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.

Industry Outlook 2025: Shifting Political Landscapes

After the results of the Presidential elections in the United States towards the end of 2024, there have been a lot of speculations about what impact the changing political landscape may have on many industries, including the bio/pharma industry. “The two big things that have happened in the US from a legislative point of view, the Inflation Reduction Act and BIOSECURE act, you know that they've blown a pretty cold wind through the industry,” says Adam Sherlock, CEO of Qinecsa, a pharmacovigilance technology and services solution provider. “So, one question is going to be, will [those things] continue to impact [the industry], and I suspect [they] will, because I don't sense that [they will] be rolled back. The biggest unknown, of course, is what's going to be the direction of travel of the incoming administration?”

It isn’t only the US that has undergone governmental shifts, however, as 2024 was also a key election year for Europe. “[In] Europe, we've got an increasingly aging but long living population,” Sherlock remarks. “So, I see the fundamental issue in Europe [as] downward price pressure […] on price, on industry, and at the same time medicine being required to deliver innovation and new therapies to treat longer living, older people with more complex needs, or just, in general, the population with more complex needs. How do you square those two things that that fundamental tension in the system doesn't change whether, you know, irrespective of the political hue of the of whichever government of whichever member state, we've got the same problem.”

Adam Sherlock is CEO of Qinecsa Solutions, which is a UK headquartered, international pharmacovigilance technology and services solution provider. Adam has more than 35 years’ experience within the pharma services industry and has held senior roles in a number of different pharma services businesses over the past 15 years.

Videos

Pharmaceutical Technology® sat down with Adam Sherlock, CEO of Qinecsa, to discuss the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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The glucagon-like peptide-1 receptor agonist (GLP-1 RA) Ozempic (semaglutide) has been approved by FDA for the reduction of risk of kidney disease worsening, kidney failure or end-stage kidney disease, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD), according to a press release from the drug’s maker Novo Nordisk on Jan. 28, 2025 (1).

"Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities. This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated," said Anna Windle, PhD, senior vice president Clinical Development, Medical & Regulatory Affairs at Novo Nordisk, in the release (1). "With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class."

The approval was based on results from a Phase IIIb trial (FLOW) that investigated the effects of the once-daily semaglutide injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD (1).

"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard E. Pratley, MD, medical director at the AdventHealth Diabetes Institute Orlando, Fl., and co-chair of the FLOW trial. "Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option."

FDA first approved Ozempic in 2017 to improve blood sugar, along with diet and exercise, in adults with type 2 diabetes (1). In June 2024, Ozempic’s increasing popularity as a weight loss prescription, due to semaglutides’ tendency to suppress appetite, led the World Health Organization to issue a medical product alert for three falsified batches (2).

 made mention of Ozempic alongside numerous other medications that encompass a large percentage of overall drug expenditure in the latest round of Medicare price negotiations (3).

This latest FDA approval for Ozempic follows the agency’s December 2024 approval of Hikma Pharmaceuticals’ liraglutide injection, making it the first generic version of Novo Nordisk’s Victoza (liraglutide injection), a GLP-1 receptor agonist, indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes, as an adjunct to diet and exercise (4).

1. Novo Nordisk. FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease. Press Release. Jan. 28, 2025.
2. WHO. WHO Issues Warning on Falsified Medicines Used for Diabetes Treatment and Weight Loss. Press Release. June 20, 2024.
3. Spivey, C. 

Behind the Headlines: Sana’s Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More.

, Jan. 27, 2025.
4. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.

Articles

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

FDA Approves Ozempic Indications for Reducing Risk of Kidney Failure, Cardiovascular Death

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The European Medicines Agency (EMA) announced on Jan. 29, 2025 that the European Shortages Monitoring Platform (ESMP) now has full functionality (1). ESMP was created so that marketing authorization holders (MAHs) and national competent authorities (NCAs) can directly report information about the supply, demand, and availability of authorized medicines, especially during crises situations. The information can then be used by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). EMA launched the platform in November 2024 (2) with core functionalities available at the time. On Feb. 2, 2025, use of ESMP becomes mandatory for MAHs and NCAs.

