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Feliza Mirasol is the science editor for 

Rentschler Biopharma, a biopharmaceutical contract development and manufacturing organization (CDMO), announced on Sept. 3, 2024, that it has launched an expanded service offering at Stevenage, UK, the company's advanced therapies site. With the expanded offering, Rentschler Biopharma now offers a new lentiviral vector (LVV) manufacturing toolbox for producing advanced therapy medicinal products (ATMPs), which complements the company’s existing adeno-associated virus (AAV) viral vector services.

The Stevenage site offers customized solutions for accelerating viral vector programs and includes novel, license-free toolboxes for AAVs and LVVs, according to a company press release. The company’s proprietary human embryo kidney 293 (HEK293) cell line offers additional time and cost savings for advanced therapy projects. The company’s services contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, Rentschler Biopharma stated in the press release.

“We made a strategic investment in the cell and gene therapy sector, starting with adeno-associated viral vector services, so we could offer our development and manufacturing expertise and sector experience to support innovators in this fast-developing space,” said Christiane Bardroff, chief operating officer, Rentschler Biopharma, in the press release. “We are now pleased to build on our success and augment this offering with lentiviral vectors. Our company remains dedicated to evolving our portfolio to enhance the health and quality of life for seriously ill patients around the world.”

Growing research and positive clinical results across a range of therapeutic applications has increasingly brought LVVs to the forefront in the advanced therapy space. Using LVVs for gene transfer has been applied to treat several genetic diseases, including beta-thalassemia. LVVs have also been used introduce genes to T-cells to modify them and generate immunity against cancer (1).

“The new lentiviral vector manufacturing toolbox highlights our commitment to providing cutting-edge solutions that enable our clients to advance their viral vector programs from pre-clinical and clinical development to market. By integrating lentiviral vector process development and manufacturing to our services, we are better serving the market by meeting the growing needs of the evolving and vibrant global advanced therapies sector,” said Robert Panting, general manager, ATMP, Rentschler Biopharma, in the press release.

Manufacturing LVVs has traditionally been difficult because 

, which are more delicate and sensitive than non-enveloped viruses. LVVs are therefore more sensitive to temperature, pH, shear, etc. (2).

Because of their sensitivity, purification approaches for LVVs are typically gentler, often applying one single-step chromatography and one concentration/buffer exchange step; however, final sterile filtration is still a challenge and may impact titer and yield. Designing a manufacturing process must therefore consider how to mitigate yield loss all along the way (2).

1. Ghosh, S.; Brown, A. M.; Jenkins, C.; Campbell, K. Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges. 

 (1), 7–18.
2. Mirasol, F. Comparing Viral Vectors for Gene Therapy Delivery. 

Articles

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

Rentschler Biopharma Offers New Toolbox for LV Manufacturing

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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

Steriline, based in Lake Como, Italy, will display RVFCM11-S, its new, robotic vial filling and capping machine, in the company’s home country at CPHI Milan from Oct. 8–10, 2024, Steriline announced in a press release on Sept. 2, 2024 (1).

Designed specifically for primary packaging of cell and gene therapies, RVFCM11-S measures 2.25 m by 1.65 m, contains nested vials in four different sizes, and can be configured to fill pre-filled syringes and cartridges, according to Steriline (1). The machine uses two robots for handling of primary containers with no glass-to-glass contact, and an integrated, double-wall isolator that minimizes contamination risk.

“Our new RVFCM11-S addresses the specific challenges associated with the production of cell and gene therapies, where sustainability is often determined by product loss,” said James Rorke, vice president of operations at Steriline North America, in the press release. “The entire supply chain can now benefit from a solution that ensures minimal loss, a high degree of sterility assurance, and compliance with [European Union good manufacturing practice] Annex 1 requirements.”

Vials are removed discretely by RVFCM11-S’s use of magnetic levitation, to move each vial to a robot arm. The vials then proceed to the filling station, with a check-weigh system integrated into the design to ensure precise filling (1). A second robot arm handles capping, and places vials back into their nests.

