Feliza Mirasol is the science editor for 

Feliza Mirasol

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.

Articles

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.

Podcasts

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

Drug Solutions Podcast: Equipment Trends for Addressing Production of New Modalities

United States-based Latigo Biotherapeutics (Latigo), a clinical-stage biotechnology company specializing in non-opioid pain treatments that target pain at its source, announced on March 17, 2025 that has closed a Series B round of funding with $150 million (1). The funds will be used to advance the company’s highly selective Nav1.8 inhibitors, which are currently in clinical development for the non-opioid treatment of pain. The funds will also be used to develop the company’s broader pipeline of drug candidates.

Led by funds managed by Blue Owl Capital, the financing round included participation from Deep Track Capital, Access Biotechnology, Qatar Investment Authority, Cormorant Asset Management, Sanofi Ventures, Rock Springs Capital, UPMC Enterprises, and Kern Capital. Westlake Village BioPartners, Foresite Capital, 5AM Ventures, and Alexandria Venture Investments—already existing investors—also contributed to the financing round (1).

“The need for non-opioid pain treatments has never been more urgent, and this financing allows us to accelerate the development of our robust portfolio of pain medicines that have the potential to transform the treatment landscape,” said Nima Farzan, chief executive officer of Latigo Biotherapeutics, in a company press release (1). “We appreciate the support of our new and existing investors as we work to bring best-in-class, non-addictive pain treatments to patients.”

In August 2024, Latigo reported positive Phase I results for its lead non-opioid pain medicine candidate, LTG-001, an oral, selective Nav1.8 inhibitor. LTG-001 is in development for treating acute pain at its source. The Phase I trial, a first-in-human clinical trial, showed that LTG-001 was well tolerated and had rapid absorption (2). The Phase I trial aims to evaluate the safety, tolerability, and pharmacokinetics of the candidate in healthy volunteers through single-ascending dose and multiple-ascending dose cohorts.

Earlier in March 2025, LTG-001 was granted fast track designation by FDA after demonstrating a favorable safety and tolerability profile with predictable pharmacokinetics in the Phase I trial. LTG-001 works by blocking peripheral sensory neurons that are responsible for pain signals. Blocking these peripheral neurons prevents the transmission of pain signals to the central nervous system (3).

“We are pleased [FDA] has granted [f]ast [t]rack designation to LTG-001, recognizing its potential to transform the treatment landscape for acute pain by targeting pain at its source,” Farzan said in a press release issued at the time the fast track designation was granted (3). “This marks an important milestone for Latigo and reinforces the promise of LTG-001 as a highly selective, well-tolerated non-opioid approach for treating pain. With this designation, we look forward to working closely with [FDA] to accelerate development and bring this much-needed non-opioid medicine to patients rapidly.”

Meanwhile, as part of the Series B financing, Kevin Raidy, senior managing director at Blue Owl Capital, has joined Latigo’s board of directors. “The field of pain management is long overdue for innovation beyond opioids, and we believe Latigo is well-positioned to advance novel, non-addictive treatments that could make a real difference for patients,” Raidy said in the March 17 press release (1).

Latigo Biotherapeutics Closes $150 Million in Series B Financing to Advance Non-Opioid Pain Therapeutics.

 Press Release. March 17, 2025.
2. Latigo Biotherapeutics. Latigo Biotherapeutics Announces Positive Phase 1 Data for Lead Non-Opioid Pain Medicine Candidate and Appoints Neil Singla, M.D., Chief Medical Officer. Press Release. Aug. 19, 2024.
3. Latigo Biotherapeutics. Latigo Biotherapeutics Granted FDA Fast Track Designation for LTG-001, Potential Best-in-Class Nav1.8 Inhibitor for the Non-Opioid Treatment of Acute Pain. Press Release. March 3, 2025.

With financing led by Blue Owl Capital, Latigo will use the funds to further develop non-opioid pain treatments as well as develop other candidates in its pipeline.

Latigo Biotherapeutics Raises $150 Million to Advance Non-Opioid Pain Therapeutics

A discussion on the most significant/innovative ingredients over the past year and a look ahead at new innovative ingredients anticipated. 

DCAT Week 2025: Key Ingredients in Pharmaceutical Manufacturing

In an interview with the PharmTech Group ahead of DCAT Week 2025, Christine Mya-San, a global account manager at Roquette Pharma Solutions, highlights the standout pharmaceutical ingredients in the past year. These important ingredients are those that logically address the pharmaceutical industry's biggest topics and biggest challenges, she says. 