ESMP features monitoring and management of critical medicines during public health emergencies and is a requirement of EMA’s mandate to enhance monitoring of drug shortages and prepare for critical situations in the European Union and the European Economic Area (EU/EEA). The platform features harmonized reporting standards to enhance usability of data to allow the EU/EEA to quickly coordinate actions to mitigate drug shortages.

Training on the platform is available through webinars and information provided on EMA’s website. EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party provides additional information in its webpage (3). Information about drug shortages in the EU is available 

on EMA’s shortages catalogue and national shortages catalogues

“The release of the ESMP is a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most,” the agency stated in the November 2024 press release (2). “It will centralize and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the [EU and EEA].”

The industry often experiences drug shortages due to quality control issues, natural disasters, and periods of high demand. According to FDA in the United States, the leading causes of shortages are manufacturing quality issues, followed by delays in receiving materials from suppliers (5). Drug companies in the US have been required since 2012 to notify FDA about changes in product production of certain medicines to prevent shortages. And in 2024, FDA’s ability to identify and mitigate such shortages was enhanced by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which says that manufacturers must notify the agency of a permanent discontinuation of these crucial products, interruption of manufacture of these products, permanent discontinue of an API used in these products, and interruption of APIs used in these products (5).

EMA. European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU. Press Release. Jan. 29, 2025.

EMA. European Shortages Monitoring Platform Enables Better Monitoring of Shortages in the EU. Press Release. Nov. 28, 2024.

EMA. Medicine Shortages Single Point of Contact (SPOC) Working Party. 

https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party

EMA. Public Information on Medicine Shortages. 

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/public-information-medicine-shortages

FDA. Frequently Asked Questions about Drug Shortages. 

, Dec. 18, 2024 (accessed Jan. 29, 2025). 

https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

European Drug Shortage Monitoring Platform Fully Operational

Sustainability in Pharmaceutical Outsourcing

The pharmaceutical industry has a significant impact on the environment that includes CO

 emissions, water consumption, use of plastics, and a variety of manufacturing practices (1). Therefore, sustainability and green manufacturing are becoming priorities for the pharmaceutical industry due to evolving and changing regulations to protect both the environment and patients. 

spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers as they work with sponsors on the development and manufacture of drugs and biologics in a sustainable fashion that aligns with industry and regulatory requirements.

“Sponsors are increasingly requiring sustainable or green manufacturing practices when negotiating for partnerships with Neuland,” says Davuluri. “I think this trend is also kind of aligned with the broader industry shift towards sustainability … we are seeing that a lot of these companies are having their own approach on or their own frameworks in what they would like to measure their partners with. This is not just about Europe versus US, but also within a particular geography, every company has a different approach. Earlier, we used to see only big pharma or large generic companies having particular requirements. But now we're even seeing a lot of small to mid-sized biotechs talking to us and measuring us on our sustainability related practices as well.”

Click the video above to watch the interview.

1. Di Russo, M.; Zjalic, D.; Lombardi, G.S.; Perilli, A.; Congedo, G.; Daugbjerg, S.; Cadeddu, C. Impact of the 50 Biggest Pharma Companies: A Review of Environmental Report Aspiring to NetZero. 

https://doi.org/10.1093/eurpub/ckad160.1182

Saharsh Davuluri is Vice-Chairman and Managing Director, Neuland Laboratories. Saharsh is an electrical engineering graduate and obtained his master’s in management information systems from Weatherhead School of Management, Cleveland, Ohio, USA. He also secured Master of Business Administration from University of North Carolina, USA. He has worked in the past with Sify Limited in various roles in the Sales organization. He joined Neuland in 2007, with responsibility for initiating the Custom Manufacturing Solutions (CMS) business. He is currently responsible for all marketing, information technology (IT), and business development activities along with oversight of R&D.

Pharmaceutical Technology® spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers. 

Industry Outlook 2025: Through the Lens of a Service Provider

At the macro level, and through the lens of a service provider to R&D, there are three key trends that have impacted the bio/pharma industry over the course of 2024, according to Adam Sherlock, CEO of Qinecsa Solutions, a pharmacovigilance technology and services solution provider. “The three key things that I've seen this year are really an increased pressure on price and an increased scrutiny of the cost of health and the cost of health care provision globally; then we've had the kind of mega trend of AI [artificial intelligence]; then the third piece is actually, from a therapeutic point of view, has been the unbelievable success of the GLP-1 [glucagon-like peptide] class of products, and the potential implication for a much broader range of conditions, diseases, and treatment areas using GLP,” he says.

