CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

Behind the Headlines, Episode 20

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

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

Pharmaceutical process development and API manufacturing company CARBOGEN AMCIS has successfully completed a first inspection by the French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (ANSM) at its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, the company announced on March 24, 2025 (1). The inspection was part of a routine process conducted by ANSM to gauge good manufacturing practice (GMP) compliance, and as such, CARBOGEN AMCIS has been granted a GMP certificate for the French facility.

“This achievement reflects our team's dedication and hard work,” said Angie Stevens, vice president of CARBOGEN AMCIS’ Drug Product Business Unit, in a company press release (1). “With this certification, we look forward to actively supporting our customers in bringing new drugs to market and shaping a bright future together.”

The certificate permits the Saint-Beauzire facility to manufacture and release clinical and commercial sterile drug products; ANSM had granted the site authorization to manufacture, test, and release drug products upon its February 2023 opening, with the first clinical batch released in January 2024 (1).

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market,” said Helen Caddy-Leach, head of Business Development, Drug Product, in the release (1). “With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence.”

“Having a cutting-edge facility dedicated to the development and manufacture sterile drug products, including to a commercial scale, strengthens our ability to offer comprehensive end-to-end services, from drug substance to drug product,” said Stephan Fritschi, CEO of CARBOGEN AMCIS, also in the release (1). “This integrated approach is a significant advantage in today’s competitive pharmaceutical landscape and provides added value for our clients.”

The Saint-Beauzire site traces its roots back to August 2020, when CARBOGEN AMCIS 

 (now US$113 million) investment to open two new manufacturing facilities, one in its home country of Switzerland focusing on APIs, and the other, the company said at the time, located in France and concentrating on custom development and manufacturing of parenteral drug products (2).

In September 2024, Caroline Ailhas, Pharmaceutical Development director for CARBOGEN AMCIS, 

 eBook, on the topic of prioritization of formulation strategies for temperature-sensitive biotherapeutics (3).

Ailhas explained that maintaining the structure and functionality of a molecule and defining the required duration of stabilization are the main factors challenging formulation development for temperature-sensitive molecules. The latter can vary from a few days to months, or even years. “The definition of this duration significantly impacts the formulation strategy,” Ailhas said (3).

Elsewhere in France in the first quarter of 2025, 

 a €50 million (US$52 million) investment in its site in Mourenx, with the intention of making the site a center of excellence within the company’s network for contract manufacturing of APIs and drug substances for biologics that have been FDA approved (4). That followed a previous €7.3 million (now US$7.6 million) investment, made in the Mourenx site in August 2022, to create a pilot workshop supporting a growing demand for APIs, particularly highly potent APIs to treat cancer.

CARBOGEN AMCIS said the Saint-Beauzire site completes its group portfolio, which includes seven other sites across France, Switzerland, the United Kingdom, China, and The Netherlands offering current GMP (CGMP)-compliant technologies designed to help bio/pharmaceutical companies bring next-generation medicines to market (1).

1. CARBOGEN AMCIS. CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site. Press Release. March 24, 2025.
2. CARBOGEN AMCIS. CARBOGEN AMCIS Announces Major Investments of More Than CHF 100 million in Switzerland and France. Press Release. Aug. 17, 2020.
3. Mirasol, F. Prioritizing Formulation Strategies for Temperature-Sensitive Biotherapeutics. 

Pharmaceutical Technology Trends in Formulation

 eBook September 2024.
4. Axplora. Axplora Announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site. Press Release. Feb. 12, 2025.

Articles

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

The Texas-based contract development and manufacturing organization Benuvia Operations has been awarded a five-year contract by the National Institutes of Health (NIH)’s National Institute on Drug Abuse (NIDA) for good manufacturing practice (GMP) synthesis of the naturally occurring psychedelic compound psilocybin, which comes from certain types of mushrooms, as well as other bulk drug substances (1).

Benuvia said in a press release on March 25, 2025 that the contract supports R&D of high-quality APIs for substance use disorders and mental health conditions, initially focusing on synthesis and scale-up of psilocybin, which is a Schedule I substance under the Controlled Substances Act (1). Psilocybin was granted breakthrough therapy designation by FDA in 2018 for treatment-resistant depression, and 2019 for major depressive disorder.

