Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

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

Axplora, a Germany-based API small-molecule and antibody-drug conjugate (ADC) manufacturer, announced on Feb. 12, 2025 a €50 million (US$52 million) investment is being made in its site in Mourenx, France, 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 (1).

Previously, in August 2022, a €7.3 million (now US$7.6 million) investment 

 to create a pilot workshop supporting a growing demand for APIs, particularly highly potent APIs to treat cancer. That investment was announced by what was then the Novasep-PharmaZell Group; Novasep and PharmaZell, which had just merged in April 2022, were then unified along with Farmabios under the brand name Axplora in October 2022 (2).

The new tranche of money, Axplora said, will be used to upgrade the Mourenx site’s infrastructure and capabilities related to peptide purification in a biologics environment. The company is also looking toward the development of next-generation therapeutics, specifically glucagon-like peptide-1 (GLP-1) drugs targeting obesity and diabetes (1).

“GLP-1 therapies represent a paradigm shift in medicine, offering targeted therapies for complex diseases with unprecedented efficacy and tolerability,” Arul Ramadurai, Axplora chief commercial officer, said in the release. “This initiative, built on strong customer partnerships, reinforces Axplora’s role as a trusted partner in manufacturing life-changing, breakthrough medicines.”

 Hikma Pharmaceuticals USA’s liraglutide injection, the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL from Novo Nordisk (3). The generic was indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise. FDA noted at the time that there is a drug shortage of liraglutide injection and certain other GLP-1 medications, and the agency is thus prioritizing assessment of generic-drug applications for drugs in shortage to help improve patient access to these medications, aligning with the mission Axplora has set forth with this investment.

“This project is testament to our pioneering expertise in industrial chromatography, and working closely with our client, we target having the facility BLA [biologics license application]-ready in 15 months,” Pere Patón-Morales, PhD, Axplora chief operating officer, said in the release. “To achieve this our internal teams are working closely with partners in a strong cross-functional project team, well-supported by the local authorities. We are looking forward to a bright future at Mourenx.”

Axplora said its vision is for the Mourenx site to remain a “key contributor to Axplora’s API network” into the 2030s, and that construction and infrastructure development enabled by this most recent investment would begin immediately, with a goal of having the site’s first supplies of GLP-1 therapies available in 2026 (1). Mourenx is one of nine Axplora API manufacturing sites currently operating across Europe and India, helping the company partner with more than 900 pharmaceutical and biotech companies worldwide, according to the press release.

1. Axplora. Axplora Announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site. Press Release. Feb. 12, 2025.
2. Axplora. Farmabios, Novasep and PharmaZell are Now Axplora. Press Release. Oct. 19, 2022.
3. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.

Articles

This site was previously the beneficiary of a €7.3 million (US$7.6 million) investment, made in 2022, earmarked for the production of HPAPIs to treat cancer.

Axplora Announces €50 Million Investment in GLP-1 Manufacturing in France

FDA has approved the SpringWorks Therapeutics treatment Gomekli (mirdametinib) for treatment of adult and pediatric patients aged two and older who have neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) that are not amenable to complete resection (1). SpringWorks, a commercial-stage biopharmaceutical company headquartered in Stamford, Conn., announced the approval on Feb. 11, 2025, adding that a marketing authorization application for mirdametinib has been validated by the European Medicines Agency and is currently under review, with a decision from the European Commission expected later in 2025.

Saqib Islam, SpringWorks CEO, said FDA’s approval was a win for NF1-PN patients in the United States.

“The NF1-PN patient community has a great need for more treatment options,” Islam said in the press release. “With today’s approval, we are honored to serve both adults and children with NF1-PN and provide them with a therapy that has the potential to shrink their tumors and offer meaningful symptomatic relief. We are grateful to each clinical trial participant, their families, the investigators, and the patient advocacy groups involved in the journey towards making Gomekli available in the US. I am proud that we are delivering on our commitment to patients with devastating diseases with our company’s second FDA approval in less than 18 months.”

SpringWorks said that Gomekli was approved under priority review by FDA—having previously been granted orphan drug and fast track designations—and that the company received a rare pediatric disease priority review voucher (1).

The future of the rare pediatric disease priority review voucher 

 one such designation granted late in 2024 was to 

eladocagene exuparvovec-tneq (Kebilidi, PTC Therapeutics),

 for treating adult and pediatric patients with aromatic L-amino acid decarboxylase deficiency (2,3).

