Susan Haigney

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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued recommendations through the 

Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

 for securing the supply of anti-D immunoglobulins used to prevent RhD immunization during pregnancy in the European Union. The supply is in trouble because the number of plasma donors has declined. Donors with anti-D immunoglobulins are the only source for manufacturing these drugs, according to EMA, and these treatments are the only option to prevent RhD immunization during pregnancy.

Supply of anti-D immunoglobulins used to prevent RhD immunization during pregnancy is at risk in the EU. The number of immunized donors is limited and there is a decline in existing donors.

EMA’s drug shortages steering group recommends EU Member States to create plans to secure the supply of anti-D immunoglobulins in the EU that include safety, legal, ethical, and regulatory considerations.

Industry is encouraged to invest in manufacturing capacity and development of alternatives to plasma-derived anti-D immunoglobulins.

PhD immunization occurs, according to EMA, when a pregnant person with RhD-negative blood is exposed to RhD-positive blood from the fetus growing in their body. A potentially fatal immune reaction may result from the exposure and impact the health of the fetus as well as after the baby is born (1).

During their assessment, MMSG identified the following key vulnerabilities in the supply chain (2):

The number of immunized donors was limited and there was a decline in existing donors.

There were challenges in the collection, manufacturing, and pooling of small plasma batches.

Global capacity was constrained by a limited number of marketing authorization holders and centers collecting plasma for anti-D immunoglobulins.

There was a dependency on countries outside of the EU for supply of plasma for these products.

Recommendations for regulators, industry, and other stakeholders

MMSG issued recommendations to national regulators, the European Commission, the plasma industry, and research organizations. The new recommendations are for EU Member States to create plans to secure the supply of anti-D immunoglobulins in the EU that include safety, legal, ethical, and regulatory considerations. Reducing unnecessary use through procedures such as non-invasive prenatal screening should be focused on. Alternative treatments should also be researched and developed. Communication campaigns about plasma-derived medicinal products should also be implemented.

The recommendations also state, “Member States, in collaboration with experts, including learned societies, patient organizations, and other relevant stakeholders should develop national guidelines to facilitate prioritization of patients who require these medicines during shortage situations, where necessary. The MSSG may coordinate the development of a Union level prioritization plan to manage critical shortages, coordinated at Union level” (2).

EMA stated in the press release that the EC should identify measures to ensure the supply of these treatments and coordinate with EU Member States (1). “Policy measures set out in the proposed Critical Medicines Act could be leveraged, such as joint procurement of manufacturing services to establish or increase supply of these medicines to the EU,” the agency stated in the release. The recommendations document says the EC should also “facilitate cooperation between key stakeholders, including national competent blood authorities and national competent medicines authorities to ensure coherence across relevant legislative frameworks.”

Industry is also being encouraged to ensure the supply of these treatments in Europe by investing in manufacturing capacity and development of alternatives to plasma-derived anti-D immunoglobulins.

The recommendations (2) state that the plasma industry and research organizations should “collaborate with Member States and the European Commission to identify effective mechanisms to support plasma collection and use. Consider initiatives and tools implemented by regulatory authorities to secure the supply of anti-D immunoglobulins and where needed, provide relevant data necessary for identifying and developing these mechanisms.”

EMA. Strengthening Supply Chain of Anti-D Immunoglobulins. Press Release. July 4, 2025. 

https://www.ema.europa.eu/en/news/strengthening-supply-chain-anti-d-immunoglobulins

EMA. Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products to Address Anti-D Immunoglobulin Supply Chain Vulnerabilities. EMA/135603/2025. June 23, 2025. 

https://www.ema.europa.eu/en/documents/other/recommendations-executive-steering-group-shortages-safety-medicinal-products-address-anti-d-immunoglobulin-supply-chain-vulnerabilities_en.pdf

Articles

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

EMA Moves to Secure Supply of Critical Drugs Used During Pregnancy

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FDA announced on June 27, 2025, that Sandoz, Inc. is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial after customers complained that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection vials (1). While the company states it has not received any reports of adverse events associated with the recall, they did receive one complaint of the wrong product being given to a patient.