“This contract highlights our leadership in the development and manufacturing of controlled substances under GMP conditions,” Terry Novak, Benuvia CEO, said in the press release (1). “We are honored to support NIH’s efforts in advancing groundbreaking research into innovative therapies for substance use disorders and mental health conditions. Our state-of-the-art capabilities enable us to supply the highest-quality pharmaceutical compounds that meet the most rigorous regulatory standards.”

The contract stipulates that Benuvia Operations will manufacture and deliver GMP-grade psilocybin for NIDA preclinical toxicity studies as well as clinical trials (1). Clinical studies are currently evaluating psilocybin as a potential treatment for depression, anxiety, and substance use disorders.

“Our mission at Benuvia is to provide high-purity, federally approved substances for scientific research and pharmaceutical development,” Novak said. “We look forward to working with the NIH to help evaluate psilocybin’s therapeutic potential for the millions of patients suffering from these conditions.”

Previously, on March 11, 2025, Benuvia Operations announced that it 

 (Certificado de Boas Práticas de Fabricação [CBPF]) from Brazil’s National Health Surveillance Agency (ANVISA), such certification being essential, according to the company, as a regulatory prerequisite for pharmaceutical companies to manufacture and distribute products in Brazil (2).

“Achieving ANVISA’s CBPF certification underscores Benuvia’s strategic commitment to providing high-quality, compliant pharmaceutical manufacturing specifically tailored to Brazil’s rapidly growing healthcare market,” Novak said at the time (2). “ANVISA CBPF certification allows us to be the preferred provider for companies seeking a partner with quicker market entry, reduced regulatory hurdles, and stronger credibility among regulatory bodies, healthcare providers, and pharmaceutical customers.”

“Psychedelic Drugs: Considerations for Clinical Investigations,”

 concerning the use of such drugs—psilocybin among them—for treatment of various medical conditions, including psychiatric and substance use disorders (3).

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, director, Division of Psychiatry, Center for Drug Evaluation and Research, FDA, said in a press release announcing the draft guidance (3). “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

The other bulk drug substances beside psilocybin that will be future areas of focus for Benuvia under the contract with NIDA were not disclosed by name in the Benuvia press release (1).

1. Benuvia Operations. Benuvia Operations Awarded NIH Contract for GMP Synthesis of Psilocybin and Other Bulk Drug Substances. Press Release. March 25, 2025.
2. Benuvia Operations. Benuvia Operations Granted GMP Certification from Brazil National Health Surveillance Agency (ANVISA). Press Release. March 11, 2025.
3. FDA, 

Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.

Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances

Feliza Mirasol is the science editor for 

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

Oral Fabhalta (iptacopan), developed by Novartis, has been approved by FDA for treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria in those patients, the first approved treatment for that condition (1). C3G is a progressive, ultra-rare kidney disease with an average age at diagnosis of approximately 23 years old; approximately half of those diagnosed progress to kidney failure within 10 years, requiring lifelong dialysis and/or a kidney transplant.

C3G is further described by Novartis as an overactivation of a part of the immune system, the alternative complement pathway, that causes deposits of C3 protein to build up in kidney glomeruli, the blood vessel network that filters waste and removes extra fluid from blood (1). This can result in inflammation and/or glomerular damage causing proteinuria, or protein in urine, hematuria (blood in urine), and reduced function of the kidneys. The disease has previously been typically treated with a combination of supportive care, broad immunosuppression, and symptom management.

FDA has approved Novartis’ oral iptacopan treatment twice before; in December 2023, for treatment of adults with paroxysmal nocturnal hemoglobinuria, and August 2024, for reduction of proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression (1).

A Phase III trial (APPEAR-C3G), in which iptacopan was taken orally twice daily, showed clinically meaningful proteinuria reduction as early as 14 days, and sustained at 12 months (1).

“C3G is a debilitating disease often affecting young people, impacting many aspects of their physical and emotional health, and our previous treatment options came with significant challenges,” Carla Nester, MD, professor of Pediatrics-Nephrology at the University of Iowa, and APPEAR-C3G study co-investigator, said in a Novartis press release (1). “This approval of Fabhalta is historic for the entire C3G community as now, for the first time, we have a therapy that is believed to treat the underlying cause of the disease, providing the potential for a new standard of care for patients.”