When looking at AI and the technology agenda for the industry in more detail, Sherlock believes there are two key areas that will be impacted. “The first is, what can AI/machine learning/robotic process automation/digitization do for efficiency and productivity? So, we see that as a service provider, we're looking to use these technologies to be more productive and more efficient, faster, and higher quality in terms of what we do for our clients, but we're also baking that into our own technology solutions that we are then selling to clients, and clients are using within their own businesses. So, the efficiency agenda, and that, of course, drives towards not just better productivity, but also, you know, lower cost. That's one key major theme that technology is enabling,” he says. “Then the other is, in the truest sense of AI, what innovative, new, generative output can be created by the industry using AI, whether that's around truly novel therapies, the use of data to find different patient cohorts, etc.?”

Adam Sherlock is CEO of Qinecsa Solutions, which is a UK-headquartered, international pharmacovigilance technology and services solution provider. Adam has more than 35 years’ experience within the pharma services industry and has held senior roles in a number of different pharma services businesses over the past 15 years.

Pharmaceutical Technology® spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

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

Lantheus Holdings, of Bedford, Mass., is acquiring the clinical-stage radiopharmaceutical contract development and manufacturing organization, Evergreen Theragnostics, Lantheus said in a press release on Jan. 28, 2025 (1). According to the release, Lantheus will pay $250 million up front in the all-cash purchase, but potential milestone payments, up to $752.5 million additionally, may be made in the future.

Lantheus said that adding Evergreen’s scalable manufacturing capabilities and infrastructure will allow Lantheus to meet the complex demands of radiopharmaceutical development and production (1). OCTEVY, a registrational-stage positron emission tomography agent for neuroendocrine tumors that Lantheus believes will complement its own therapeutic candidate PNT2003, is included in the purchase, along with certain other clinical and preclinical diagnostic pairs (1).

Executives on both sides of the transaction provided reaction and expressed optimism for the future.

“As Lantheus continues to advance its industry leadership, this transaction, along with the agreement to acquire Life Molecular Imaging, enhances our operations across the radiopharmaceutical value chain,” said Brian Markison, CEO of Lantheus, in his company’s press release. “With Evergreen’s manufacturing and development capabilities, we become fully integrated and will ultimately make a difference in the lives of more patients. We are pleased to welcome Evergreen’s talented team to Lantheus and are confident that their expertise in radiopharmaceutical theranostics and culture focused on developing new solutions for cancer patients will enrich our organization.”

As Markison referenced, in June 2024, Lantheus acquired an RM2—a small peptide that binds with high affinity to the the gastrin-releasing peptide receptor—originally developed by Bayer but licensed at the time to Life Molecular Imaging, for an upfront price of $35 million (2). That acquisition included Life Molecular’s novel, clinical-stage radiotherapeutic and radiodiagnostic pair 

Ga-DOTA-RM2, for the former of which a Phase I/IIa study in prostate cancer patients is beginning in 2025, with the latter used as a companion diagnostic.

Evergreen is headquartered in Springfield, NJ; its manufacturing facility there was constructed in 2020 (3).

“Today marks an exciting new chapter for Evergreen as we look to join the Lantheus team,” said Evergreen CEO James Cook, in the Lantheus press release. “Lantheus’ industry expertise and financial strength will help us bring our innovations to a broad patient population faster and support our mission to improve options for cancer patients through theranostic radiopharmaceuticals. We look forward to benefiting from Lantheus’ experience and resources to further advance our pipeline and continue developing cutting-edge therapies and diagnostics that have the potential to transform patient care. I am very pleased to have our Evergreen team join another industry-leading company with a shared vision.”

1. Lantheus. Lantheus to Acquire Evergreen Theragnostics for Upfront Payment of $250 Million to Drive Strategic Evolution into Fully Integrated Radiopharmaceutical Leader. Press Release. Jan. 28, 2025.
2. Lantheus. Lantheus Acquires Global Rights to Life Molecular Imaging’s Novel Therapeutic and Diagnostic Pair Targeting GRPR for Prostate and Breast Cancers. Press Release. June 27, 2024.
3. Evergreen Theragnostics. Evergreen Theragnostics Begins Construction of New Manufacturing Facility. Press Release. Sept. 23, 2020.