A good example of such ingredients are low nitrite excipients that support drug manufacturers and their ongoing mission to reduce the risk posed by nitrosamines, she points out. Roquette has worked to assess and certify its existing low-nitrite products to support reformulation efforts. In addition, the company is developing solutions to enhance medication adherence, such as β-cyclodextri

 (Kleptose DC), which improves solubility and provides effective taste-masking, and mannitol (Pearlitol 200 GT), which offers enhanced compressibility and resistance to tablet capping, thus enabling the production of smaller, more convenient mini-tablets, Mya-San notes.

Looking ahead, Mya-San anticipates that pharmaceutical ingredients such as high-performance tablet coatings will optimize tablet manufacturing compared to traditional sugar coatings. "Recently, we put the spotlight on high-performance coatings, highlighting features such as low processing temperatures, which help in two-fold: first, for reduced energy usage, and second for that lowered nitrosamine formulation [risk]," she states.

Meanwhile, in terms of innovation, she highlights the potential of 3D drug printing and artificial intelligence to play a central role in the identification and large-scale production of new therapeutic ingredients. Three-dimensional printing, for example, could enable the printing of customized medicines tailored to individual patient needs, including the combination of multiple medications into a single dosage form.

DCAT Week 2025 is being held March 17–20 in New York City.

Christine Mya-San, Global Account Manager, Roquette Pharma Solutions

Christine Mya-San is a global account manager at Roquette Pharma Solutions. Her love of the sciences started as a Cancer Research Fellow at the National Institutes of Health. Post fellowship, she started working at Covance as a risk mitigation specialist and sales representative. Mya-San has worked at notable companies such as Sigma-Aldrich (Merck KGaA) and at Honeywell Research Chemicals. Previous roles at Roquette include Americas channel management and global market management for the over-the-counter and nutraceuticals markets. Mya-San received her Bachelor of Science in biology at Dickinson College (Carlisle, Penn.) and her Master of Business Administration from Saint Louis University.

Videos

Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.

Discussion on the need for continuous manufacturing in biologics manufacturing with Enzene's Russell Miller.

DCAT Week 2025: Industry Need for Continuous Biologics Manufacturing

Although perfusion-based biologics manufacturing has been around for decades, the biopharmaceutical industry has historically favored fed-batch processes. Now, however, regulators are showing increased interest in continuous manufacturing, similar to the adoption of continuous manufacturing in small molecule production, says Russell Miller, vice-president, Global Sales & Marketing, Enzene, in an interview with the PharmTech Group ahead of DCAT Week 2025, which is being held on March 17–20 in New York City.

Enzene has been pioneering the shift towards fully connected continuous bioprocessing, Miller emphasizes. He explains that only fully connected continuous manufacturing integrates the entire production process, from bioreactor to downstream purification, in a seamless flow. Fully connected continuous manufacturing platforms offer several key advantages, such as reducing the cost of goods, enhancing product quality by preventing degradation such as that seen in longer fed-batch runs, and boosting productivity up to 10-fold.

In addition, a fully connected continuous process can compress the number of batches required to support clinical trials, which can accelerate the path to clinic, he states. Yet, despite these advantages, only about 2% of biologics are currently manufactured continuously.

“[It] is my feeling that continuous manufacturing is on the forefront of a change in biologics manufacturing as we move forward. It has the opportunity to solve different problem statements that clients may have, whether it's product quality or cost of goods or productivity. [Those] are some pretty compelling areas that folks pay attention to when it comes to biologics, especially in the mammalian [cell culture-] based processes, because these are not things that happen in a day or so. Biologics manufacturing from mammalian-based systems take 12,14, 18, 20-plus days to execute, and that's a lot of time and planning. So, anything that can be done to make that time more efficient, more productive is beneficial to the industry,” Miller says.

Russell Miller, Vice-President, Global Sales & Marketing, Enzene

Russell Miller is a results-oriented business development leader with more than two decades of experience driving growth in the pharmaceutical and biotech industries. His expertise spans analytical services, formulation development, and manufacturing, providing him with a deep understanding of the drug development process. Spending more than a decade at Catalent Pharma Solutions, he consistently exceeded sales targets and spearheaded strategic initiatives, including the successful reinvigoration of sales in the Northeast region and the design and implementation of a global Inside Sales Group. He has also held leadership roles at Vectura, ANI Pharmaceuticals, and Scotwork, consistently demonstrating his ability to establish companies as leading contract development and manufacturing organizations, reinvigorate sales funnels, and streamline operations. At Enzene, Miller's focus is on forging strategic partnerships and delivering solutions that exceed expectations, driving the company's continued success.

Russell Miller, vice-president of Global Sales & Marketing at Enzene, explains that continuous bioprocessing is poised to change biologics manufacturing moving forward. 