Feliza Mirasol is the science editor for 

Feliza Mirasol

On April 1, 2025, BioPure, a provider of single-use solutions and part of Watson-Marlow Fluid Technology Solutions (WMFTS), announced that it has refined the manufacturing of its single-use sanitary connector, BioClamp, to offer sustainability benefits to users. The company will showcase the connector at INTERPHEX 2025, occurring April 1–3 in New York City.

BioPure, which introduced the first single-use sanitary bioclamp for bioprocessing in 1998, according to a company press release (1), has optimized BioClamp in terms of its design and its manufacturing process. Under the new manufacturing process and new design, the connector is 13% lighter in weight compared to the previous BioClamp model. The adoption of advanced automated assembly has also resulted in 26% less carbon dioxide emissions during manufacturing across the full lifecycle of the product (1). BioClamp securely attaches sanitary fittings and plays a crucial role in single-use critical fluid transfer lines.

“From enhanced production to shipment, use in a bioprocess and end-of-life disposal, BioClamp is designed for sustainability while maintaining the highest quality standards,” said Mark Lovallo, product manager for WMFTS, in the press release (1). “BioClamp is efficiently manufactured, pre-assembled, and packaged at our global network of state-of-the-art Class 7 cleanrooms, which gives users of our sanitary bioclamp confidence in quality and sustainability as they scale up their production. These facilities are ISO14001 certified and powered by renewable energy.”

An additional upgrade to the bioclamp is an advanced ergonomic hinge that makes it easier to close and simplifies the set-up of an assembly process, allowing for quick changeovers. Other features and benefits include:

reduced distortion on polymeric fittings when subjected to heat

suitability for sterilization using autoclave and gamma irradiation

suitability for either single-use or multiple-use applications

reliable availability of global manufacturing and supply network.

WMFTS has the goal of reaching net-zero for its scope 1 and 2 emissions (i.e., emissions that are in its direct control) and reducing scope 3 emissions (i.e., those emissions that the company is indirectly responsible for, up and down its value chain) by 2030. Optimizing the manufacturing process for the BioClamp connector is a significant step toward that goal.

Speaking with Nicole Hunter, head of Global WMArchitect at WMFTS last year at 

 the PharmTech Group discussed the importance of optimizing fluid-handling workflows in the bioprocessing space and the efficiencies that single-use technologies (SUTs) can offer for biomanufacturing (2).

“One of the main reasons to have really good workflows is to reduce the risk in your process. You want to … safeguard your therapeutic during the process and expedite getting that drug product to the patient,” Hunter said in the interview (2).

Hunter noted that the big advantages SUTs bring are flexibility and adaptability to bioprocessing. “What [SUTs] have been able to do—in moving away from stainless-steel systems—is to allow for quick changeover between drug products. One facility can make multiple drug products really easily; the manufacturing systems can be quickly assembled for the different drug products and changed out as, and when, needed. [SUT] also reduces risk of cross contamination because you're literally using that assembly for that drug product and then changing to another one,” she explained in the interview (2).

Attendees can visit WMFTS at Booth #2753 at INTERPHEX 2025.

1. Watson-Marlow Fluid Technology Solutions. 

BioPure Advances Manufacturing of BioClamp to Bring Significant Sustainability Benefits to Its Users

. Press Release. April 1, 2025.
2. Mirasol, F. 

Single-Use Technologies Reinforce Fluid-Handling Workflows (INTERPHEX 2024)

Articles

With advanced manufacturing, BioPure’s BioClamp connector is manufactured to be 13% lighter than the previous model, resulting in a 26% reduction in carbon dioxide emissions across the full lifecycle of the product.

WMFTS’ BioPure to Showcase Single-Use Bioclamp with Refined Manufacturing at INTERPHEX 2025

Beckman Coulter Life Sciences, a provider of laboratory automation and innovation and an operating company of Danaher Corporation, has launched the CytoFLEX mosaic Spectral Detection Module, the industry’s first modular spectral flow cytometry solution, the company announced on March 18, 2025 (1).

The CytoFLEX mosaic Spectral Detection Module offers substantially greater fluorescence sensitivity when connected to the CytoFLEX LX or S Flow Cytometers. The solution addresses challenges with dim and complex multicolor experiments because it can detect nanoparticles as small as 80 nm. The instrument provides two unmixing algorithms and up to 10 autofluorescence channels, with up to 88 detection channels. As a result, richer data can be generated from spectral analysis that can help untangle the complexities of biological systems and diseases faster. It also allows for a nuanced understanding of immune cell subsets and their functions and interactions by simultaneously detecting multiple markers.