Four vials of penicillin G potassium for injection, USP were wrongly included in a lot of cefazolin for Injection, USP.

The two antibiotics have different indications. Using penicillin G potassium for injection, USP instead of cefazolin for injection, USP could be life threatening.

Sandoz’s new facility in Slovenia will produce injectable products for both existing and upcoming biosimilars.

The new facility is part of a $1.1 billion investment the company has planned through 2029.

The impacted lot number is PG4360, vial national drug code (NDC) number 0781-3451-70, with an expiration date of 2027-NOV (1). The lot was manufactured by Sandoz GmbH and distributed by Sandoz Inc. The vials that were incorrectly included have the vial NDC 0781-6136-94 and an expiration date of 2027-NOV.

The two antibiotics have different indications

Cefazolin for injection USP is indicated for the treatment and/or prevention of bacterial infections in different parts of the body in adults, the elderly, and children (1). Penicillin G potassium for injection treats certain serious infections, such as septicemia, skin infections, and wound infections, and can be used to treat diphtheria, community-acquired pneumonia, peritonitis, meningitis/brain abscesses, osteomyelitis, infections of the genital tract, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetes, actinomycosis, complications in gonorrhea and syphilis, and Lyme. It should be used to only treat or prevent infections caused by susceptible bacteria to reduce the chance of drug-resistant bacterial from developing.

According to an FDA press release (1), the two antibiotics have different indications despite being part of the same beta-lactam group of antibiotics and having overlapping patient populations. The dosing regimens for each may also differ.

Administration of penicillin G potassium injection instead of cefazolin injection may have life-threatening consequences that include lack of efficacy resulting in less than optimal treatment of severe infections, antibiotic resistance, allergic reactions, drug interactions, and cardiac arrhythmias caused by high potassium.

Sandoz is asking customers to return the recalled product, which was shipped to select wholesalers for nationwide distribution. The company recommends providers stop using the product immediately. Adverse events may be reported to FDA through its 

In other Sandoz news, the company broke ground on a new facility in Slovenia in July that will produce injectable products for both existing and upcoming biosimilars. The project adds $440 million to a $1.1 billion investment the company has planned through 2029.

"Biosimilars is the fastest-growing segment of our pipeline as the need of patients and healthcare systems for these critical medicines continues to grow rapidly,” Richard Saynor, chief executive officer of Sandoz, said in a press release (2). “As the global leader in the field, we are investing to meet rapidly growing patient demand. With a commitment of over US$1.1 billion, we are proud to significantly expand our biosimilar manufacturing capacity in Europe as Slovenia’s largest direct foreign investor. This is another major step that will position Sandoz uniquely to capitalize on the unprecedented biosimilars market opportunity of the next decade."

"Our investment in biomanufacturing in the heart of Europe marks another important milestone in building our own independent manufacturing network—one that enhances our control, resilience and agility across the global supply chain,” Glenn Gerecke, chief manufacturing and supply officer at Sandoz, said in the release. “We recognize the strategic value Slovenia brings for us as a company: a highly skilled talent pool in natural sciences and engineering; a central location with world-class logistics infrastructure; cost-competitive production; and a stable, innovation-driven environment closely connected to academia and research."

FDA. Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging. Press Release. June 27, 2025. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging

Sandoz. Sandoz Further Asserts Leadership in Biosimilars, Breaking Ground on New Slovenia Facility to Expand European Biosimilar Hub and Global Market Reach. Press Release. July 1, 2025. 

https://www.sandoz.com/sandoz-further-asserts-leadership-biosimilars-breaking-ground-new-slovenia-facility-expand-european/

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Hikma Pharmaceuticals USA announced on June 28, 2025 that it is investing $1 billion by 2030 to expand its generic-drug R&D and manufacturing capabilities in its Ohio and New Jersey, United States, facilities. The company has invested $4 billion in the past 15 years to expand its US operations, which began in 1991, and now has an annual domestic capacity to produce 12 billion finished doses of generic medicines.