The most common adverse reactions in the Phase III study were nasopharyngitis and viral infections; meanwhile, the symptoms not specifically tied to kidney function that patients with C3G may face include high levels of fatigue, certain mobility issues that can affect day-to-day activities, and mental health effects including depression and anxiety (1).

“As someone whose family has suffered from C3G across multiple generations, it is difficult to fully express the physical and emotional challenges of living with this unrelenting disease,” said Lindsey Fuller, C3G patient and co-leader of C3G Warriors. “To finally have an approved treatment—and one that can be taken orally—is something people with C3G have been waiting for. Today’s approval brings new hope for me, my family, and so many others.”

Prior to FDA’s decision, announced in the March 21, 2025 Novartis press release, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) 

 extended the indication for iptacopan to include treatment of adult patients with C3G (2).

“We extend our deepest gratitude to the patients and investigators who participated in our clinical trials, without whom this first FDA approval in C3G wouldn’t have been possible,” said Victor Bultó, president US, Novartis, in the company’s press release. “With this additional approval for Fabhalta—the second in kidney disease—we will leverage our established capabilities and expertise to bring this innovative treatment to patients in need as we work to help transform care for people living with kidney diseases.”

1. Novartis. Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan)—The First and Only Treatment Approved in C3 Glomerulopathy (C3G). Press Release. March 21, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025. Press Release. Feb. 28, 2025.

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy

, 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

TOP NEWS on grunge world map | Image Credit: © Sean K - stock.adobe.com

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of heads of regulatory authorities that are responsible for regulating human and veterinary medicines in the European Economic Area, have published their joint European Union (EU) medicines agencies’ network strategy (EMANS) to 2028, “Seizing Opportunities in a Changing Medicines Landscape,” which EMA said both its management board and HMA have adopted (1).

“I am delighted to present our joint EMA/HMA network strategy to 2028. With new legislation on the horizon, we are preparing for the most significant regulatory reform in decades,” Emer Cooke, EMA executive director, said in a press release (1). “In these uncertain times, when our environment is evolving constantly, we need to be agile and to be able to anticipate transformative changes, as well as to better address supply chain security. Innovations in the development of medicines, including the use of artificial intelligence (AI), require a significant update to our network strategy so that we can seize the opportunities that they present.”

EMANS 2028 is described by EMA as a comprehensive update of EMANS 2025, which was developed to cover the years 2021 to 2025 and has six focus areas, introducing what EMA and HMA call the “One Health Approach”:

accessibility (facilitating pathways to medicines access through the EU’s healthcare systems)

leveraging data, digitalization, and AI (with the end goals of improved decision-making, optimized processes, and increased efficiency)

regulatory science, innovation, and competitiveness (to create a research environment that accelerates the translation of innovation)

antimicrobial resistance and other health threats

availability and supply (for both humans and animals)

sustainability of the network, taking advantage of technological advances (1).

“With the strategy to 2028, our aim is to ensure a transparent, forward-looking and science-driven roadmap to managing the network's public health priorities,” Maria Lamas, chair of HMA Management Group, said in the release (1). “In the face of a new global framework, it is important that the European medicines regulatory agencies contribute to EU competitiveness. We are committed to catalyze the innovation of medicines and their manufacture by leveraging every opportunity to promote public and animal health.”

 that EMANS 2028 was open for public consultation in October 2024, a period which ended Nov. 30, 2024 (2). At the time, EMA said that new regulations (e.g., legislation to address public health emergencies and reform of the EU medicines regulations) and technical advances, such as the use of AI, were some of the main drivers for the changes to the original strategy.

The 2021–2025 EMANS was published in December 2020, and 

 that examined its achievements from January 2021 to June 2023 found that the COVID-19 pandemic, which was still in its first year at the beginning of that timeframe, strengthened the network, allowing it to be on track to meet its goals and objectives regarding drug availability, data management, innovation, antimicrobial resistance, supply chain challenges, and sustainability of the network (3). EMA said that EMANS 2028, prepared in a post-pandemic setting, draws on extensive experience gained in the EU from responding to COVID-19 (1).

