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Drug Digest December 2025

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A “Plan, Prevent, Prove” Approach

Pamela James, PhD, is vice-president, Product, Vector Laboratories.

In the continued quest for truly personalized medicine, biomarker discovery has expanded far beyond genomics and proteomics. Scientists are increasingly interested in glycans, the carbohydrates that link to proteins and lipids in a process known as glycosylation. Glycosylation is a fundamental regulator of countless biological activities, including immune cell function in health and disease. Research seeking to characterize dysregulated glycosylation and its effects on immune regulation will be vital to the development of new diagnostics and therapeutics. Despite progress in recent years, research has only begun to scratch the surface of this broad topic.

Glycosylation analysis can provide a deeper and more nuanced understanding of immune cell function, going beyond typical biomarkers to establish more detailed phenotypic subcategories of B and T cells and offer insight into disease etiology and progression. The continued study of immune cell glycosylation will undoubtedly drive progress in the identification of methods for early detection and characterization of disease states. However, further advances in analytical technology will be instrumental in helping this field reach its full potential.

The diverse assortment of cell surface glycans, known collectively as the glycome, offers a rich and dynamic tapestry of insights into biological processes. Glycosylation is a ubiquitous post-translational modification (PTM), with approximately 50–70% of all proteins bearing glycans (1). As cell types, including immune cells, become more extensively characterized and subdivided into categories based on biomarkers, glycosylation status has become an increasingly important variable within these analyses. Glycosylation is incredibly dynamic—unlike proteins, the structures of glycans are not coded by a set genetic template. Rather, it is regulated by the milieu of enzymes surrounding the glycoform, meaning that the population of glycans found on any given cell is highly diverse and constantly changing (2). This dynamic diversity, coupled with the powerful role of glycans in regulating downstream functions, means that the glycosylation profile of a cell may provide a deeper insight into real-time functionality than biomarker expression can.

Interactions between glycans and glycan-binding proteins play a vital role in controlling and fine-tuning immune cell development, activation, and function. For example, the presence of specific O-glycan modifications to P-selectin binding ligands dictates the migration of T cell precursors to the thymus. Further glycosylation also mediates the maturation of thymocytes into CD4+ and CD8+ T cells (3). O-glycan remodeling is also an important feature of B cell development, such that distinct glycoforms can serve as markers of different phases of differentiation (4).

The glycan signatures on healthy, dysregulated, or malignant cells, as well as those on pathogens, serve as signals for immune recognition of “self” vs. “other.” The glycome is thus indispensable in regulating immunity vs. tolerance. Changes in immune cell glycosylation are a useful indicator of the cells’ activity throughout cell differentiation, activation, and apoptosis that can be used to characterize subsets of B and T cells in various disease states. These alterations have been associated with various immune cell functions, such as immune cell trafficking, antigen and cytokine receptor activation, cellular signaling, and more.

For example, glycosylation plays a key role in modulating tumor immunogenicity and immune evasion. Tumor cells secrete galectins that can bind to glycans present on effector T cells and attenuate their activity, leading to an immunosuppressive effect. Specific tumor-associated galectins restrain T cell activation, limit cytokine production, or even induce apoptosis (5). Growing evidence also implicates dysregulated glycosylation in autoimmunity. One study examined B cell markers in samples from individuals with primary Sjögren’s syndrome and systemic lupus erythematosus, two chronic autoimmune conditions (6). Researchers discovered notable changes in glycosylation within specific B cell subsets that were altered in both diseases, as well as similar alterations in certain serum immunoglobulins. These and other findings suggest that any dysfunction in normal B and T cell glycosylation can result in the development of pathogenic autoinflammation and contribute to a general perturbation of immune system homeostasis (7).