“As a central feature of the CytoFLEX platform, this innovation is focused on pairing ease-of-use with powerful, sensitive acquisition technology to remove the intimidation encountered in many flow cytometry instruments,” said Matthew Goff, product manager, Beckman Coulter Life Sciences, in a company press release. “Investigators can now easily switch between their true conventional detection system and this advanced spectral detection system, while maintaining a familiar sample management and user experience, all without having to invest in a separate instrument. Along with experimental continuity and evolution offered by a more flexible approach, this delivers a unique solution for sustainability needed by many institutions.”

Compared to conventional flow cytometry (2), spectral flow cytometry acquires the full emission spectrum of each antibody-associated fluorophore across all lasers, rather than just measuring the peak of emission. This advanced ability delivers a more detailed and precise characterization of cellular properties, which can then advance the understanding of complex biological systems and diseases within each sample compared to older, traditional approaches, according to the company in the release.

The CytoFLEX mosaic spectral detection module runs on a unique algorithm that is capable of improving resolution compared to other available methods. It also offers unmixing accuracy checks for ensuring efficiency. Accompanying the instrument is the CytExpert software, used in spectral cytometry to reduce the need for extensive training, which can thus speed up the transition to spectral technology. The module also comes with tools to ease the full spectral workflow and offers access to the FluoroFinder panel builder and a Cytobank premium license that provide all the tools needed to transition from sample preparation to analysis of complex spectral data in an easy manner.

“I found the software very easy to learn and was able to start my first experiments in only a few hours,” said Tamar Tak, coordinator of the Flow Cytometry Facility at Leiden University Medical Center, in the press release. “A feature I really like is that it allows me to do an extensive QC [quality control] of the unmixing. You get a plot with all the normalized spectra of your fluorochromes and a table with similarity indices. This allows me to see if a tandem dye has degraded, or perhaps the wrong antibody was added. The autofluorescence settings are another highlight, allowing flexibility depending on your samples—from human tissue to complex samples of microorganisms.”

The new module is available in two configurations, the CytoFLEX mosaic 88 for the CytoFLEX LX Flow Cytometer and the CytoFLEX mosaic 63 for the four-laser CytoFLEX S Flow Cytometer.

Beckman Coulter Life Sciences Launches Industry-First Modular Spectral Flow Cytometry Solution

. Press Release. March 18, 2025.
2. McKinnon, K. M. Flow Cytometry: An Overview. 

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

Beckman Coulter Life Sciences Launches Modular Spectral Flow Cytometry Module, First of Its Kind in Industry

FDA’s Center for Drug Evaluation and Research (CDER) issued a 

 to India-based Aspen Biopharma Labs (Aspen) in March 2025 following its inspection of the company’s facility in Malakpet Village, Rangareddy, in Hyderabad, India. The inspection took place Sept. 16–21, 2024. According to the warning letter, FDA inspectors found significant deviations from current good manufacturing practice (CGMP) in the production of APIs (1).

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” FDA stated in its March 5, 2025 letter (1).

Deviations found during the inspection include, but are not limited to:

a failure in the design and construction of the buildings and facilities used to manufacture the API in a way that minimizes potential contamination and facilitates appropriate cleaning, maintenance, and operations

failure to demonstrate that the company’s manufacturing process can manufacture an API in a reproducible manner while meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintaining equipment

failure to provide records, either originals or copies, that are readily available and promptly retrievable during the retention period

failure to design a documented, ongoing stability testing program that monitors the stability characteristics of API and to use the results for confirming appropriate storage conditions as well as for retest or expiry dates (1).

FDA’s warning to Aspen is the latest in a series of warning letters the agency has issued this year to India-based API manufacturers. In February 2025, the agency separately issued warning letters to 

 (Tyche) regarding deviations from CGMP for APIs (2,3).

In the warning letter to Jagsonpal, FDA based its observations on an inspection conducted on March 20, March 27, and April 3, 2024 at the company’s facility in Bhiwadi Dist., Alwar, in Rajasthan, India. During its inspection, the agency observed a failure of the company’s quality unit to exercise its responsibility to ensure compliance with CGMP in the manufacture of the API produced at the company’s contract facility. In addition, the inspector was denied entry by persons present at the site upon arrival on March 15, 2024, only to be granted entry on March 20, 2024; however, during inspection, access to requested documents was limited. Finally, a (b)(4) drug was manufactured at an unregistered facility and was not listed by the company as required under 

)Title 21, Part 207.41(a) (4), which caused the (b)(4) drug to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

“[F]ailure to provide current listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p),” FDA stated in the letter (2).

Meanwhile, the warning letter to Tyche was based on an inspection conducted at this company’s Sarpavaram, Kakinada, India, manufacturing plant on Aug. 12–16, 2024. In this letter, the FDA inspector observed several deviations, including but not limited to:

a failure to record all quality-related activities at the time these are performed

failure to clean equipment and utensils to prevent contamination or carry-over of any material that can alter the quality of the APIs produced beyond the official or other established specifications

failure to test the identity of each batch of incoming production material (3).

Warning Letter: Aspen Biopharma Labs Private Limited

, March 5, 2025 (accessed March 27, 2025).
2. FDA. 

Warning Letter: Jagsonpal Pharmaceuticals Limited

 Title 21, 207.41(a) (Government Printing Office, Washington, DC), 

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-D/section-207.41

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

Novartis has strengthened its presence in Slovenia following the official opening in February 2025 of a new viral vector production facility (VIFA One) in Mengeš. Novartis invested €40 million (US$43 million) into the facility, which is the company’s first specialized viral vector manufacturing facility in Europe (1). With this investment, Novartis significantly expands its research and production capabilities in the biopharmaceutical sector.

The facility will support the production of viral vectors for breakthrough cell and gene therapies (CGTs) developed for treating certain autoimmune and genetic diseases and cancers. The facility features a fully automated production environment, including advanced robotics, designed to ensure precision and efficiency at all stages of the production process under one roof. The facility also introduces a state-of-the-art methodology aimed at setting a new industry standard but also significantly increasing Novartis’ capabilities to deliver breakthrough therapies under the highest quality standards (1).

Construction on the new facility began in 2023 and represents a significant boost to both the Slovenian economy and the country’s scientific community. "Novartis investments, which are among the leading foreign direct investments in the country, have made a significant contribution to the development of Slovenian science over the past two decades,” said Igor Papič, PhD, Minister of Higher Education, Science, and Innovation of the Republic of Slovenia, during the facility’s opening ceremony in February, where he was the keynote speaker (1). “I am pleased that Novartis is successfully cooperating with universities and scientific research institutions, and that it places great emphasis on developing young talent and transferring knowledge into practice. Cooperation between business and science and a stimulating scientific research and innovation environment, which is also supported by the State with generous funding, are key to the successful development of Slovenian society. They also create an environment that will be even more attractive to foreign investment."

The opening of the Mengeš facility follows a cycle of intense investment by Novartis in Slovenia. In 2024, Novartis’s investments in the country had a total value of €257 million (US$277 million) and mainly focused on the construction of new facilities and the introduction of new technologies (2).

A combination of the new investments and growth in business activity resulted in the need for new employees, leading to a growth in workforce in Slovenia in 2024. In that year, Novartis hired more than 560 new staff in Slovenia, bringing its total workforce in the country to more than 3900 employees by year’s end. Novartis also signed a strategic partnership with the University of Ljubljana, which further strengthened the company’s cooperation with academia and contributes to the joint development of knowledge and innovation (2).

“Novartis globally invested US$9.3 billion in research and development in 2024,” said Aymeric Royere, Novartis Slovenia country president, in a Jan. 31, 2025 company press release (2). “This shows our commitment to continue bringing new innovative medicines to patients worldwide in therapeutic areas where there are still significant unmet treatment needs. At Novartis in Slovenia, we also ensured that all key Novartis medicines, including the newly launched innovative medicines, have been available to patients in Slovenia.”

Slovenia’s Ljubljana and Mengeš locations support more than half of Novartis priority medicines in various stages of development, production, or services, Novartis noted in its Feb. 5, 2025 press release (1). "Slovenian experts significantly contribute to technological advancement and innovation in the research, development, and production of Novartis innovative medicines, addressing the greatest health challenges in society,” said Steffen Lang, PhD, member of the executive committee, and president, Operations, Novartis, in the press release (1). “Their knowledge, expertise, and achievements have been recognized and valued by Novartis from the very beginning and represent the fundamental reason for continuous further investments in Slovenia. One of these is the new viral vector production facility, which, as the only such Novartis production facility in Europe, has significant strategic value.”

Since entering the Slovenian market, Novartis has invested approximately €3.5 billion (US$3.8 billion) in the country, aimed primarily at research, development, and production capacities as well as sustainable environmental technologies. Investments totaling approximately €500 million (US$541 million) are currently underway at the Ljubljana and Mengeš locations, furthering the company’s growth in Slovenia.