Overall, the machine has a production capacity of 15 nested vials, syringes, or cartridges per minute, according to Steriline (1). Additional software-based tracking features are deployed to ensure that temperature-sensitive materials do not exceed their time limit in the solution, therefore preserving pharmacological efficacy.

Steriline said in the press release that the RVFCM11-S would attract both pharmaceutical professionals, and other companies, that want to enhance their production efficiency while keeping in line with the stringent standards of the industry.

“Steriline remains committed to developing innovative pharmaceutical packaging solutions,” Federico Fumagalli, Steriline commercial director, said in the press release. “Our aim is to advance the industry by providing more efficient systems that optimize the production process for the greater good.”

Previous Steriline showcases at CPHI have included its RVFCM2, designed to integrate robotics and isolators with a zero-loss philosophy, at the 2023 conference in Barcelona (2). And in 2022 in Frankfurt, Steriline displayed the VCFM100, a vial filling and capping machine under double-wall isolator that had been developed for the purpose of increasing production capacity for a contract development and manufacturing organization that at the time was supplying COVID-19 vaccines throughout the world (3).

The RVFCM11-S will be on display during CPHI Milan at the Steriline stand, located in room A42, Hall 18, according to the press release (1).

1. Steriline. Steriline Unveils New Robotic Vial Filling Machine at CPHI Milan 2024. Press Release. Sept. 2, 2024.
2. Steriline. Robotic Vial Filling and Capping Machine (RVFCM2) Under Isolator. 

, Oct. 9, 2023.
3. Steriline. CPHI Frankfurt 2022: Steriline Leverages on Compactness and Versatility. Press Release. Nov. 1, 2022.

Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

Steriline to Show New Robotic Vial Filling and Capping Machine at CPHI Milan 2024

Mike Hennessy Jr. is the Chairman and CEO of 

High Angle Shot of a Working Desk of a Successful Person in Office with Cityscape Window View. | Image Credit: © Gorodenkoff - stock.adobe.com

On Aug. 14, 2024, the World Health Organization (WHO) declared mpox (previously called monkeypox) as a public health emergency of international concern (PHEIC) as a result of the increasing rates of infection that are being witnessed in African countries (1). The International Health Regulations Emergency Committee of independent experts had advised WHO on the level of concern about the spread of the virus and the potential for the virus to penetrate other continents.

Two years ago, in July 2022, the multi-country outbreak of mpox was also declared a PHEIC; however, after less than a year, in May 2023, that PHEIC was declared over as a sustained decline in global cases was seen (1). A new virus strain of mpox, clade 1b, has emerged and has been rapidly spreading.

When the first PHEIC was declared for mpox in 2022 for a less deadly strain of the virus, the bio/pharma industry went to bat quickly and utilized experience from the COVID-19 pandemic to work efficiently. One of the main players from the 2022 outbreak, Bavarian Nordic, is proving its worth once again, committing to donate 40,000 doses of its mpox vaccine to the Africa Centers for Disease Control and Prevention (2). “Mpox is spreading at an alarming rate in Africa, calling for further action from the international community,” said Paul Chaplin, president and chief executive officer of Bavarian Nordic, in a press release (2).

The 40,000 vaccines from Bavarian Nordic will form part of a larger donation of 215,000 doses that will be provided by the European Commission’s Health Emergency Preparedness and Response Authority (3). However, many more vaccines will be needed, and WHO has triggered the Emergency-Use Listing process for mpox vaccines and started working with countries and vaccine manufacturers on potential donations (1).

“The emergence of a new clade of mpox, its rapid spread in eastern DRC [Democratic Republic of Congo], and the reporting of cases in several neighbouring countries are very worrying,” warned Dr Tedros Adhanom Ghebreyesus, director-general of WHO, in his PHEIC declaration announcement (1). “On top of outbreaks of other mpox clades in DRC and other countries in Africa, it’s clear that a coordinated international response is needed to stop these outbreaks and save lives.”