The deal is being made for an all-cash price of $250 million, but with an additional $752.5 million available in potential milestone payments.

Lantheus Announces Agreement to Acquire Evergreen Theragnostics

Johnson & Johnson company Janssen-Cilag International NV, based in Belgium, announced on Jan. 21, 2025 that the European Commission (EC) approved a marketing authorization for Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations (1).

This approval from the EC comes the same week that the National Institute for Health and Care Excellence gave positive recommendations for treatment of lung cancer patients in England and Wales to two AstraZeneca products, Imfinzi (durvalumab) and Tagrisso (osimertinib), the latter of which Antonio Passaro, MD, PhD, medical oncologist of the Division of Thoracic Oncology, European Institute of Oncology in Milan, Italy, referenced in a Johnson & Johnson press release (1,2).

A Phase III study (MARIPOSA) evaluated lazertinib in combination with amivantamab, in comparison to osimertinib as a first-line treatment (1).

“This chemotherapy-free regimen has already demonstrated significant progression-free survival improvements, and new topline data suggest it is expected to extend life by a median of one year or more, in patients with untreated EGFR-mutated NSCLC versus the current standard of care, osimertinib,” Passaro said (1). “These results mark a significant step forward in the treatment of EGFR-mutated NSCLC. Extending life expectancy is a critical indicator of a treatment’s impact. The MARIPOSA study reaffirms the potential of first-line treatment with this combination therapy to redefine the standard of care and offer clinically meaningful improvements in outcomes for patients.”

As Passaro mentioned, the Phase III study met its primary endpoint of progression-free survival, adding to Johnson & Johnson’s disclosure earlier in January 2025 that amivantamab plus lazertinib, according to topline overall survival results, met a final, pre-specified secondary endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant improvement in OS—the median length of which is expected to exceed one year—versus osimertinib monotherapy (1).

“Currently, the five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors is less than 20 percent,” Henar Hevia, PhD, senior director, Europe, Middle East and Africa therapeutic area lead, oncology, for Johnson & Johnson, said in the press release. “Today’s approval marks an important moment in lung cancer care, bringing a new option to patients through a chemotherapy-free regimen, and potentially offering more time with their loved ones.”

After presenting data from the Phase III study at the 2023 European Society of Medical Oncology Congress and the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer, Johnson & Johnson intends to detail the latest OS data at an upcoming medical meeting, which was not further specified in the release (1).

1. Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.
2. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

European Commission Approves Johnson & Johnson Non-Small Cell Lung Cancer Treatment

AstraZeneca has announced a C$820 million (US$570 million) investment in Canada, which the company says will create more than 700 high-skilled jobs across all areas of its business (1). In a press release on Jan. 23, 2025, AstraZeneca said the new jobs would be the result of a move to a larger, state-of-the-art office facility in Ontario, in the greater Toronto area (1).

This latest investment is part of AstraZeneca’s plan to bring 20 new medicines to patients—of which eight have been delivered to date—and achieve US$80 billion in total revenue by 2030, according to the press release. AstraZeneca also said it expects seven first Phase III clinical trial data readouts in the coming year (1).

“This investment is a reflection of our growing clinical pipeline, our strong belief in Canada’s potential as a global hub for life sciences innovation, and the value of public-private collaboration with the Ontario government,” Pascal Soriot, AstraZeneca CEO, said in the release. “We believe the diverse talent pool together with the network of world-class universities, hospitals, and research centers will help us bring new medicines to Canadians and patients worldwide.”

Ontario Premier Doug Ford mentioned that a government initiative has been made available to AstraZeneca for the purposes of this investment.

“Our government, through Invest Ontario, is proud to support AstraZeneca with C$16.1 million to help bring these hundreds of new, highly skilled jobs to Ontario, strengthening Ontario’s position as a global leader in life sciences and innovation,” Ford said in the release.

“AstraZeneca’s continued investment in Ontario is crucial to advancing innovative medicines that treat, prevent, and may one day cure complex diseases like prostate, lung, and breast cancer, as well as rare diseases,” Gaby Bourbara, president, AstraZeneca Canada, said in the release. “AstraZeneca’s investment of C$820 million (US$570m), alongside the Government of Ontario’s contribution through Invest Ontario, will strengthen the province’s life sciences strategy, driving economic growth, and foster innovation that benefits patients in Canada and around the world.”