FDA’s approval of mirdametinib for patients with NF1-PN was based on results of a Phase IIb trial (ReNeu) that enrolled 114 patients nearly evenly split between adults and children (58 adult patients, 56 pediatric) (1). There are approximately 40,000 people living with NF1-PN in the US, according to SpringWorks, and most of them have not had previous access to an approved medication.

“Patients with NF1-PN often face significant challenges with their health and have had limited treatment options to manage this devastating condition,” Christopher Moertel, MD, medical director, pediatric neuro-oncology and neurofibromatosis programs and Kenneth and Betty Jayne Dahlberg Professor of Pediatrics, University of Minnesota, and lead investigator of the ReNeu trial, said in the SpringWorks press release. “It was very encouraging in the ReNeu trial to see that GOMEKLI provided deep and durable responses, with a manageable safety profile that enabled patients to stay on therapy. This approval represents an important advance, especially for adults who previously did not have an approved treatment.”

“We are excited to celebrate the extraordinary milestone of our partners and long-term friends at SpringWorks for the NF1-PN community. This FDA approval shows the power of collaboration to advance innovative science for drugs that may otherwise not have been taken forward,” said Annette Bakker, PhD, Children’s Tumor Foundation CEO, in the release.

Gomekli, currently being manufactured in both 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension that dissolves easily in water, is expected to be available in the US through a specialty pharmacy and distributor network by the end of February 2025.

1. SpringWorks Therapeutics. SpringWorks Therapeutics Announces FDA Approval of Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN. Press Release. Feb. 11, 2025.
2. National Organization for Rare Disorders. Congress: Reauthorize the Rare Pediatric Disease Priority Review Voucher Program. 

, July 23, 2024.
3. FDA. FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency. Press Release. Nov. 14, 2024.

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

FDA Approves SpringWorks Therapeutics Treatment for Adult and Pediatric Patients with NF1-PN

Young female tech or scientist performs protein assay | Image Credit: © tilialucida - stock.adobe.com

This year marks the 10th anniversary of the International Day of Women and Girls in Science, which was recognized on Feb. 11, 2025. There has traditionally been an unbalanced gender gap in the areas of science, technology, engineering, and mathematics (STEM) that is limiting the potential of skilled workers in the pharmaceutical industry. According to the United Nations, fewer than 30% of engineering graduates are women (1). Women also face unique challenges in these fields, including a lack of opportunity in senior positions. With the demand for highly skilled personnel high, what is the bio/pharmaceutical industry doing to encourage girls to enter STEM fields and women to pursue higher level jobs in pharma?

Michelle Bridenbaker, COO, Unbiased Science, stresses the critical nature of STEM programs in developing talent and ensuring a sustainable, and relevant, workforce. “In terms of the pharma industry specifically, a strong scientific background is a solid foundation for the rigor, discipline, and critical as well as innovative thinking that modern pharma success is built on,” says Bridenbaker. “As employers, pharma companies need to actively encourage women through mentorship and leadership preparation, so that they see and realize their full potential.”

Opportunities for STEM-related jobs in the pharmaceutical industry are abundant and are continuing to grow, according to Agnes Cwienczek, director of Product Management at ArisGlobal. It is crucial to foster education in these fields to meet the growth of technology.

“While more and more pharma companies have established dedicated STEM programs and are fostering related career paths, men continue to outnumber women in this field across the globe, particularly at the higher levels,” says Cwienczek. “It should be in our collective interest to invest further in these kind of promotions—not only for purposes of equality but also to capitalize on the skills and significant contributions made by women to science and research.”

Gender ‘norms’ often inhibit girls from entering what are traditionally seen as school subjects that are ‘for boys’. Pushing back on these stereotypes is crucial, not just for girls, but also for boys. Equal access to STEM fields without labeling specific areas as ‘gender-specific’ is important for STEM programs, says Sabine Gölden, eLearning & Training Lead at MAIN5.

“Gender should never be the basis for deciding which field of study is right for you, regardless of any evolutionary advantages or disadvantages,” says Gölden. “Ultimately, someone’s path should be determined by their unique talents, passion, dedication, and interests, not by their gender. As a mother of two, I observe with great interest how societal expectations continue to shape role models,” remarks Gölden. “A clear example is toy advertisements—on many popular websites, you can filter toys by ‘Boys’ or ‘Girls,’ resulting in distinctly different suggestions. And this is just one of many examples. That’s why I strongly believe STEM programs in schools are a valuable opportunity to challenge stereotypes and give every student the chance to discover whether STEM is the right fit for them.”

To foster interest in science and engineering for girls, exposure to these fields at an early age is imperative. “STEM programs for girls in school play a crucial role in fostering interest, confidence, and skills in science, technology, engineering, and mathematics,” explains Jean Redmond, the chief operating officer at Biologit. “These programs provide early exposure to a wide range of career possibilities, helping to break down stereotypes and encourage more girls to pursue STEM fields. Given that technology and data-driven roles are often male-dominated, targeted initiatives can help bridge the gender gap and ensure that young women feel supported in pursuing these careers.”

Bridenbaker concurs. “Everything starts at school in terms of cultivating ambition and a sense of what you can achieve,” she says. “When I was at school and passionate about science, I was at times discouraged from pursuing this as a specialist subject and career on the basis that this would be a tough path for a woman and for raising a family; it was suggested instead that being a teacher was more realistic. Actively promoting STEM subjects to girls from an early age is essential to cultivate their passion, talent, and ambition, first so they have a vision and then so that they believe in themselves enough to pursue it.”

For example, a passion for science led Alex Tabbitt, quality control microbiologist at SERB Pharmaceuticals to study biology and chemistry and pursue a degree in forensic investigation. “I think there could be more done to encourage girls through school,” says Tabbitt. “The sciences can be hard and inaccessible, which could be tackled. I was always most engaged by the practical side of my studies—the experiments and the chance to see science in action. Perhaps more could be done to link what is learned in the classroom to its significance in the real world.”

Redmond points to programs like Girls Who Code, which helps girls build coding and AI skills, as gateways for women in healthcare industries. “By increasing representation in STEM fields, these initiatives help drive diversity in leadership and innovation in pharma and biotech,” Redmond says. “Additionally, mentorship, networking, and industry partnerships further support women in transitioning from education to impactful careers.”

Ensuring women have access to grants and jobs in STEM fields requires a ‘multi-faceted approach’ of financial support, mentorship, and changes in cultural norms, asserts Redmond. Having dedicated funding and education opportunities, including internships, for women can increase access to these STEM areas.

“Mentorship plays a key role, and many companies have established internal or external mentorship programs,” says Redmond. “Professional networks play a key role. I have personally benefitted from the incredible network of women from the IQVIA WIN ERG that has lasted over many years, and engaging in these groups can lead to many opportunities such as exposure to networking events, conferences, collaboration, and job opportunities.”

“The pharma industry should absolutely be investing in and promoting STEM career paths for girls,” says Bridenbaker. “It’s incumbent on them to do so. It’s about investing in a sustainable talent base, and about doing the right thing by half of the population. Not to mention accessing the many inherent leadership qualities that women bring to the table, and as drivers of technology-based process innovation.”

Gölden points to the concept of the "leaky pipeline", which describes how women are more likely to leave STEM fields at various stages of their careers, as a factor for the lack of women in these job positions. “From my perspective the leak arises mostly from the challenge of ‘working motherhood’,” says Gölden. “There are already great set-ups as maternity leave, that jobs are held, more and more flexible working models and so on, but it is not yet enough to fully enable mothers to be able to master the work-motherhood challenge.”

While Bridenbaker believes the advancement of women in STEM fields is improving, more could be done. She points to countries, such as the United Kingdom, Ireland, France, and Nordic countries, that actively protect women in the workplace by providing maternity and paternity leave and good work-life balance practices as having a head start in creating, and maintaining, STEM jobs for women. “Without good policies here, economies and employers are putting at risk a significant proportion of their workforce and future talent base, and by extension their long-term sustainability,” she says.

“Creating a supportive workplace is vital, with active promotion, by example,” says Cwienczek. “Also, ensuring a degree of flexibility and allowance for a heathy work-family balance; though, this is not relevant only for STEM fields.”

“In particular for women, a focus on supporting a return to work following maternity leave is a crucial area where women can benefit from support in their careers,” agrees Redmond. “Finally, increasing visibility of successful women in STEM provides role models and helps shift industry norms. Providing remote work, flexible hours, and parental leave options helps retain women in STEM careers.”

 for more coverage on the International Day of Women and Girls in Science.

1. UN. International Day of Women and Girls in Science, 11 February. 

https://www.un.org/en/observances/women-and-girls-in-science-day/

Investing in STEM programs for girls in an education setting and then supporting women as they excel in their professional careers is key to ensuring that vital highly skilled personnel are not left behind. 

Leaving STEM Skills on the Table

BridgeBio Pharma, of Palo Alto, Calif., has announced the European Commission (EC)’s marketing authorization approval for Beyonttra (acoramidis), for treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) (1) in the European Union. In a press release on Feb. 11, 2025, BridgeBio said the treatment is the first to be approved with a label specifying a near-complete (≥90%) transthyretin (TTR) stabilizer.

According to BridgeBio, information published in 

 in December 2024 suggested that relative increases in serum TTR concentrations, as the result of greater TTR stability, are linked to a reduced risk of both all-cause and specific cardiovascular mortality in the general population (1).

A Phase III study (ATTRibute-CM) on which EC based its approval showed the most rapid benefit of any such study of acoramidis to date, BridgeBio said. This included the time to first event—meaning all-cause mortality or cardiovascular-related hospitalization (CVH)—durably separated, relative to placebo, in as few as three months, and up to a 50% reduction in cumulative frequency of CVH events relative to placebo at month 30 (1).

BridgeBio’s acoramidis treatment was previously among five drugs 

recommended for orphan drug status in December 2024

 by the European Medicines Agency’s Committee for Medicinal Products for Human Use as part of the committee’s larger recommendation of 17 drugs for market authorization, also including six biosimilar recommendations (2).

“ATTR-CM is a rapidly progressing disease with a poor prognosis when left untreated, making the approval of acoramidis, which has demonstrated improved benefit on all-cause mortality and cardiovascular-related hospitalizations in as few as three months, a very important accomplishment for patients. We are pleased that people living with ATTR-CM will have access to another treatment option in the EU,” said Marianna Fontana, MD, PhD, professor of cardiology and honorary consultant cardiologist at the National Amyloidosis Centre, Division of Medicine, University College London, in the BridgeBio press release (1).

BridgeBio has been collaborating on acoramidis since March 2024 with Bayer, which will be responsible for all commercial activity for the treatment in the EU, according to the press release (1). With this approval, BridgeBio will receive a $75 million milestone payment from Bayer, and also will be due royalties in a tiered structure.

“The EU approval of acoramidis is a significant advancement for patients living with ATTR-CM in need of new disease-modifying treatments for their condition,” said Jonathan Fox, MD, PhD, BridgeBio cardiorenal chief medical officer, in the release. “This approval would not have been possible without the commitment of the clinical trial participants and their families, and the dedicated support of the physicians and scientists involved in the clinical program. Alongside our able partners at Bayer, we look forward to this new opportunity to serve ATTR-CM patients across the European Union.”

The EC authorization of BridgeBio’s product comes one week short of exactly five years since Pfizer’s Vyndaqel (tafamidis) was 

approved by the same body on Feb. 18, 2020,

 making it the first available treatment for patients with ATTR-CM in the EU (3). In March 2022, AstraZeneca’s Alexion rare disease group 

 with Neuroimmune to develop, manufacture, and commercialize NI006, at the time an investigational treatment for ATTR-CM (4).

Acoramidis will be launched by Bayer in the EU in the first half of 2025 (1). The treatment is currently also under review by both the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency.

1. BridgeBio Pharma. Beyonttra (acoramidis), The First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM. Press Release. Feb. 11, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 9–12 December 2024. Press Release. Dec. 13, 2024.
3. Pfizer. European Commission Approves Vyndaqel, The First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Press Release. Feb. 18, 2020.
4. AstraZeneca and Neurimmune Close Exclusive Global Collaboration and Licence Agreement to Develop and Commercialise NI006. Press Release. March 1, 2022.

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

European Commission Approves BridgeBio Treatment for ATTR-CM

International Day of Women and Girls in Science: Research, Diversity, and AI

 anniversary of the International Day of Women and Girls in Science. 