1. WHO. WHO Director-General Declares Mpox Outbreak a Public Health Emergency of International Concern. Press Release, Aug. 14, 2024.
2. Bavarian Nordic. Bavarian Nordic Receives Order from HERA and Announces Significant Donation of Vaccines in Response to the Mpox Outbreak in Africa. Press Release, Aug. 13, 2024.
3. EC. Mpox: HERA to Donate Over 215,000 Vaccines to Africa CDC Amid Urgent Outbreak. Press Release, Aug. 14, 2024.

Mike Hennessy Jr is president and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Responding to Mpox. 

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

Responding to Mpox

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

Retro classic typewriter from circa 1950s with sheet of paper and aged books on wooden desk front aquamarine wall background. Nostalgic writer's work place concept. Vintage old style filtered photo | Image Credit: © BrAt82 - stock.adobe.com

In 2024, the warmest day in recent history was experienced on Earth, with the daily global average temperature reaching 17.16 °C (1). In fact, over the past 13 months there has been a vast difference in temperature when compared with previous records, which is demonstrating the impact of climate change at an alarming scale.

Trying to stem the impact of global warming is something that is continually being assessed across many global industries, including the bio/pharma industry. Various initiatives and strategies have been put in place, such as 

 (2), aimed at helping economies and society in general become more sustainable. However, according to research, the healthcare sector contributes to 4.4% of global carbon emissions (3).

A report from NIRAS, a global manufacturing consultancy company, has set out a strategic framework for decarbonization and emphasized the importance of ‘future state planning’ for life sciences companies (4). Future state planning is a methodical approach whereby companies start by analyzing current practices in detail to see where change is needed and then develop a framework through which they can measure progress being made while also ensuring accountability.

However, future state planning, as with decarbonization in general, should not just be considered as a singular event, as specified in the report: “Future state planning is not a one-time effort; it is an ongoing process that requires regular review and adjustment […] Embarking on the decarbonization journey is a commitment to transformative change. It is a voyage that requires meticulous planning, steadfast determination, and the agility to adapt to new discoveries and innovations along the way.”

“As the world moves towards a more sustainable future, the process industries must take bold steps to decarbonize their operations,” said Lis Thodberg, sustainability director, NIRAS, in the report (4). “This transition is not just an environmental imperative but also a strategic business move, as stakeholders increasingly value sustainability.”

1. Copernicus. New Record Daily Global Average Temperature Reached in July 2024. News Release, 25 July 2024.
2. EC. COM(2019) 640 Final. Communication from the Commission: 

. Brussels, Belgium (December 2019).
3. Dehipawala, S.; Goldman, E.; Hwang, E.; et al. The Pharmaceutical Industry’s Carbon Footprint and Current Mitigation Strategies: A Literature Review. Poster Presentation at the 2023 ISPOR Annual Conference, Boston, MA, 7–10 May 2023.
4. NIRAS. 

Decarbonisation in the Process Industries: What Can Manufacturers Do Now?

When referring to this article, please cite it as Thomas, F. Strategic Decarbonization. 

Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.

Strategic Decarbonization

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: We are revising our audits and inspections programs and wanted some advice on best practices. How can we limit the number of on-site audits or inspections?

A: Companies need to find the right balance between the different types of audits, be it a questionnaire, a remote (virtual) or an on-site audit, or a combination of these. A number of reasons have to be taken into consideration, including criticality of the product or service, the feasibility of the type of audit, the regulatory expectations, and others. Here, the company is in charge of the decision making.

This is different in the case of inspections. It is at the discretion of the inspecting authority what type of inspection they will perform. The inspected company can greatly help such an inspection succeed if they are suitably prepared for the various scenarios, especially with regards to remote inspections.

Let us first address the audit program. It is essential to understand that there are fundamental differences between the different types of audits. The following examples shall exemplify this.