What the high-skilled jobs are was not broken down in the press release, but among more than 200 global clinical studies currently being undertaken by AstraZeneca are those in the areas of breast, lung, and prostate cancers, chronic obstructive pulmonary disease, and severe asthma, according to the press release (1).

Earlier in January 2025, two AstraZeneca treatments, Imfinzi (durvalumab) and Tagrisso (osimertinib), received positive recommendations from the National Institute for Health and Care Excellence for lung cancer patients in England and Wales (2).

Since 2023, AstraZeneca’s investments in Canada have exceeded C$1.3 billion (approximately US$905 million), representing 1200 new high-skilled jobs (1). Currently, the company employs more than 2100 workers across Canada. In 2024, AstraZeneca reached an agreement to acquire Fusion Pharmaceuticals, of Hamilton, Ontario, which developed next-generation radioconjugates to be used in radiotherapy for cancer patients.

1. AstraZeneca. AstraZeneca Plans C$820 million (US$570m) Investment in Canada to Advance Growing Global Hub and Clinical Delivery. Press Release. Jan. 23, 2025.
2. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.

The company’s investments in Canada since 2023 have now resulted in the creation, or potential thereof, of 1200 new job positions.

AstraZeneca Makes Investment to Create 700 High-Skilled Jobs in Greater Toronto Area

Feliza Mirasol is the science editor for 

The winners of the 2025 Pharmapack Awards were announced on Jan. 22, 2025, according to Pharmapack Europe. The awards, which have been newly reformatted, recognize excellence in six key categories. In addition, this year’s awards used a new approach in which both commercialized products and groundbreaking innovations expected to shape pharma packaging's future were celebrated. For the first time, these awards were open to all participants in an effort to foster greater inclusivity and innovation, according to a press release (1).

The winners included many significant advancements, such as an autoinjector that eliminates the need for manual needle attachment, a fully recyclable and heat-sealable ultra-high barrier paper, and a multi-layered vial that is designed for storing gene therapy product. Other innovations included a prefilled syringe pack that reduces packaging waste by 62% and a non-electronic, eco-friendly label that can monitor both time and temperature. This year also saw the first “Women of the Year” commendations presented.

In the Delivery and Device Innovation category, the winner was Switzerland-based SHL Medical’s Elexy, a reusable electromechanical autoinjector, which was developed from years of innovative research. This autoinjector is drug-agnostic and has the widest range of primary container flexibility among autoinjectors, which means the device can caters to both prefilled syringe- and cartridge-based primary containers. The cartridge-based version of the autoinjector features SHL’s proprietary Needle Isolation Technology (NIT), which comprises a pre-installed needle housed within the cap of the autoinjector. This design eliminates the need for manual attachment of the needle and offers patients a more convenient device.

The winner of the Eco-Design category was Finland-based Huhtamaki’s fully recyclable, heat sealable, ultra-high barrier Omnilock Ultra Paper. This ultra paper is specially engineered to replace non-recyclable multi-layer laminates, including laminates made of paper, plastic, and aluminum. The product represents a significant innovation in sustainable packaging as it offers ultra-high barrier properties that were previously only found in non-recyclable multi-layer combinations of aluminum foil and plastic. Omnilock has a paper content ranging from 87–93% and is derived from FSC-certified fibers. The product maintains superior barrier performance while at the same time being environmentally friendly.

In the Packaging Innovation category, Japan-based Mitsubishi Gas Chemical (MGC) won for its new vial, the OXYCAPT Multilayer Plastic Vial, which is designed to store gene therapy products using dry ice and liquid nitrogen. Standard cyclic olefin polymer (COP) vials have a poor gas-barrier (2), making COP vials inadequate for drugs that are sensitive to oxygen (O

), according to the Pharmapack press release (1). The OXYCAPT consists of three layers: the drug contact layer, the outer layer (both made of COP), and the O

barrier layer, which is made an MGC novel polyester. OXYCAPT therefore provides an excellent O

, and ultraviolet (UV) barrier that is 20 times better than standard COP monolayer vials.

