that one driver for new technologies in robotics development is better compliance with European Union Good Manufacturing Practice Annex 1 (Manufacture of Sterile Medicinal Products) (2). This aligns with Stäubli’s disclosure that the Sterimove robot was designed following European Hygienic Engineering & Design Group guidelines as well as FDA compliance in mind, with the help of a Stäubli customer and “major player in the pharmaceutical industry,” according to the company (1).

Regarding specific technical elements, Rau also said new technologies also, among other advantages, can allow an operator outside an isolator to use a robotic arm to perform interventions inside the isolator without breaking the barrier. These technologies can provide an opportunity to avoid opening the isolator, thereby losing a batch of product (2). An inherent challenge is to design a robot’s movements to ensure ease of use for all operators—while keeping in mind flexibility, sensitivity, and safety of the process for both operators and the equipment itself.

In addition to its South Carolina headquarters, Stäubli North America has facilities in Novi, Michigan; Queretaro, Mexico; and sales personnel located on both the east and west coasts of the United States, serving the US (including Puerto Rico) and Canada (1).

Stäubli Robotics exhibited at INTERPHEX 2024 and will be at the event again in 2025, at Booth 3443 (1). You can find more of 

1. Stäubli. Stäubli Robotics to Unveil the World’s First Mobile Pharma Robot at INTERPHEX 2025. Press Release. Feb. 21, 2025.
2. Markarian, J. 

Sterimove will make its North American debut at the April 1–3, 2025 event.

Stäubli Robotics Previews World’s First Cleanroom Mobile Robot for INTERPHEX Display

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

According to Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, there are two aspects to consider when assessing the potential impact on industry of the new administration in the United States. “One is a conservative attitude to business, which I think might have some potential positive impact. That's good [because it] will support the economy and give a certain confidence to investment,” he says.

Additionally, Forte specifies that the leadership must impact business positively while also managing to make careful decisions around technological aspects of the industry, allowing organizations, such as FDA, the ability to perform their jobs. “I would also want to see that public health and product considerations are done the right way,” he adds.

A legislative change in the US that will more than likely have an impact on the bio/pharma industry is the introduction of the BIOSECURE Act, which was passed in September 2024. “I can understand some political motivations on how to manage the flow of the data [in relation to the BIOSECURE Act],” Forte says. “Some companies may get impacted, not only the ones that are directly targeted by the BIOSECURE Act, but also the ones that had deals and partnerships and collaborations with those companies, they will have to readjust their businesses again.”

Looking at industry regulations in more detail, Forte specifies that FDA has been keen on engaging in discussions about cell and gene therapy and becoming more comfortable with these novel modalities. “I believe that regulators [are] in a much better position today to make the right decisions and support the field in terms of the development [of cell and gene therapies], and that will translate in legislation, for sure, as well,” he adds. “I think, from a new technology point of view, we saw some good decisions in terms of reimbursement into the US recently, which I think is a good signal to the field.”

The Noramco Group, a Wilmington, Del.-based provider of products and services to the API and drug product supply chains, has announced a $25 million investment in the Whippany, NJ, facility of one of its subsidiaries, Halo Pharma (1). The purpose of the investment, The Noramco Group announced on March 10, 2025, is to establish sterile injectable manufacturing capabilities—namely ready-to-use syringe, cartridge, and vial filling—to address capacity shortages in the injectable supply chain in the United States that the company said are “critical.”

“This investment is a significant step in our commitment to build on our position as one of the only fully integrated domestic supply options for our customers,” said Lee Karras, CEO of The Noramco Group, in the company’s press release (1). “We recognize the challenges facing the industry and are dedicated to providing solutions that address both immediate and long-term supply chain needs. We anticipate the new line to be qualified and operational within the next 12 months, ensuring we can support customers with the high-quality capacity they require. While this investment enhances our capabilities with contemporary technologies, with the addition of sterile manufacturing we remain committed to our already established and proven focus on manufacturing APIs, oral solid dose, and liquid dosage forms, which continue to be essential in meeting our customers’ needs.”

Halo Pharma, a contract development and manufacturing organization, has focused on oral solid dose, semi-solid, and liquid formulation manufacturing for the past 20 years, but the Whippany facility will now undergo “significant renovations,” The Noramco Group said in the release, to maintain those primary production capabilities while adding a new sterile filling line (1). That installation will be done over the balance of 2025, upgrading the facility to meet European Union Annex 1 compliance for European market access, as well as maintaining US quality standards.

 examined the state of supply chains across the bio/pharmaceutical industry and how contract manufacturers are responding, 

 in the same vein as The Noramco Group’s March 10 release (2).

The announcement of the $25 million investment was made just days prior to the one-year anniversary of the launch of The Noramco Group, 

which Noramco announced on March 14, 2024

 as the umbrella term for its namesake API manufacturing business plus fellow subsidiaries Purisys, located in Athens, Ga., and Halo Pharma, which has operations not only in New Jersey but also Montreal (3). At that time, Noramco had only recently (in November 2023) acquired Halo Pharmaceuticals, which was actually the former name of Cambrex Drug Product Business Unit as of when the transaction was made (4).