A third-party logistics (3PL) company with its own warehouses and fleet of transport vehicles is to be audited. The 3PL fills in a questionnaire sent by the customer. According to the answers, the company is in full compliance with all good distribution practice requirements. The customer decides to perform a virtual audit of the 3PL. This allows for a review of the actual documentation and a virtual site tour. Everything is clean, and there is sufficient space for performing the work. All seems to be fully compliant. However, the customer decides to perform an on-site audit. The documentation is the same; although, it is now possible to have several documents next to each other and cross-reference easily. Importantly, the premises and operations can now be seen firsthand, making it possible to see problems such as cracks in the concrete floor of the warehouse, paint peeling off the wall, insect traps that hadn’t been cleaned for too long, aisles blocked by pallets because there actually isn’t enough space, and electronic access controls being bypassed by doors that were propped open. Just be aware.

In reverse, if you the customer get inspected, you do not want to be the one who isn’t open and honest. You want to present truthfully what you do and how you do it. And this you want to do equally well, whether it is a virtual or an on-site inspection. Plenty has been published about preparing for on-site inspections, and companies are usually well prepared. The issues are still with preparing best for virtual audits. Specifically, can you share all documents electronically, including logbooks or other paper documentation? Can you show live video of all areas without a wobbling (handheld) camera? These are the two most challenging aspects of such inspections.

Updating your audits and inspections program gives you a chance to make sure you are as prepared for inspections as you would want your suppliers to be prepared for your audits.

Siegfried Schmitt is vice president, Technical at Parexel.

®
Vol. 48, No. 9
September 2024
Pages: 34

When referring to this article, please cite it as Schmitt, S. Keeping Audit and Inspection Programs Current. 

Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.

Keeping Audit and Inspection Programs Current

Cheryl Barton is director of PharmaVision, 

Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com

On 1 Aug. 2024, the European Artificial Intelligence Act (AI Act) came into force (1). The AI Act is designed to ensure that artificial intelligence (AI) developed and used in the European Union (EU) is trustworthy, and that there are safeguards in place to protect people’s fundamental rights. In January 2024, the European Commission (EC) launched a package of measures to support European small and medium enterprises (SMEs) and start-ups in the development of trustworthy AI, and in May, the EC established an AI Office (2,3). In July 2024, the amended European High Performance Computing Joint Undertaking (EuroHPC JU) Regulation came into force to further develop, deploy, extend, and maintain the EU supercomputing and data infrastructure (4). This paved the way for the establishment of AI Factories, dedicated AI supercomputers, that can be used for training General Purpose AI (GPAI) models (5).

This article was published in the September 2024 issue of 

The AI Act aims to harmonize AI across the EU to encourage the uptake of this technology and support innovation and investment. The AI Act also prohibits certain AI practices and sets out regulations on “high-risk” AI systems and those that pose transparency risks (

Figure 1. Definition of artificial intelligence (AI)-based product safety and risk-based approach. (Figure courtesy of the author)

The AI Act also introduces rules to reduce the systemic risk of systemic GPAI models that are capable of performing a wide range of distinct tasks such as the generation of human-like text (6). The new legislation imposes stricter regulation and fines on tech companies operating generative AI models (i.e., DeepMind and OpenAI will fall under the general-use AI category and would be classed as minimal risk). However, developers of high-risk models would be asked to evaluate models, assess and mitigate systemic risks, conduct adversarial testing, report serious incidents to the EC, ensure cybersecurity, and report on their energy efficiency (6).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the AI Act and “believes in the potential of applying AI to deliver benefit for patients, life-science companies, and society” (7). However, it stresses that “the regulatory frameworks governing the use of AI in research, development, and manufacture must be fit-for-purpose, risk-based, non-duplicative, globally aligned, and adequately tailored” (7). When AI-enabled tools are used in pharma R&D, they are exempt from the requirements of the EU AI Act; however, developers and deployers of AI-enabled digital health tools (DHTs) and AI-enabled digital medicine would be impacted by the AI Act, but they would not be considered high risk (8).

Enforcement of the AI rules will be phased in

EU Member States have a year to designate national competent authorities to oversee the application of the AI rules. The Commission’s AI Office will oversee the implementation of the AI Act at the EU level, and be responsible for enforcing the rules for GPAI models (1).