"We are proud to continue our ongoing investments in US manufacturing and R&D to better serve the needs of American patients," Hafrun Fridriksdottir, president, Hikma Rx, said in a press release (1). "Hikma and our 2300 dedicated US people are committed to supporting healthier communities nationwide by providing Americans with a steady and reliable supply of domestically produced quality medicines.”

“Over the past 15 years Hikma has grown to become a top three US supplier of sterile injectable medicines with more than 180 injectable products in our portfolio and a growing pipeline,” Bill Larkins, president, Hikma Injectables, added. “This new phase of US investment will enhance and expand our sterile injectables production capabilities and enable us to continue providing our broad portfolio of essential medicines to US patients.”

Investment in affordability and community

“As a pharmacist and chairman of the American-Made Medicines Caucus, I understand the crucial role Hikma and other generic manufacturers play in delivering affordable and accessible medicines to Americans. It’s important that we onshore the production of these critical drugs. I will continue working with Hikma to strengthen our national security and public health by making life-saving generic medications here, in America, and applaud them for their announcement today,” US Rep. Buddy Carter, R-Ga., said in the release.

“Hikma continues to invest in American workers, and I am thrilled that they have chosen to continue that commitment here in Columbus. This development will support a critical industry and create more jobs for working families in central Ohio. Additional manufacturing capacity will increase Americans’ access to high-quality, affordable medicines. I am proud to join Hikma here today to support their mission and the Ohioans they employ. I look forward to returning to see the new facility once it is complete,” US Rep. Mike Carey, R-Ohio, said in the release.

In other company news, Hikma published its 2024 Sustainability Report, detailing the company’s approach to sustainability.

"Access to medicines remains at the heart of everything we do at Hikma," said Tim Brooks, the company’s vice-president of Sustainability, in a press release (2). "This sustainability report highlights our belief that providing high-quality medicines is not just our business—it's our responsibility to our people, customers, healthcare professionals, patients and the communities we serve around the world. This year, we have further reinforced access to medicine as the core of our sustainability strategy by leveraging our strong manufacturing presence and working with stakeholders across the healthcare ecosystem.

“This key objective is supported by our commitment to our people, our planet, and our suppliers. Additionally, we have introduced metrics for each of these areas to demonstrate our performance and ensure sustainability remains embedded throughout our corporate strategy,” Brooks added.

Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines

Hikma Publishes its 2024 Sustainability Report Reinforcing Commitment to Global Access to Medicines

Acting Responsibly. Hikma Sustainability Report 2024.

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

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Aenova, a contract development and manufacturing organization, announced on June 27, 2025 that it is expanding its sterile manufacturing facility in Latina, Italy with a new cold chain warehouse that will be connected to the existing facility. The new warehouse will support a wide range of cold chain products without the need for special adaptations for specific APIs or countries and will help the company provide end-to-end integrated supply chain solutions for temperature-sensitive pharmaceutical products.

The new warehouse will be 6500 cubic meters with a total capacity of 1300 pallet spaces.

The warehouse will maintain a controlled, continually monitored temperature range of 2–8 ºC.

An additional 100 pallet spaces will be dedicated to packing, shipping, and final product preparation.

The new warehouse will be 6500 cubic meters, have a total capacity of 1300 pallet spaces, and will maintain a controlled temperature range of 2–8 ºC that will be continuously monitored via a supervisory control and data acquisition system in compliance with current good manufacturing practices (CGMP). An additional area will accommodate 100 pallet spaces dedicated to packing, shipping, and final product preparation.