Lectin-based flow cytometry is among the most important tools for profiling glycosylation in heterogeneous cell populations. Using fluorophore-conjugated lectins that bind to specific glycan structures, researchers can analyze and quantify glycans present throughout a sample of cells in suspension. Flow cytometry offers a number of advantages that make it ideal for profiling immune cell glycosylation, including its high throughput. Researchers can quickly analyze hundreds of thousands of cells for multiple glycan biomarkers within phenotypic subsets identified by more traditional surface markers. Flow cytometry is ideal for assessing liquid samples such as serum; cells extracted from tissue samples such as the thymus, spleen, and lymph nodes; or bone marrow. However, the nature of the flow cytometry method precludes the ability to gain useful spatial information about the distribution of glycans in solid tumors or tissues using this method alone.

Nonetheless, using flow cytometry to profile glycosylation can still help healthcare providers and researchers characterize important immune mechanisms in hematological malignancies. An example of the utility of flow cytometry was shown in a 2023 study that assessed glycan markers on leukocytes in patients with myelodysplastic neoplasms (MDS) (8). MDS are age-related disorders of white blood cell overproliferation, the course of which can range from relatively benign conditions to acute myeloid leukemia (AML). In the study, the researchers identified distinct glycosylation profiles associated with cell maturation and lineage differentiation. They also characterized unique cellular glycosignatures associated with disease course, differentiating low-risk MDS from AML. These findings suggest that lectin-based flow cytometry of leukocytes could be used to identify distinct glycosylation profiles for MDS risk stratification.

Liquid chromatography and mass spectrometry are two methods used separately and in tandem to characterize glycans on a more specific level. Liquid chromatography separates distinct compounds contained within a liquid sample by running it through a solid column. The different components within the sample are then separated based on their speed passing through the column. Mass spectrometry measures the mass-to-charge ratio of ions in an analyte of interest to create a mass spectrum that can be used to determine the mass or chemical composition of the analytes.

When used together, liquid chromatography–mass spectrometry (LC–MS) allows researchers to separate and identify the components of a complex biological mixture. This combination is particularly useful in instances where liquid chromatography would not provide sufficient resolution or when analyte masses would overlap when assessed with mass spectrometry alone. Liquid chromatography, mass spectrometry, and LC–MS are valuable methods for profiling immune cell glycosylation in many applications.

Researchers have leveraged liquid chromatography and mass spectrometry to examine the relationship between immunoglobulin glycosylation status and aging, cancer, autoimmune disorders, and more. A 2020 study of inflammatory biomarkers in multiple sclerosis used hydrophilic interaction liquid chromatography with mass spectrometry to characterize glycans on immunoglobulin G (IgG) (9). When comparing serum IgG from multiple sclerosis patients to age- and sex-matched controls, the researchers identified significant differences in four of 24 measured IgG glycan traits. Additionally, the specific structural alterations observed in IgG glycans were associated with increased proinflammatory potential, suggesting the utility of glycomic changes as possible biomarkers in multiple sclerosis. The results of this study illustrate the ability of LC–MS to provide detailed structural information about glycans in a sample.

Another approach to simultaneously analyzing multiple glycan biomarkers is through lectin microarrays, which use a panel of assorted lectins immobilized on a substrate. By incubating a fluorescently tagged liquid sample with the panel, researchers can use fluorescence detection to assess binding events and thus characterize the glycans present in the sample. Lectin microarrays offer a number of benefits, including relative technical simplicity and high specificity for glycoforms. Additionally, while LC–MS analysis often requires the chemical or enzymatic release of glycans from associated proteins, lectin microarrays can be used to study intact glycans without a demanding sample preparation process (10). However, this method is not quantitative and precludes the complete determination of glycan structures allowed by mass spectrometry.

Lectin microarrays are utilized in a variety of research applications, including biomarker discovery. They are especially promising for studies of immune cell glycosylation, as they allow researchers to observe lectin binding to intact glycoforms rather than separated glycans. For example, one study leveraged lectin microarrays to identify changes in serum immunoglobulin glycosylation in hepatocellular carcinoma (11). Researchers used these findings to construct a model that could distinguish diagnostic markers of hepatocellular carcinoma from other hepatic diseases and healthy controls, potentially improving diagnostic accuracy for the disease.

While glycomics research has gained momentum in recent years, the field still has a way to go in developing tools and methods for fully characterizing and understanding the implications of glycosylation in health and disease. Several well-established approaches are available to characterize glycans present within a sample or on a specific subset of cells. However, most current methods preclude a higher level of resolution that can identify distinct glycans on specific proteins. Advances in methods such as proximity labeling, which can identify biomolecules close to a protein of interest, are beginning to surmount these limitations. Researchers can tag glycan-protein interactions present on cells for later enrichment and analysis using mass spectrometry-based proteomics. Proximity labeling can also be used in conjunction with flow cytometry to characterize select glycan–protein interactions on intact cells (12).

Further innovation and research are needed to establish a more complete understanding of protein-specific glycosylation patterns. As technological developments continue to expand scientists’ understanding of the role of cell- and protein-specific glycosylation in health and disease, these discoveries could be leveraged to identify more precise and relevant biomarkers and therapies than ever before.

1. Apweiler, R.; Hermjakob, H.; Sharon, N. On the Frequency of Protein Glycosylation, as Deduced from Analysis of the SWISS-PROT Database. 

Biochimica et Biophysica Acta (BBA)-General Subjects

 (1), 4–8. DOI: 10.1016/S0304-4165(99)00165-8
2. An, H. J.; Froehlich, J. W.; Lebrilla, C. Determination of Glycosylation Sites and Site-Specific Heterogeneity in Glycoproteins. 

 (4), 421–426.
3. De Bousser, E.; Meuris, L.; Callewaert, N.; Festjens, N. Human T-cell Glycosylation and Implications on Immune Therapy for Cancer. 

 (10), 2374–2388. DOI: 10.1080/21645515.2020.1730658
4. Giovannone, N.; Antonopoulos, A.; Liang, J.; et al. Human B Cell Differentiation Is Characterized by Progressive Remodeling of O-Linked Glycans. 

, 2857. DOI: 10.3389/fimmu.2018.02857
5. Nardy, A. F.; Freire-de-Lima, L.; Freire-de-Lima, C. G.; Morrot, A. The Sweet Side of Immune Evasion: Role of Glycans in the Mechanisms of Cancer Progression. 

, 54. DOI: 10.3389/fonc.2016.00054
6. Morel, M.; Pochard, P.; Echchih, W.; et al. Abnormal B Cell Glycosylation in Autoimmunity: A New Potential Treatment Strategy. 

, 975963. DOI: 10.3389/fimmu.2022.975963
7. Ramos-Martínez, I.; Ramos-Martínez, E.; Cerbón, M.; et al. The Role of B Cell and T Cell Glycosylation in Systemic Lupus Erythematosus. 

 (1), 863. DOI: 10.3390/ijms24010863
8. van Spronsen, M. F.; Horrevorts, S.; Cali, C.; et al. Dysregulation of Developmental and Cell Type-Specific Expression of Glycoconjugates on Hematopoietic Cells: A New Characteristic of Myelodysplastic Neoplasms (MDS). 

 (3), 702–707. DOI: 10.1038/s41375-022-01784-x
9. Cvetko, A.; Kifer, D.; Gornik, O.; et al. Glycosylation Alterations in Multiple Sclerosis Show Increased Proinflammatory Potential. 

 (10), 410. DOI: 10.3390/biomedicines8100410
10. Dang, K.; Zhang, W.; Jiang, S.; Lin, X.; Qian, A. Application of Lectin Microarrays for Biomarker Discovery. 

 (3), 285–300. DOI: 10.1002/open.201900326
11. Zhang, Y.; Zhang, S.; Liu, J.; et al. Identification of Serum Glycobiomarkers for Hepatocellular Carcinoma Using Lectin Microarrays. 

, 973993. DOI: 10.3389/fimmu.2022.973993
12. Vilen, Z.; Joeh, E.; Critcher, M.; Parker, C. G.; Huang, M. L. Proximity Tagging Identifies the Glycan-Mediated Glycoprotein Interactors of Galectin-1 in Muscle Stem Cells. 