The EC will establish the following three advisory bodies to support the implementation of the rules:

European Artificial Intelligence Board—

to ensure the uniform application of the AI Act across EU Member States and to cooperate between the EC and the Member States.

A scientific panel of independent experts—

to offer technical advice and input on enforcement. The panel can issue alerts to the AI Office about risks associated with GPAI models.

a diverse set of stakeholders to offer guidance to the AI Office (1).

The AI Office has the power to enforce these policies. Companies that do not comply with the rules will be fined 1.5–7% of their global annual turnover depending on the violation (e.g., companies can be fined up to 1.5% for supplying incorrect information) (1).

The AI Act’s regulations will take effect in phases. Rules regarding prohibited practices will apply as of 2 Feb. 2025; obligations on GPAI models will apply as of 2 Aug. 2025; and both transparency obligations and obligations on high-risk AI systems will apply as of 2 Aug. 2026 (9).

In the interim, the EC launched the AI Pact to encourage and support organizations before implementing the AI Act (10). The EC has urged the industry to voluntarily commit to the AI Act requirements before the legal deadline. In November 2023, it obtained responses from more than 550 organizations, and the AI Office initiated the development of the AI Pact, based upon two pillars:

establish a gateway to engage the AI Pact network, encourage the exchange of best practices, and provide practical information on the AI Act implementation process

encourage AI system providers and deployers to prepare early and take actions towards compliance with requirements and obligations set out in the legislation.

The AI Pact has enabled the EC to work with stakeholders to support them in understanding the objectives of the AI Act, to adapt and prepare for the implementation of the AI Act, and to share knowledge and build trust in AI technologies (10).

Meanwhile, the Joint Research Centre continues to undertake independent, evidence-based research to support EU policies and determine the societal impact of the AI Act across Europe.

The EU AI Act sends a clear message to the rest of the world that Europe is taking AI very seriously and emphasises the importance of trust, transparency, and accountability. The EC is the first governmental body to create a legal infrastructure on AI and has paved the way for others to emulate and replicate.During the coming months, rules will be phased in and European standards will be refined. Therefore, companies need to work closely with the AI Office and other relevant authorities to ensure the safe deployment of AI solutions that will be beneficial to society and drive future innovation in Europe.

European Artificial Intelligence Act Comes into Force

Commission Launches AI Innovation Package to Support Artificial Intelligence Startups and SMEs

Commission Establishes AI Office to Strengthen EU Leadership in Safe and Trustworthy Artificial Intelligence

Setting Up of AI Factories is Now Possible after EuroHPC Regulation Amendment

The EU Passes the AI Act and its Implications for Digital Medicine Are Unclear

International Bar Association. The Regulation of Foundation Models in the EU AI Act. 

EFPIA Statement on the Use of AI in the Medicinal Product Lifecycle in the Context of the AI Act

Cheryl Barton, PhD,is founder and director of PharmaVision, Pharmavision.co.uk.


Vol. 36, No. 8
September 2024
Pages: 9-10

When referring to this article, please cite it as Barton, C. European Artificial Intelligence Act Comes into Force. 

What impact will the AI Act have on pharma and digital medicine?

Thermo Scientific’s DNAPac RP HPLC columns | Image courtesy of Thermo Fisher Scientific.

The Thermo Scientific SurePac Bio 550 SEC MDi columns enable fast separations of adeno-associated virus (AAV) monomers and aggregates. The columns are designed with 3 µm monodisperse particles and inert (MDi) column hardware aimed at providing superior AAV monomer retention and higher resolution of aggregates in cell and gene therapies. These columns offer fast run times, optimal separation efficiency, and reliable results with the goal of accelerating time-to-market for novel therapeutics. In addition, Thermo’s DNAPac RP HPLC columns are offered in semi-preparative formats to enable scalability in the development of DNA/RNA oligonucleotides. The DNAPac RP semi-preparative columns are designed so that laboratories can navigate the expanding field of oligonucleotide therapies and precision medicine. The DNAPac RP semi-preparative column utilizes unique chemistry for enhanced performance across wide ranges of pH, temperature, and mobile-phase compositions, offering precise separations and sample purification.