The final, adopted version of EMANS 2028 is available via PDF download at 

1. EMA. Joint Strategy Sets Direction of EMA and EU Medicines Regulatory Agencies to 2028. Press Release. March 18, 2025.
2. EMA. Seizing Opportunities in a Changing Medicines Landscape. Press Release. Oct. 9, 2024.
3. EMA. Midterm Report on 2025 Network Strategy Highlights Good Progress During Critical Period of the Pandemic. Press Release. Dec. 20, 2023.

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

EMA and HMA Publish Joint Network Strategy to 2028

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

DCAT Week Interview with Markus Laubscher

While attending the Drug, Chemical & Associated Technologies Association (DCAT) Week from March 17–20, 2025 in New York City, 

® talked with Markus Laubscher, general manager of Orbia Fluor & Energy Materials Pharma Business Unit, about Orbia’s latest efforts to develop sustainable solutions while keeping abreast of regulatory changes, offering a look into the future of the industry.

Laubscher became the general manager of Orbia Fluor & Energy Materials’ Pharma Business Unit in July 2024. Since that time, he has overseen Orbia’s focus—under its Koura Global brand—on sustainable solutions for medical propellants for respiratory medicines.

“What you will see over the next decade is that more and more pharma companies are going to invest into restructuring their production so that they can start to use the newer green solutions, and you will see a number of regulatory processes being followed where the regular medical regulatory bodies are going to critically look at the safety and efficacy of these propellers, and make sure that they give them their approval if they're happy,” Laubscher says in the interview. “So we'll see a period of approvals [and] regulatory activity in the transition, and investments that are needed in order to make sure that the new production facilities manage the new products. And for the patients, there shouldn't be any interruption in terms of having access to their medication—and actually, there shouldn't be any kind of change in how they will use their products.”

Click the video above to watch the full interview.

Markus Laubscher, General Manager of Orbia Fluor & Energy Materials Pharma Business Unit

Markus Laubscher leads the Orbia Fluor & Energy Materials team, focusing on innovating and delivering medical propellants for respiratory medicines. Driven by Orbia’s purpose to advance life around the world by improving outcomes for both the patient and the planet, Laubscher is a key voice in the future of medical propellants and its responsible application in the pharmaceutical sector. As a leader at Orbia, he is driving innovation to meet evolving health needs while ensuring sustainability in an industry facing regulatory shifts. With Orbia’s deep-rooted history in pharma, Laubscher is at the forefront of adapting to changing market dynamics, particularly during the critical transition to next-generation propellants, a shift expected to reshape the industry over the next decade. His insights into regulatory adaptation, sustainability, and market evolution make him a valuable resource for media covering this intersection of pharma, chemistry, and innovation.

PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.

DCAT Week 2025: Sustainability in Medical Propellants

Stamford, Conn.-based ITT said its Engineered Valves and Habonim brands will have a presence at INTERPHEX in New York City in April 2025, jointly presenting solutions designed to provide customers with reliability, cost savings, a greater level of process controls, and reduced risk of operational disruption (1).

In a press release issued ahead of the conference, on March 20, 2025, ITT said its brands would show upgraded, dynamic valve platforms, including the redesigned 970 Handwheel Operated Valve, the EnviZion Valve that ITT said can reduce downtime by approximately 90%, and the PfuZion Diaphragm and Bonnet Assembly that compliments Engineered Valve’s Bio-Tek valve body, allowing for error-proof diaphragm installation and reduction of diaphragm replacement maintenance time from as much as 30 minutes to as few as three minutes (1).

The Habonim brand will show the latest in hygienic ball valve technology including standardized, electropolished, forged bodies and end connections, which ITT said makes the sanitary ball valves suitable for a range of applications (1).

ITT said that the most notable of its offerings being shown at INTERPHEX will be Engineered Valves’ Integrated Sensing Platform IO-Link technology, which is designed to digitize point-to-point valve communication for hygienic diaphragm valves that have sensing devices, thereby reducing the complexity of the protocol (1). According to the press release, the platform is simple, cost-effective, and saves space.

“Our team is looking forward to joining industry peers at INTERPHEX to discuss the innovations shaping the digitization of pharmaceutical and biotechnological manufacturing, and how Engineered Valves continues to create cutting-edge valve solutions for the benefit of its customers and the industry’s evolution to smart manufacturing,” said Dave Loula, global product director, ITT Engineered Valves, in the release (1). “Customers continue to demand cost savings, improved valve performance, and reduced maintenance requirements to optimize production efficiency and eliminate downtime without impacting overall drug purity in the process. Our solutions featured at this year’s show meet those needs while allowing global customers to install, operate and maintain valve technology safely and more efficiently.”

 on March 21, 2024, an $11 million expansion of its testing capabilities at three of its industrial process sites, in Obernkirchen, Germany; Vadodara, India; and Dammam, Saudi Arabia, aiming to increase capacity for large project awards in the company’s flow business (2).