 (10), 1994–2003. DOI: 10.1021/acschembio.1c00313.

Articles

Capturing the nuances of immune cell phenotype and function can be achieved using glycosylation analysis. 

Using Glycobiology to Study the Nuances of Immune Cells

Feliza Mirasol is the science editor for 

® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, points out certain redesign concepts that are critical for switching from batch manufacturing to continuous manufacturing.

One key critical concept involves quality by design (QbD), in which a systematic approach is used in pharmaceutical development that focuses on designing quality into the product from the beginning, she says. “It includes defining critical quality attributes, identifying critical material attributes, [and] critical process parameters using their risk assessment and experimentation to understand and control manufacturing processes,” Fathollahi emphasizes.

Fathollahi goes on to explain that one big benefit of the QbD approach is that it helps manufacturers to better understand the correlation between raw materials, the process, and the quality of the final drug product. “This is important, as it supports robust and consistent production in a continuous manufacturing environment,” she explains.

“Embracing quality by design supports manufacturers in designing processes [such] that they are able to compensate variation seen in raw materials without compromising on quality, stability, and functionality of the final drug product,” Fathollahi concludes.

Fathollahi was featured as a speaker at AAPS PharmSci 360 where she gave her talk, “

Impact of Raw Materials Variation On Continuous Feeders Performance

.” Her presentation centered around gaining a better understanding of the natural batch-to-batch variability of raw materials; understanding the link between raw material variation and the manufacturing process; understanding which variation is present in a given raw material and what that specific variation means for the manufacturing process; assessing the risk of using raw materials (with their natural variation) on process robustness and consistency of the final product; and understanding how to derisk the use of excipients in continuous manufacturing processes.

AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.

excipient suppliers supporting continuous manufacturing adoption

Sara Fathollahi, PhD, product application specialist at DFE Pharma, points out important redesign concepts critical to adapting continuous manufacturing.

Redesign Concepts Critical for Continuous Manufacturing (AAPS PharmSci 360)

The American Association of Pharmaceutical Scientists (AAPS) announced results on Oct. 30, 2023 from its 2023 Salary Survey, which showed that salaries for those employed in the pharmaceutical sciences within the United States saw a compensation increase of 6.7% since 2022.

AAPS specified in a press release that the mean annual base salary earned by those employed full-time in the US as of June 1, 2023, was $190,100. Data from the US Bureau of Labor Statistics, in comparison, shows that compensation rose 4.5% across all industries from June 2022 to June 2023.

“It is refreshing to see that salaries continue to rise in pharmaceutical science despite a challenging year in the biotech sector,” said 2023 AAPS President Patrick J. Sinko, in the press release. “Pharmaceutical science is resilient in the face of layoffs, picked up M&A [merger and acquisition] activity, and reduced venture funding. While we are all facing this disruption, the industry still needs scientists to advance the capacity of pharmaceutical scientists to develop products and therapies that improve global health, which is also AAPS’ mission.”

According to the organization, the AAPS Salary Survey is the only survey that exclusively tracks compensation data within the pharmaceutical science sector. The organization surveys its membership each year about salary and compensation information and collects demographic data. The survey collects base salary information and supplemental income, including bonuses, summer-time work, grants, summer teaching, and others. The survey also collects information about income from other professional work, such as consulting, and salaries outside the US. The data are broken down by education level, years of experience, and career field (industry or academia).

A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022. 

Salary Survey for Pharma Scientists Shows Increase of 6.7% Since 2022

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

  see a confident bio/pharma industry ready for the new year and looking to merge technology platforms for emerging opportunities. 

CPHI Barcelona ran from Oct. 24–26, 2023.

CPHI Barcelona has strong showing as bio/pharma industry moves confidently into 2024.

Bio/Pharma Industry Has Strong Showing at CPHI 2023 (Barcelona)

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On Oct. 20, 2023 Pfizer announced that PENBRAYA, its vaccine for meningococcal groups A, B, C, W, and Y, has been approved by FDA. According to Pfizer, PENBRAYA is the first and only vaccine to protect against the five most common serogroups that cause meningococcal disease in patients aged 10 through 25. PENBRAYA combines components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine). It is administered as a two-dose series given six months apart.