Thermo Scientific’s columns offer fast run times, optimal separation efficiency, and reliable results.

Separation and Purification Columns for Enhanced Retention

Freudenberg Medical’s Y-connector assemblies | Image courtesy of Freudenberg Medical.

Freudenberg Medical has added custom single-use assemblies to its product portfolio. The new offerings consist of, but are not limited to, single-use Y-connector manifolds, tubing assemblies, and bottle cap assemblies with multiple inlets/outlets. Bottlecap assemblies with Y-connector tubing are commonly used in labs and in current good manufacturing practice (CGMP) bioprocesses during critical fluid transfer applications. The single-use assemblies are cleanroom manufactured. The Y-connector overmolds offer unobstructed flow within a critical fluid path and can prevent leaks from occurring. Leaks are commonly seen with standard fluid couplings, fittings, and connectors. The expanded portfolio complements the company’s existing PharmaFocus Premium product line, which contains high purity, platinum-cured silicone tubing and sanitary ends for single-use systems. The company’s tubing, molded components, and systems are used in bioprocessing, biotechnology, lab processes, GMP manufacturing, and small batch processes as well as for the production of cell and gene therapies, messenger RNA, biosimilars, and regenerative proteins.

Freudenberg Medical’s new offerings include single-use Y-connector manifolds, tubing assemblies, and bottlecap assemblies, among others.

Custom Single-Use Assemblies

The ROSS CDA-300 Dual Shaft Mixer | Image courtesy of Charles Ross & Son Company.

The ROSS CDA-300 Dual Shaft Mixer includes two agitators: one is a two-wing anchor agitator that is driven by a 20 horsepower (HP) totally enclosed fan cooled (TEFC) high efficiency, inverter duty motor; the second agitator is a high-speed disperser that is powered by a 60 HP TEFC high efficiency, inverter duty motor. The mixer is designed with a disperser that has an open disc blade, capable of traveling roughly 5000 feet per minute to induce vigorous turbulent flow. This vigorous flow creates a vortex into which dry ingredients can be added for fast wetting. The change can on the CDA-300 features an air/oil hydraulic lift that allows the use of multiple mix cans constructed of stainless steel type 304. The mix cans include heating/cooling jackets on the sidewalls and bottom for temperature control. Easy discharge is enabled by a three-inch manually operated stainless-steel flush bottom ball valve with tri-clamp connection. The mixer can be easily moved around the production floor on casters. The mixer is designed for vacuum operation to produce air-free products with highly repeatable density, viscosity, composition, and dispersion quality. The NEMA 12 control panel includes a seven-inch color touch screen for user-friendly operation, while providing independent agitator speed controls, load display, cycle timer, and other functions as well as ensuring safety with limit switches that prevent operation in the absence of the mix can or when the agitators are not in the mixing position.

Charles Ross & Son Company has introduced the ROSS CDA-300 Dual Shaft Mixer, consisting of two agitators and a disperse with an open disc blade. 

Dual Shaft Mixer for High-Performance Applications

Asahi Kasei Medical’s virus removal filters | Image courtesy of Asahi Kasei Group

Asahi Kasei Medical’s Planova virus removal filters are used in the manufacturing processes of biopharmaceuticals and plasma derivatives. The filters are also used in biosafety testing services and biopharmaceutical contract development and manufacturing operations. Planova comprises cellulose hollow-fiber membrane filters that were developed to specifically remove viruses from biotherapeutic products. The line was launched in 1989 and was followed by Planova BioEX hydrophilic polyvinylidene fluoride hollow-fiber membrane filters in 2009. Both product lines have been adopted worldwide. The latest offering is Planova S20N, a next-generation line of cellulose hollow-fiber membrane filters, which was launched in 2022. This latest addition features robust virus removal capability and simplified operation.

Asahi Kasei Medical now offers its Planova virus removal filters for use in biopharma manufacturing and plasma derivatives manufacturing.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach