Susan Haigney

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

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. 

Articles

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. 

Quattrii Delivers Biologics and mRNA Molecules in Single Inhalation

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

On June 24, 2025, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that the 12

) will be released as an all-digital, redesigned, user-friendly platform that will allow users to stay connected with quality standards via a 365-day license (1).

EDQM will host a two-part webinar to present the benefits of the new platform. “Unlocking the Potential of the European Pharmacopoeia Online will be held on July 1, 2025 with another session to be presented on July 3. Module 1 will discuss new features, advanced navigation, and searching options. Module 2 will discuss license activation and user management. Information on how to register for the free webinars can be found on 

. License information for the new digital edition is also available at the site.

 provides legally binding standards from a legal and scientific basis for the quality control of drugs and drug ingredients in the European Union.These standards must be applied to marketed medicinal products in the EU.


In other EDQM news, the organization’s podcast EDQM on Air released an episode discussing the phase out of the rabbit pyrogen test (RPT). The RPT is a safety test used to determine if pyrogens are present in medicines. More than 400,000 rabbits are used worldwide, according to EDQM, to perform the test. EDQM has been promoting the use of alternative tests and removed the RPT in June 2024 from 

 texts. In the podcast, Gwenaël Cirefice and Emmanuelle Charton explain how EDQM is committed to animal welfare in Europe (2).

The limitation of animal testing has also been promoted in the United States. In July 2024, the United States Pharmacopeia (USP) announced it was permitting the use of non-animal-derived reagents for endotoxin testing (3).Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discussed the new USP chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, and how it will impact industry in the 

November 2024 episode of PharmTech’s Ask the Expert video series

“Twenty years ago, the predominant test procedure for determining endotoxin level, or pyrogen level, as we called it, was the rabbit test. And we used to actually inject rabbits, which was very subjective because you'd measure their temperature,” Schniepp said in the episode. “And then we evolved to using the limulus amoebocyte lysate or LAL test, and there was the chromogenic [test] but they were all predicated off the horseshoe crab. So now we're moving forward to reagents for this test, which is critical to the release of sterile injectables that does not involve animals. So absolutely, we should consider this.”

“I think it is also worthwhile mentioning that what is happening in the US is mirrored in other jurisdictions, for example, when you look at the European Medicines Agency [EMA], they support the use of animal free cell culture reagents as part of its efforts to reduce animal use in medicine testing,” Schmitt added. “We don't want to use rabbits. We don't want to use horseshoe crabs, and it's EMA’s innovation task force that encourages that use of alternative methods to animal models, and that, what they say is, will improve the scientific quality and also, of course, animal welfare.”

Nicola Reid, associate director of Product Management, Endotoxin Products at Charles River Laboratories, also 

provided her perspective on the USP chapter in an interview with 

® (5). “When [endotoxins] do end up in a final product, [and] when that [product] is injected or implanted into a patient, it can lead to what we call a pyrogenic response,” Reid explained. “What that means is the human body is reacting to this contaminant, and it can cause anything from a mild fever all the way through to death. That's the ultimate circumstance of too much endotoxin. So, therefore, most pharmaceutical products that are tested for endotoxin are those that are injectable or implantable and come into contact with the bloodstream, and therefore have to have low levels of endotoxin.”

EDQM. EDQM On Air–A Win for Animals–Phasing Out the Rabbit Pyrogen Test. Press Release. June 19, 2025.

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

Thomas, F. and Haigney, S. Non-Animal-Derived Reagents for Endotoxin Testing. 

https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing

Haigney, S. The Impact of USP Chapter <86> on Endotoxin Testing. 

https://www.pharmtech.com/view/the-impact-of-usp-chapter-86-on-endotoxin-testing

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue. 

European Pharmacopoeia Goes Digital

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 13 medicines for marketing authorization at its June 16–19 meeting (1). Among the authorized medicines are six biosimilars and two generic drugs. These approvals bring the total medicines approved for authorization in 2025 so far to 56.

Austedo (deutetrabenazine) was granted marketing authorization for the treatment of adults with moderate-to-severe tardive dyskinesia. Patients with tardive dyskinesia experience abnormal involuntary movements resulting from chronic or episodic exposure to dopamine receptor antagonists.

Positive opinion was given to Imreplys (sargramostim) for the treatment of hematopoietic acute radiation syndrome, when bone marrow does not produce enough blood cells, leading to infection and bleeding, after exposure to radiation. The authorization was given under exceptional circumstances, due to the rarity of the condition and lack of comprehensive data (2).

The orphan drug, Ogsiveo (nirogacestat), was approved for the treatment of adults with progressing desmoid tumors. These are soft tissue tumors that form in fibrous tissue in areas such as the abdomen, arms, and legs, but do not spread to other locations.