The warehouse will have the capability to precisely track the location and movement of pallets via a fully automated digital system. An Automated Guided Vehicle system will move goods between production and storage areas. All time-of-refrigerator data will be digitally recorded, and two independent refrigeration systems will ensure uninterrupted operations by backing each other up, therefore providing business continuity. Drug substances will be stored in a dedicated freezer, and state-of-the-art technologies will also enhance energy efficiency and sustainability.

“This expansion significantly enhances our biologics and sterile drug product offering,” Paolo Abbate, managing director at the Aenova site in Latina, said in a press release (1). “By integrating cold chain storage directly into our manufacturing site, we can now offer our customers secure and streamlined logistics; this is a real competitive advantage in terms of speed, reliability, and compliance.”

Construction on the new warehouse began in early 2025, and the company expects the facility to be operational in the first quarter of 2026. An expansion of the Latina site’s fill/finish line for biologics is also planned for the future.

In other Aenova news, the company launched its Aenovation program for the acceleration of drug development in May 2025 (2). The program is designed to fast-track early development of drug formulations, especially to combat bioavailability and solubility challenges. The program deploys a science-based rational selection of formulation and technology and approaches pre-formulation and development in the following three steps:

API profiling and developability classification is done through assessment and testing of the API to determine solubility, permeability, solid-state properties, and powder physical characterization.

The formulation and prototype selection phase uses an API-sparing screening program that uses solubility enhancement technologies and includes process simulation, analytical characterization, accelerated stability assessment programs, and the supply of prototypes for pre-clinical studies.

Clinical-phase material manufacturing includes transfer to GMP lab- and pilot-scale environments, which involves validating analytical methods.

“Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimizing their resources,” Florent Bordet, chief scientific officer at Aenova, said at the time in a press release (2). “Our Aenovation program is a reflection of our commitment to innovation and excellence in pharmaceutical development.”

Aenova Expands Cold Chain Capabilities with New State-of-the-Art Warehouse at its Sterile Site in Latina

Aenova Launches Aenovation Program to Accelerate Pharmaceutical Development. 

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Ask the Expert: Adventitious Contamination Control

 video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.

To control adventitious contamination, variables that occur from operators, the environment, the process, and the process materials must be considered when dealing with extensive manipulation, Guidi says. “It's important to implement a combination of preventive measures, monitoring tools, and an efficient contamination control strategy. About the personnel, it should be noted that operators are the main source of bacterial and viral contamination. It would be a serious mistake to underestimate this factor, and I recommend investing a significant amount of time in training staff on aseptic procedures, adopting an open minded and non-judgmental approach. Cleaning and maintenance operators should also be approached in the same way so that they acquire the necessary awareness to mitigate the risk of advantageous contamination that they themselves could carry.”

Click the video above to watch Simona answer the following questions:

“My company is looking to control adventitious contamination for cell processing requiring extensive manipulation. What are some of our options?”

“My company is moving to a closed processing system for cell therapy production. How can we protect the product and the operator?”

Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma

. Simona has over 25 years of experience in Quality & Compliance and CMC for biological products and advanced therapy medicinal products (ATMPs), including cell and gene therapies. She has extensive expertise in assessing GMP compliance during the early stages of ATMP development.

Ms. Guidi has supported multiple ATMP facility teams in securing their first manufacturing authorizations for somatic cell therapy, gene therapy, and tissue-engineered products, both in EU and non-EU countries, for clinical and commercial use.

Throughout her career, she has collaborated with design teams of ATMP manufacturing facilities to evaluate compliance with EU and US GMP standards. She has also played a key role in remediation efforts following EMA and FDA inspections, helping sites achieve GMP and GMO compliance.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.

On June 24, 2025, Cambridge Healthcare Innovations (CHI), a start-up developing inhaler technology, announced that its dry powder inhaler (DPI) engine, Quattrii, is the first of its kind to deliver large volumes of biologic molecules and messenger RNA in a single inhalation (1). The DPI will be available for use by pharmaceutical companies in the fourth quarter of 2025.

Designed to deliver medicines to treat diseases that impact the lungs and airways and systemic conditions for which delivery to the lung may be preferable, Quattrii delivers at least 70% of the drug in one inhalation, according to CHI (1). In comparison, existing inhalers usually deliver between 10% and 50% of a drug to the lung. The drug is typically a small fraction of the formulation in DPIs, with the rest of the ingredients including things like lactose to make the drug easy to handle and fill. However, according to CHI, the extra powder may land in the patient’s mouth and throat, which may be unpleasant.

Quattrii separates the active ingredient from the lactose and retains the lactose fraction within the blister, resulting is less total powder inhaled by the patient and more active ingredient delivered to the lungs in one inhalation (1). The DPI engine supports payloads of between 30 mg and 100 mg and is designed around blister primary packaging, which may benefit biologics sensitive to moisture.

According to CHI, this unique design allows the DPI to be used to deliver novel lung cancer therapies (1). “CHI’s DPI engine would enable patients who are eligible to inhale their treatment directly to the lungs. The benefit of this inhalation technology—in place of traditional intravenous chemotherapy and/or immunotherapy—is the reduced amount the patient must receive to get the required therapeutic effect, and the avoidance of typical side effects such as hair loss and nausea. This also means that patients can receive their dose within a few seconds, rather than over several hours,” the company stated in a press release (1). The consistency of the delivered dose is typically achieved at a level that exceeds current regulatory requirements of +/- 25% of label claim. Therefore, novel therapies may have a better chance of passing a clinical trial.

“There is considerable worldwide research effort going into novel inhalable biologics and other large molecules; however, existing inhaler technology is just not designed to meet the challenges of delivering these potential blockbuster drugs to patients,” Jenny Lam, associate professor of Pharmaceutics at UCL and inhaled biologics expert, said in the press release (1). “CHI’s Quattrii DPI is truly unique and offers huge potential for those developing a wide range of drugs that can save the lives of millions of people.”

“The respiratory delivery route offers so many advantages for the patient,” 

, professor of Respiratory Medicine and clinical director of Respiratory Trials at Imperial College Respiratory Research Unit, said in the release (1). “Some of the new low-potency molecules under development will require inhaler technology that is more precise, more effective, and capable of delivering higher doses. I’m excited by CHI’s Quattrii inhaler platform as it addresses these issues and helps to open up the future of respiratory medicine.”

“Respirable drugs offer so much potential, but for too long the lack of innovation in inhaler technology has been a hugely limiting factor,” CEO and Founder of CHI, 

, said in the release. “They are either not capable of offering sufficient moisture protection, or of delivering the amount of drug a patient needs in one go, regardless of the vast range of lung and inhalation capacities. There is a better way—and by creating an inhaler from the ground up, that is designed to make the best use of the patient’s inhalation energy, we have been able to achieve something that is easier to use and provides much greater efficiency.”

Commercializing agreement with Aptar Pharma

In November 2024, CHI entered into an agreement with Aptar Pharma to commercialize the Quattrii DPI platform (2). As part of the agreement, Aptar will provide support and serve as a primary point of contact for customers.

“The CHI team brings deep knowledge, experience and innovation to the dry powder inhaler landscape,” Howard Burnett, vice president, Global Pulmonary Category, Aptar Pharma, stated in the November press release (2). “Aptar Pharma is very pleased to offer the Quattrii technology in partnership with CHI’s expertise. This enables us to provide full support from our portfolio of services to all drug developers, from formulation development to patient onboarding.”

First of Its Kind Inhaler for Conditions Beyond Asthma and COPD to Reshape Respiratory Drug Delivery.

Aptar Pharma Enters into Exclusive Agreement with Cambridge Healthcare Innovations to Commercialize the Quattrii Dry Powder Inhaler Platform.

Cambridge Healthcare Innovations says its dry powder inhaler engine, Quattrii, can deliver large volumes of biologic and mRNA molecules in a single inhalation. 