® sat down with Jean Redmond, Chief Operating Officer at Biologit, to talk about the importance of diversity in research, the unique role women play in the field of artificial intelligence (AI), and what can be done to enrich programs to encourage girls to pursue jobs in science, technology, engineering, and mathematics (STEM).

 AI is a fast-growing technology in the pharmaceutical industry. Are there unique and specific skills and/or viewpoints women in STEM jobs bring to this area?

 I believe AI is set to transform the pharmaceutical industry, and this is already taking place in many real-life use cases. Women in STEM need to be intimately involved in the development and deployment of AI to ensure it is built ethically and representatively and in a fit-for-purpose way for problems that affect women.

Whilst AI is hugely powerful and set to transform the industry, it needs to be understood as a tool first and not a solution out of context. Women in STEM need to provide their input to understand the unique problems and ensure appropriate and impactful application. For example, AI and automation is set to transform the landscape of clinical trials, an area in which women have been historically underrepresented. There is huge scope and opportunity here for women to play a key part in.

In addition, it has long been known that data bias exists in research, and it is important that AI models that may impact healthcare are trained on relevant and diverse datasets. In addition to gender diversity, it is also important to consider racial and age diversity and different stages of life, and ensuring the datasets are comprehensive and representative. Women can play a role in advocating for the ethical development of AI.

 How can access to grants for women scientists and to jobs for women working in STEM fields be increased and/or nurtured?

 Increasing access to grants and job opportunities for women in STEM requires a multi-faceted approach that includes financial support, mentorship, and cultural shifts.

Dedicated funding or grants to support paid industry placements for students, or further education opportunities for women, can increase access to roles in STEM. More financial aid and early exposure to STEM careers through internships can encourage long-term participation. In particular for women, a focus on supporting a return to work following maternity leave is a crucial area where women can benefit from support in their careers.

Mentorship plays a key role, and many companies have established internal or external mentorship programs. Professional networks play a key role. I have personally benefitted from the incredible network of women from the IQVIA WIN ERG that has lasted over many years, and engaging in these groups can lead to many opportunities such as exposure to networking events, conferences, collaboration and job opportunities.

Finally, increasing visibility of successful women in STEM provides role models and helps shift industry norms. Providing remote work, flexible hours, and parental leave options helps retain women in STEM careers.

Jean Redmond, Chief Operating Officer at Biologit

Jean Redmond is Chief Operating Officer at Biologit, a technology company revolutionizing literature monitoring for pharmacovigilance. At Biologit, Redmond oversees operations and lead strategic growth initiatives, leveraging her background in general management, strategy, operations, and scientific research.

Videos

Pharmaceutical Technology® sat down with Jean Redmond, Chief Operating Officer at Biologit, to discuss the use of artificial intelligence in pharmaceutical research and development and the role women play in this fast-developing area.

Feliza Mirasol is the science editor for 

Outsourcing ADCs development manufacturing technology expertise partnerships

A CDMO’s Perspective on Outsourcing Challenges for ADCs–Part 2

®, Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, points out the need for having the right expertise when it comes to developing and manufacturing antibody drug conjugates (ADCs). He points to Lonza’s 

 of the Netherlands-based Synaffix (1), whose technology offers a new way of doing conjugation and closes a technological gap in Lonza’s own repertoire.

“We require this technology because it brings some value to the customer,” Morello says. “[This technology] is something that no one else has.” Synaffix’s technology specifically addresses the challenge of how many linkers and payloads can be connected to the mAb carrier, he explains.

In terms of outsourcing partnerships for ADC development, Morello notes that each ADC program is different, and each company is different. “What is very important is to understand what the company, the ADC developer, the customer, needs. For that, we need to understand what is the clinical development plan? What is the main challenge—is it to be fast? Is it to master a very specific technology? [There] is no ‘one size fits all’,” he says.

Morello also notes that it is more important to have an approach that is customer-specific and program-specific in order to address the developer’s needs. He also emphasizes the importance of capturing the right technologies into one’s toolbox. “In the past, we started out produc[ing] just the conjugation. Now, we are offering a totally integrated solution: we can produce the antibodies; we can produce the drug linker; we can, for sure, produce the bioconjugate [drug] substance—but we can also produce the bioconjugate direct product,” he states.