Zemcelpro (dorocubicel/unexpanded umbilical cord cells) was granted conditional marketing authorization for the treatment of adults with hematological malignancies (blood cell cancers). Zemcelpro is used to treat patients that require allogeneic hematopoietic stem cell transplantation following chemotherapy or radiotherapy when no other type of suitable donor cells is available.

EMA also granted conditional marketing authorization to Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH). MASH is a condition where fat cells accumulate in the liver and cause chronic inflammation. Currently, there are no authorized treatments for metabolic dysfunction-associated steatohepatitis in the European Union.

The following six biosimilars were given a positive opinion at the June meeting:

treatments for treatment of age-related macular degeneration and visual impairment: Mynzepli (aflibercept), and its duplicate Afiveg (aflibercept), Vgenfli (aflibercept), and its duplicate Eiyzey (aflibercept)

Usymro (ustekinumab) for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s Disease

Vivlipeg (pegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Two generic drugs were also approved. Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris (emtricitabine/rilpivirine/tenofovir alafenamide) was approved to treat adults and adolescents with HIV type 1. Nintedanib Viatris (nintedanib) was approved for the treatment of idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis associated with interstitial lung disease.

CHMP also extended indications for Benlysta, Cabometyx, Darzalex, Imbruvica, Nubeqa, and Sarclisa. The indication for use of Dapivirine Vaginal Ring 25 mg (dapivirine) outside of the EU and by women 16 years of age was also extended.

In addition, at the meeting, CHMP announced that it is re-examining its negative opinion on Atropine sulfate FGK (atropine), a medicine intended to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction in the range of -0.50 to ‑6.00 diopter. It is also re-examining its negative opinion on the Alzheimer’s disease drug, Kisunla (donanemab).

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16–19 June 2025. Press Release. June 20, 2025.

2. EMA. Exceptional Circumstances. Ema.europa.eu (accessed June 23, 2025). 

https://www.ema.europa.eu/en/glossary-terms/exceptional-circumstances

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Six Biosimilars Part of EMA’s Authorization Recommendations in June

BASF announced on June 17, 2025 that it has opened a good manufacturing practice (GMP) facility in Wyandotte, Mich. as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients to the biopharma and pharmaceutical industries. The facility expands on BASF’s existing network of GMP sites. BASF Pharma Solutions is a manufacturer of excipients and APIs.

The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. These will allow the company to customize chemistries for product development and provide more tightly controlled parameters beyond compendial limits and a validated control system, according to a press release (1).

“Our new GMP Solution Center exemplifies BASF’s dedication to understanding and addressing the evolving needs of our customers in both the biopharma and pharmaceutical industries,” Marion Kuhn, vice president of business management, BASF Pharma Solutions, said in the press release. “This state-of-the-art facility will play a fundamental role in enabling us to collaborate closely with our customers worldwide on product development and GMP manufacturing in ways that are unique to the industry, further strengthening our position as an innovator in the pharmaceutical sector.”

“Wyandotte’s new GMP Solution Center is a key example of BASF’s commitment to innovative excellence,” added Benjamin Knudsen, vice president of research North America at BASF Corporation. “This expansion not only showcases our dedication to developing customized solutions, but it also highlights our ability to adapt and innovate in response to our customer’s needs. Together, we are paving the way for new innovative solutions.”

The quality of pharmaceutical ingredients is imperative for ensuring a robust and safe drug supply chain. Poor-quality APIs that do not meet standards may destabilize drug formulations, creating quality control problems and regulatory actions that result in drug recalls (2).

“From a supply chain perspective, poor-quality APIs increase the likelihood of production interruptions, which disrupt the supply to the market,” Qixuan Lu, vice-president of Process Chemistry at BioDuro, said in an interview about API quality with 

® (2). “Because of the poor-quality API, additional quality control measures become necessary, driving up costs and diminishing profit margins. If such issues arise repeatedly, they can harm a company’s reputation and undermine market confidence in its products. Beyond these commercial setbacks, manufacturers also face considerable legal and regulatory risks if they fail to meet the standards required for pharmaceutical quality and patient safety.”

 video interview, experts discussed key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains (3).

BASF. BASF Strengthens Its Commitment to the Biopharma and Pharmaceutical Ingredients Industries through a New Investment in North America. Press Release. June 17, 2025.

Haigney, S. Poor API Quality Threatens a Healthy Supply. 

https://www.pharmtech.com/view/poor-api-quality-threatens-a-healthy-supply

Thomas, F. Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients. 

https://www.pharmtech.com/view/drug-digest-securing-the-supply-chain-for-small-molecule-apis-and-excipients

The new facility offers cleanroom packaging and high-sensitivity analytical testing.