The March 2025 news also comes one week before the start of the 2025 Drug, Chemical & Associated Technologies Association (DCAT) Week, to be held from March 17–20 in New York City (5). The Noramco Group said its executives will be on site to provide more information about the new sterile injectable manufacturing capabilities at the Halo Pharma site, and DCAT Member Companies are invited to interface with them during the event at the Intercontinental New York Barclay Hotel, suites 1007, 1141, and 1223.

 will be covering DCAT Week 2025 in depth, prior to, during, and after the event, and the landing page for all relevant content can be accessed 

1. The Noramco Group. The Noramco Group Invests $25 Million in Halo Pharma’s Whippany Facility to Offer Sterile Injectable Manufacturing. Press Release. March 10, 2025.
2. Lavery, P. 

Adopting Flexible Strategies to Combat Capacity Shortages.

, 49 (2).
2. Noramco. Noramco Announces Strategic Alignment with Purisys and Halo Pharma, Launching the Noramco Group as an Integrated North American-Based API and Drug Product Supply Chain Services Provider. Press Release. March 14, 2024.
3. Noramco. Noramco Announces the Acquisition of the Cambrex Drug Product Business Unit. Press Release. Nov. 2, 2023.
4. The Noramco Group. Noramco Group Announces $25 Million Sterile Injectable Manufacturing Investment at DCAT Week 2025. 

The investment is intended for the Halo Pharma facility in Whippany, NJ, and aims to help relieve capacity shortages in the injectable supply chain in the United States.

Noramco Group Establishes Sterile Injectable Manufacturing Capabilities with $25 Million Investment

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

research, doctor, microscope, experiment, dx, digital transformation, data, analysis, science, researcher, graph, chart, pharmaceutical, pharmacy, medicine, information, development, research institute | Image Credit: ©metamorworks - stock.adobe.com

The requirements for uniformity of dosage units using large sample size data collected and analyzed from process analytical technology (PAT) processes can be met by applying either 

) <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples or 

.) 2.9.47 Uniformity of Dosage Units Using Large Sample Sizes. However, both methods are designed to detect the number of dosage units falling outside the specification range of 75–125% of the label claim (% LC) to determine whether these numbers do not exceed the predetermined values based on the sample size.The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

) <905> Uniformity of Dosage Units (UDU; using small sample sizes) (1), the acceptance value (AV) limits are statistically adjusted (95% coverage) (2) and reintroduced in (3; Figure 1). However, a key weakness is that the AV result does not adequately describe the specific characteristics of UDU. To address this limitation, the application and use of tolerance intervals are extensively discussed in the article,“Using Tolerance Intervals to Assess Conformance to Requirements” (4).

To address the small gaps between the calculated tolerance intervals and specification ranges, the upper and lower tolerance limits (UTL and LTL) are set at 115% and 85% label claim (LC), respectively. The tolerance coverages above and below the mean are estimated and summed to obtain what is called “full tolerance coverage” (FTC), yielding a value close to 100%. Because the sample mean is directly used, larger sample sizes provide a more accurate batch mean estimate. Therefore, the FTC method is more practical and suitable for assessing UDU data in production batches, particularly those monitored through process analytical technology (PAT) instrumentation.

Pramote Cholayudth, cpramote2000@yahoo.com, is the founder and manager of PM Consult. He is an industrial pharmacist with more than 40 years of experience. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by Thailand’s FDA.

®
Vol. 49, No. 2
March 2025
Pages: 18-23

When referring to this article, please cite it as Cholayudth, P. Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes. 

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes

Pharmaceutical Technology® chats with Miguel Forte from ISCT and Kiji Therapeutics about expectations for 2025 and the future technology agenda for industry.

Industry Outlook 2025: Setting the Tone for Industry

One thing that Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, wants to see discussed in 2025 is the overall value proposition of drug products to patients. Companies should have a clear focus on manufacturing and optimization of technology to improve cost efficiency and improve access to patients, he asserts.

Looking at the potential technology agenda for industry in 2025, Forte remarks that the use of novel technologies is a key pressure point that will set the tone for industry as we move forward. “There's probably two elements,” he says. “One is the technical element itself: How do we manage and control and flow of information of those technical elements? And that's where we're going to see more closed systems, more automated systems, and more devices that can do things on their own. But then we need to control that in terms of information. That's where AI [artificial intelligence] will be particularly relevant.”

Additionally, from a technology agenda perspective, decentralized manufacturing will be important for industry in the future, Forte adds. “For the decentralization of the manufacturing, we need two things,” he continues. “We need devices that are able to be deployed closer to the patients, and information technology that is able to control those multiple devices. Because if you do decentralized manufacturing, you continue to have a single product that needs to be consistently released and have consistently the same characteristics across those multiple devices, and that requires flow of analytical data, flow of control in process, control data, and fine tuning that will require significant IT and adaptive IT, which is where AI comes in.”

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