Christian Morello, Vice President and Head, Bioconjugates Business Unit, Lonza

Christian Morello is vice president and head of the Bioconjugates Business Unit at Lonza. He is responsible for establishing and driving strategy of the business unit developing bioconjugates/antibody-drug conjugate (ADC) manufacturing services for Lonza’s customers worldwide. Prior to joining Lonza, Morello was the head of Global Project Management at Sanofi where he oversaw the development portfolio execution. He is a biochemical engineer and has over 28 years of experience in drug development from discovery to registration, planning, manufacturing, and programs management.

1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023.

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs. 

L.B. Bohle, a Germany-based manufacturer and supplier of processing solutions for pharmaceutical solids, is previewing one of its offerings that will be making its United States debut at INTERPHEX in New York City in April 2025.

A press release on Feb. 10, 2025 said that L.B. Bohle representatives will be giving technical overviews of the company’s QbCon1, which L.B. Bohle describes as a three-in-one module that provides continuous raw material dosing, twin-screw wet granulation, and drying within a compact and mobile design (1). The continuous drying process, which the company has patented for this device, aims to improve product quality, increase flexibility, and enhance operator safety.

Drying capability for pharmaceutical applications, L.B. Bohle said, has typically been limited to semi- or quasi-continuous units, which operate on a per-batch basis (1). To alleviate the inherent problem in this process of filter blocking, QbCon1 employs a novel filter cleaning technique which ultimately permits short residence times for granules in the dryer, traceability of all excipients and active ingredients in a continuous process, uniform and reproducible drying of all particles regardless of size, and lengthened lifespans for exhaust air filters.

L.B. Bohle said that certain tests of QbCon1 showed some processed granules exhibited moisture content below that of the original raw material (1). The system can handle throughputs from 0.5 to 2.5 kilograms per hour—even up to 5 kg per hour for some products—making it versatile either for R&D phases involving very small quantities of APIs or efficient scale-up to commercial-level batches.

Compatibility with data acquisition systems is also available, affording the ability to optimize performance with detailed process insights (1).

Assembly and disassembly of QbCon1, as well as cleaning of the unit with water or detergent solutions, can be performed nearly tool-free, according to L.B. Bohle, in 10 minutes (1).

 Vinay Patil, product development manager at Sharp Services, pointed to advances in granulation, compression, and coating as a few of the factors that have pushed innovation in formulation of drug products forward (2).

“The introduction of high-shear granulators, fluid-bed processors, and roller compaction has enhanced the production of tablets with better mechanical properties and dissolution profiles,” Patil said in the article. “Coating technologies have also advanced, with enteric coatings and controlled-release formulations becoming more common.”

With regard to dryers, the RheaLyo GMP-Flex continuous freeze-dryer +1 2 from RheaVita 

 in the Manufacturing Excellence category at the CPHI Milan conference in October 2024 (3). This dryer was touted as the first continuous freeze-drying system for aseptic good manufacturing practice production.

INTERPHEX will be held from April 1–3, 2025 at the Javits Center in New York City. L.B. Bohle said it is slated to occupy Booth 1519A at the event (1).

®’s coverage of INTERPHEX from 2023 and 2024.

1. L.B. Bohle. At INTERPHEX NYC, L.B. Bohle to Showcase US Debut of Pharma Market’s First Wet Granulator with Integrated, Truly Continuous Dryer. Press Release. Feb. 10, 2025.
2. Haigney, S. Forging Ahead in Formulation. 

 eBook, 2024 September.
3. CPHI. CPHI Excellence in Pharma Award Winners 2024. Press Release. Oct. 8, 2024.

The company says it is the pharmaceutical market’s first wet granulator with an integrated, truly continuous dryer.

L.B. Bohle Wet Granulator to Make US Debut at INTERPHEX

Outsourcing ADCs development manufacturing partnerships

A CDMO’s Perspective on Outsourcing Challenges for ADCs–Part 1

®, Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses three challenges he sees with bringing new antibody-drug conjugates (ADCs) to market. The first challenge is tied in with the overall dynamic of innovation as much of this innovation is coming for small biotech firms, and those companies are not equipped with the internal capacity to produce product. Secondly, there is also a lack of expertise for the industrialization and scale up of ADC manufacturing, and thirdly is the complexity of the supply chain, Morello enumerates.

“[These are] the three main challenges that an ADC developer has to face and has to overcome to make clinical supply, or to make commercial supply,” Morello says. “And this is where a CDMO [contract development and manufacturing organization] [such as] Lonza brings in a lot of benefit.