The Patient-Centric Design category winner was Belgium-based UCB Pharma’s redesigned BIMZELX 160mg autoinjector packaging, which consists of innovative features and takes a patient-focused approach. The redesigned packaging incorporates 15 new design elements and enhances the patient’s unboxing experience by prioritizing ease of use, sustainability, and functionality. Key design highlights include a “book style” carton construction that displays instructions better, an intuitive reclosing mechanism, a tamper-evident design, and a plastic tray consisting of 50% recycled polyethylene terephthalate material.

The winner in the Start-Up Innovation category was Italy-based Active Label for its non-electronic, environmentally friendly labels designed to monitor both time and temperature. These smart labels are activated with near-monochromatic UV light. They use engineered materials developed through research in collaboration with universities and research centers. Information from these labels is read using a compact reader that utilizes optically stimulated luminescence (OSL) and a proprietary algorithm that converts signals into time and temperature data. These data are stored in the cloud, which makes the data accessible remotely.

Pharmapack’s first inaugural Woman of the Year Award went to Asmita Khanolkar, senior director, Combination Products, Drug Delivery, Sterile Manufacturing, Device/Pharma Strategy and Commercialization, at US-based SMC Ltd. Khanolkar has more than two decades of experience, where she has managed and led various products from concept to commercial launch. Her product portfolio includes single-use, wearable and implantable devices, drug-device, device–biologic combination products for drug delivery, biotech, and biotherapeutics. The application of these products includes various indications such as diabetes, pain management, cell therapy, tissue regeneration, orthopedic, vascular, women’s health, oncology, surgical products, and more. She has made a significant contribution to advancing healthcare, having launched multiple medical devices and commissioning manufacturing lines for novel devices, including for first-in-human, single-use, on-body, and implantable cell therapy delivery devices.

“This year, we’ve seen a record number of award categories, yet the quality and innovation of entries continue to reach new heights. Notably, many submissions demonstrate a strong commitment to advancing sustainability through reduced raw material usage, improved recyclability, and lower carbon footprints, all while enhancing patient and user experiences,” said Tara Dougal, brand and content director—Pharma, at Informa, in the press release. “These efforts reflect the industry's determination to address critical challenges and shape the future of healthcare. We applaud the entire pharma packaging and drug delivery sector for its relentless drive toward innovation and transformative care standards.”

1. Pharmapack Europe. Pharmapack Award Winners 2025 Redefining Pharmaceutical Packaging and Drug Delivery. Press Release. Jan. 22, 2025.
2. Sarmadi, M.; Holmes, S.; Agha, R.; et al. A Comparative Study of Freeze-Drying Heat Transfer in Polymeric Vials and Glass Vials. 

Winners in this year's Pharmapack Awards include both commercial products and innovations that are shaping the future of pharmaceutical packaging. 

2025 Pharmapack Winners Showcase Innovations in Pharma Packaging and Drug Delivery

Provepharm announced on Jan. 24, 2025 that it has voluntarily recalled one lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) because a customer found a visible black particulate matter in a single-sealed vial. The recalled product is packaged in 10 mL, single-dose vials with national drug code 81284-213-01, lot number 24020027, and an expiration date of December 2025. It was distributed nationwide in the United States.

Phenylephrine hydrochloride Injection is used to treat hypotension resulting from vasodilation in the setting of anesthesia. Injecting product that contains particulates may cause local irritation and swelling.

“If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death,” the company stated in the press release (1).

The company advised wholesalers, distributors, compounders, and hospitals to immediately stop using the product and return it to Provepharm’s recall provider, Sedgwick. While the company states it has not yet received any reports of adverse events associated with the recall, these events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

Packaging problems, such as particulates and defective vials, are a common cause of product recalls. These recalls can be hazardous to the health of patients but can also be expensive for companies to resolve and prevent. In September 2024, Gilead recalled one lot of Veklury (remdesivir) for Injection 100 mg/vial after a customer complaint of a glass particle found in a vial. An investigation performed by the company confirmed the presence of the glass particulate. While at the time of the recall the company had not received reports of any adverse events associated with the recall, if administered, the glass particulate could travel to organs and blood vessels, causing stroke or death.

, Dirk Margosch, vice president visual inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, discussed steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (3). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences, according to Margosch.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

FDA. Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter. Press Release. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp

FDA. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle. Press Release. 

Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. 

https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

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