® examined the smart equipment and tools being adopted in the pharmaceutical industry to advance manufacturing 

 defining Industry 4.0 as “accelerating the adoption of smart machinery, interconnected sensors, and artificial intelligence-driven control systems, which are enabling real-time monitoring and data-driven decision-making” (3).

“Predictive maintenance is a key application where equipment can self-monitor for wear and tear and alert operators before a breakdown occurs, minimizing downtime,” said Caterina Funaro, Competence Center manager at IMA Active, in that article (3). “Smart factories are becoming a reality, where data collected from machines optimize operations in real time.”

ITT will be found at Booth 3337 at INTERPHEX, which will be held at the Javits Center in New York City from April 1–3, 2025 (1).

®’s INTERPHEX coverage before, during, and after the 2025 conference can be accessed at 

1. ITT. ITT Engineered Valves and Habonim Bring Advanced Industry 4.0 Solutions for Flow Control to INTERPHEX 2025. Press Release. March 20, 2025.
2. Husni, D. G. 

, Apr. 1, 2024.
3. Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Upgraded and dynamic valve platforms as well as advanced sensing will be some of the components of ITT’s exhibit.

ITT Brands’ Industry 4.0 Solutions for Flow Control to Be Shown at INTERPHEX

Krohne, a company headquartered in Duisburg, Germany that specializes in process instrumentation, has announced its display at INTERPHEX 2025 in New York City will highlight the company’s Flexmag 4050C electromagnetic flowmeter (1).

According to a press release from Krohne, the flowmeter is the first of its kind wiith a biocompatible, disposable flow tube that has been designed specifically for single-use biopharmaceutical applications, such as filtration processes, chromatography, and buffer and media preparation (1,2). The flowmeter is highly accurate and factory calibrated, eliminating the need for 

 calibration due to the fact that the instrument’s electromagnetic meter will not drift over time, according to a company press release.

The flow tube is designed with a single barb fitting, suitable for both braided and non-braided hoses. This design meets regulatory requirements for being adapted to single-use systems (1,2). Construction of the tube has been designed for minimal hold-up volume without obstruction, according to the company. The volumetric flow measurement that is provided is described by Krohne as stable, direct, and accurate.

Disposable, single-use flow tubes are packaged in individual pouches that are double-sealed, Krohne said, with the transmitter being able to accommodate two different tube sizes; this affords the end user the opportunity to exchange the tube to handle two different flow ranges without the need for recalibration (1,2).

 director of Global Corporate Business Development at ChargePoint Technology, to discuss processing equipment trends, and Dunne said single-use technology is one of those at the moment (3).

“Obviously, you get a lot of flexibility with the single-use technology, and a lot of reduced risk in terms of the operator protection,” Dunne said in the interview. “But of course, it's got the added advantage of cost being a main driver for a lot of the companies like CMOs [contract manufacturing organizations].”

In some of the applications for which the Flexmag flowmeter has been developed, automation has been increasingly used—but with a caveat, according to Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products, i

“From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” Christopher said in the article, adding that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance. “But,” he qualified, “full end-to-end automation is rare” (4).

Krohne will be displaying the Flexmag 4050C flowmeter at Booth 1462 at INTERPHEX, which will be held at the Javits Center in New York City from April 1–3, 2025 (1).

1. Krohne. Krohne Highlights Flexmag 4050C Electromagnetic Flow Meter at INTERPHEX 2025. Press Release. March 18, 2025.
2. Krohne. Single-Use Electromagnetic Flow Meter. 

A Greater Need for Containment: Processing Equipment Trends.

, Dec. 16, 2024.
4. Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

The Flexmag 4050C flowmeter has a biocompatible, disposable flow tube that Krohne says has been specifically developed for single-use applications such as filtration processes or chromatography.

Featured Content

Behind the Headlines, Episode 20

ICH Q12 and Post-Approval Changes

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know