In Slovenia, Novartis Opens Its First Specialized Viral Vector Production Facility in Europe

. Press Release. Feb. 5, 2025.
2. Novartis. Novartis in Slovenia Sees a Growth in Workforce and an Enhanced Role in the Global Novartis Network in 2024. Press Release. Jan. 31, 2025.

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

AstraZeneca has entered into an exclusive license agreement with Alteogen, a Korea-based bio venture company, in which AstraZeneca will gain access to Alteogen’s novel hyaluronidase-utilizing Hybrozyme platform technology, ALT-B4. Under the agreement, AstraZeneca will acquire worldwide rights to use ALT-B4 for the development and commercialization of subcutaneous formulations of several oncology assets in AstraZeneca’s portfolio (1).

Through the agreement, Alteogen will be responsible for clinical and commercial supply of ALT-B4 to AstraZeneca, and AstraZeneca will make an upfront payment to Alteogen as well as additional payments should specific development, regulatory, and sales-related milestones be achieved. Alteogen will also receive royalties on the sales of commercialized products.

“We are dedicated to advancing new medicines for people with cancer and that includes new methods of delivery which are more convenient for patients, physicians and healthcare systems,” said Cristian Massacesi, chief medical officer and Oncology chief development officer, AstraZeneca, in a March 17, 2025 company press release (1). “We look forward to collaborating with Alteogen on several assets in our portfolio with the goal of bringing new subcutaneous options to patients that can transform the way cancer care is delivered.”

Alteogen’s ALT-B4 is a proprietary human recombinant hyaluronidase enzyme that was developed using Hybrozyme technology. ALT-B4 is designed to enable the large-volume subcutaneous administration of parenteral drugs typically administered as an intravenous infusion. ALT-B4 works by temporarily hydrolyzing hyaluronan within the extracellular matrix. Hyaluronan is a major component of the extracellular matrix that plays a key role in regulating inflammation (2). Developing subcutaneous formulations for oncology therapies offers potential advantages, including time savings for patients, clinical staff, and health systems as a result of shorter administration times (1).

“We are excited to expand our Hybrozyme [t]echnology by collaborating with AstraZeneca in their development of novel subcutaneous cancer medicines to meet the needs of patients,” said Soon Jae Park, PhD, CEO, Alteogen, in the press release. 

 in China to boost life sciences R&D and manufacturing. On March 21, 2025, the company said it plans to invest $2.5 billion in Beijing over the next five years under which it will establish a new global strategic R&D center. The investment will support both major research and manufacturing agreements that will further advance life sciences in China (3).

The investment is part of a strategic partnership that AstraZeneca has with the Beijing Municipal Government and the Beijing Economic-Technological Development Area Administrative Office. The investment includes agreements with the biotech companies Harbour BioMed, Syneron Bio, and BioKangtai.

AstraZeneca Enters License Agreement with Alteogen for Subcutaneous Formulations of Multiple Oncology Assets

. Press Release. March 17, 2025.
2. Petrey, A. C.; de la Motte, C. A. Hyaluronan, a Crucial Regulator of Inflammation. 

,101. DOI: 10.3389/fimmu.2014.00101
3. AstraZeneca. AstraZeneca to Invest $2.5 Billion in New Global Strategic R&D Centre, Biotech Agreements and Manufacturing in Beijing. Press Release. March 21, 2025.

Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.

AstraZeneca and Alteogen Sign License Agreement for Developing Subcutaneous Formulations of Oncology Assets

, the discussion revolves around current and anticipated new trends in equipment and technologies for optimizing the manufacture of new biotherapeutic modalities, such as cell and gene therapies. Automation technologies and continuous manufacturing emerges as significant drivers for the future biomanufacturing landscape. Innovative and progressive technologies will also play a role in establishing and maintain sustainability practices in the industry.

Kerry Love, PhD, Co-Founder and CEO, Sunflower Therapeutics

Kerry Love, PhD, is the co-founder and CEO of Sunflower Therapeutics, a women-owned and led biotechnology company delivering next-generation protein manufacturing solutions that anyone can use to create innovative new medicines, vaccines, foods, and other bio-produced materials. Love is an organic chemist by training, performing her doctoral studies at MIT, and a biotech entrepreneur at heart, having founded two companies and contributed to the starting of many more over the past twenty years. Love has authored more than 40 scientific papers and patents.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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The growing development of new biotherapeutic modalities will rely heavily on automation and progressive technologies. 