The science of ADC manufacturing has evolved much over the past 20 years, Morello also emphasizes. There has been much improvement in the technology for making the monoclonal antibody (mAb) component (i.e., carrier) as well as in the linker technology. Therefore, Morello explains, “If you want to go fast, you need to make sure that you have the expertise to take care of your drug and the complexity of the manufacturing as well the experience to scale up and go through the different regulatory paths.”

Morello also points out that an ADC developer is not obliged to build in-house capacity, “because then you can allocate [that] money on the clinical development, [which is where] you will create and validate your concept associated to the development of the drug. So, clearly, when you look at the overall portfolio, 70 to 80% of the ADC portfolio is outsourcing.”

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses the challenges and unmet needs in bringing ADCs to market. 

AstraZeneca has announced that its Lynparza (olaparib) has been accepted within NHS Scotland, that country’s healthcare system, by the Scottish Medicines Consortium (SMC) (1). The approval, according to a Feb. 10, 2025 press release from AstraZeneca, is intended for treatment of adults with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with germline breast cancer genes 1 or 2 (BRCA1, BRCA2) mutations after chemotherapy.

“This is a significant step forward for Scottish breast cancer patients with germline BRCA-mutations,” Tom Keith-Roach, president of AstraZeneca UK, said in the press release. “We look forward to NHS Scotland expanding BRCA gene testing eligibility to this patient group.”

BRCA1 and BRCA2 produce proteins responsible for repairing damaged DNA; when these genes are mutated or altered, AstraZeneca explained in the release, cells may become unstable due to the DNA damage not being able to be repaired (1). Olaparib, according to AstraZeneca, is a product created in the United Kingdom that is a poly-ADP-ribose polymerase (PARP) inhibitor, a targeted cancer therapy that targets PARP in order to disrupt the DNA repair process and potentially kill tumor cells.

Almost 5000 people in Scotland are diagnosed with breast cancer every year, AstraZeneca said, with mutations in the BRCA genes significantly increasing cancer risk—and being found in up to 10% of breast cancer patients (1). Those who carry the mutations have a 50/50 chance of passing them to their children.

SMC’s decision on olaparib was based on positive results from a Phase III trial (OlympiAD) that met its primary endpoint of median progression-free survival, showing that patients treated with olaparib experienced a 42% reduction in risk of disease worsening or death versus those treated with chemotherapy (1). Some of the most common adverse reactions included nausea, anemia, fatigue, and vomiting.

“Metastatic breast cancer is a challenging diagnosis for patients, who have to expect shortened survival, often experiencing low health-related quality of life, and a significant burden from its treatment,” Professor David Cameron, professor of oncology at Edinburgh University and director of Cancer Services at NHS Lothian, said in the press release. “For those women whose breast cancer has arisen on a background of an inherited (germline) alteration in the BRCA1 or BRCA2 genes, olaparib offers patients a treatment option, with data from the OlympiAD Phase III trial, demonstrating a significant delay in cancer progression or death compared to standard chemotherapies, and to do so as a tablet therapy. This recommendation by the SMC represents a significant milestone for patients in Scotland, addressing an unmet need for targeted therapies for those living with BRCA-mutated HER2-negative breast cancer.”

Olaparib was previously approved throughout the European Union in August 2024 in combination with another AstraZeneca product, Imfinzi (durvalumab), for another type of cancer treatment, that of certain people who have primary advanced or recurrent endometrial cancer (2).

AstraZeneca, meanwhile, has continued to make inroads outside the UK early in 2025, announcing in January that it would be creating more than 700 high-skilled jobs in Canada, specifically around the greater Toronto area, as the result of a C$820 million (US$570 million) investment (3).

1. AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025.
2. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
3. AstraZeneca. AstraZeneca Plans C$820 million (US$570m) Investment in Canada to Advance Growing Global Hub and Clinical Delivery. Press Release. Jan. 23, 2025.

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

Scottish Medicines Consortium Accepts AstraZeneca’s Breast Cancer Treatment

 anniversary of the International Day of Women and Girls in Science, recognized on February 11. This day puts a spotlight on gender equality in the fields of science, technology, engineering, and mathematics (STEM). Even though progress has been made with the education of girls in STEM fields, there is still a divide when it comes to representation of women in STEM industries, such as the pharmaceutical industry, despite women being half of the world’s population (1,2). According to the United Nations (UN), only 28% of engineering graduates are women, and there are still challenges for the women who do enter into STEM fields, including sexual harassment and a lack of senior positions for women (1).

A variety of pharmaceutical companies and organizations are celebrating the day in a variety of ways. Sanofi is highlighting five employees the company feels are helping to “pave the way for change in science”: Kasey Boynton, senior director, Global Operations & Partnerships, who works to increase clinical trial access in underserved communities; Amy Brennan, cluster head, Manufacturing & Supply, who is a leader in rare diseases, oncology, and immunology, and optimizes productivity across specialty care sites; Alexandra Hicks, head of Type 2 Immunology Research, who leads research in type 2 inflammation across immune-mediated diseases; Brenda Mulligan, global head of Science and R&D Communications, who works to educate on discoveries in the lab and their impact on patients; and Sandrine Samson, head of Global Vaccine Medical Affairs, New Products & Innovation, who states, "Being part of the family of scientists and using science to help the world be healthier and more equitable is the best part" (3).

Medicines Discovery Catapult (MDC) is also highlighting women in science by featuring some of their collaborators, including Kristy Smitten, leader of MetalloBio, who has won awards for the novel antimicrobial class to combat antimicrobial resistance; Helen McCarthy, CEO and co-founder of pHion, who invented a proprietary cell-targeting drug-delivery peptide; Helen Philippou, founder of LUNAC Therapeutics, who is a researcher on blood coagulation and whose company is developing first-in-class, next-generation intravenous anticoagulants; Kate Cameron, founder of Cytochroma, which manufactures multicellular hepatic and cardiac models; and Donna Finch, head of Translational and Clinical Sciences at Alchemab Therapeutics, which was awarded best-emerging biotech start-up in at the 2021 OBN Awards (4).

Research organization MRIGlobal highlighted scientists Chelsey Smith, whose research has supported development of a massively multiplexed detection (MMD) device for early threat detection, and Alison Hart, whose works have helped develop multiple steps for synthetic routes. “For more than 80 years, MRIGlobal’s scientific research contributions have been advancing knowledge and shaping the world. These are but two of our many scientists who are women whom we celebrate,” the company stated (5).

Yasmine Sherif, executive director of Education Cannot Wait, released a statement on Feb. 11, 2025, saying, “The future of the human race hangs in the balance. With science and technology far outpacing the capacity of most humans to keep up, we must arm our future scientists and future leaders with the knowledge, skills and critical thinking abilities they need to survive and thrive in the brave new world of the 21st century. To achieve these goals, we must empower an entire generation of girls in crises to receive the education, training and resources they need to improve their knowledge and skills base in [STEM]” (6). Sherif specifically pointed out the women and girls living in areas of conflict.

“It is not an easy road. For girls living on the frontlines of armed conflict, climate change and forced displacement, the thought of even attending school is elusive at best. In all, there are now nearly a quarter of a billion crisis-affected girls and boys whose right to a quality education fit for the 21

 century is interrupted by these preventable protracted crises. Girls are among the most vulnerable. Rather than studying science or learning about technology, they are exposed to forced child marriage and unwanted pregnancies without their potentials ever being achieved,” Sherif said in the statement (6).

® will be speaking with several women working in STEM fields to discuss the impact women have in the industry. Our 

, COO of Unbiased Science, is now available (7). 

United Nations. International Day of Women and Girls in Science, 11 February. 

Sanofi. Celebrating Women in Science. Feb. 11, 2025 

https://www.sanofi.com/en/magazine/our-science/celebrating-women-science

MDC. MDC Celebrates International Day of Women and Girls in Science. 

https://md.catapult.org.uk/news/mdc-celebrates-international-day-of-women-and-girls-in-science/

MRIGlobal. Using Science to Improve People’s Lives. Blog Post, 

Education Cannot Wait. International Day of Women and Girls in Science Statement by Education Cannot Wait Executive Director Yasmine Sherif. 

https://www.educationcannotwait.org/news-stories/directors-corner/brave-new-world

Haigney, S. International Day of Women and Girls in Science: Support and Empowerment. 

https://www.pharmtech.com/view/international-day-of-women-and-girls-in-science-support-and-empowerment

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.

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