Meningococcal disease is an uncommon but serious illness that can be fatal within 24 hours or cause significant long-term disabilities for survivors. PENBRAYA reduces the number of doses to fully vaccinate individuals against the five most common serotypes of the disease, which Pfizer hopes can increase the number of adolescents and young adults vaccinated. This is substantiated by a report from the US Centers for Disease Control and Prevention (CDC), which stated that combining vaccines into fewer shots could mean a higher rate of adolescents and young adults getting vaccinated on time.

The FDA approval was based on data from Phase II and Phase III trials, which included a randomized, actively controlled, and observer-blinded Phase III trial. The trials assessed the safety and efficacy of PENBRAYA in comparison to current US-licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase III trial evaluated more than 2400 patients from the United States and Europe.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

On Oct 24, 2023 FDA approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment of adults with “relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.” Ivosidenib is the first targeted therapy approved for this indication. Abbott Laboratories’ RealTime IDH1 was also approved as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.

MDS are a rare form of blood cancers that develop when mutations in bone marrow progenitor cells (cells that form blood) cause inadequate numbers of healthy blood cells. Approximately 60,000 to 170,000 people in the United States suffer from MDS, and about 87,000 new cases are reported each year worldwide. Around 3.6% of MDS patients have an IDH1 mutation.

This new indication is based on an open-label, single-arm, multicenter study of 18 adult patients with relapsed or refractory MDS with an IDH1 mutation. The mutations were found in peripheral blood or bone marrow via a local or central diagnostic test and were later confirmed with the Abbott RealTime IDH1 Assay. The complete or partial remission rate was 39% (7/18), and of the patients who achieved a complete remission, the average time to complete remission was 1.9 months. Of the nine patients who relied on blood or platelet transfusions, six no longer required transfusions after treatment with ivosidenib.

Ivosidenib was previously approved for select adults with freshly diagnosed acute myeloid leukemia (AML), relapsed or refractory AML, and locally advanced or metastatic cholangiocarcinoma. The Abbott RealTime IDH1 was also approved as a companion diagnostic to identify AML patients with an IDH1 mutation for treatment with ivosidenib or Rezlidhia (olutasidenib). Ivosidenib was granted Priority Review designation, under which FDA is prepared to act on an application within six months of the agency determining that the drug would substantially improve the safety or efficacy of treating, diagnosing, or preventing a serious condition. Ivosidenib also received FDA Breakthrough Therapy designation and Orphan Drug designation.

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

FDA Approves Novel Therapy for Rare Form of Blood Cancers

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On Oct 26, 2023 a report was released from CPHI Barcelona on the discussion around the growth of contract manufacturing organizations (CMOs) in the biologics sphere. The biologics demand is anticipated to reach 4400KL by 2027 (2500KL more than in 2022), which accounts for a growth rate of 11.5% each year and a capacity increase to 8400KL. Tara Dougal, Content Director–Pharma at Informa said, “we see this first hand at CPHI Barcelona where demand for bio CMDOs [contract development and manufacturing organizations] and outsourced biological services continue to grow, and we expect this to be one of the fastest areas of growth in the next few years.”

A CPHI panel of experts—chiefly Dawn Ecker, managing director of bioTRAK Database Services and Patricia Seymour, managing director, BioProcess Technology Group—provided analysis. The panel predicted that even with surprise blockbuster approvals like Wegovy, CMO capacity should be accessible for most biotechs in the coming year. But with CMO capacity growing from 35% of available reactors to 45% by 2027, demand could become constrained in the future as more and more biologics commercialize. Ecker noted that resources could tighten considerably if approvals pass for large population diseases such as Alzheimer’s and diabetes, or if cancer checkpoint inhibitors receive approval from regulators and reimbursement by most insurers. “In this instance, demand for capacity could be much higher resulting in capacity constraints particularly for smaller and early-stage biotech innovators,” Ecker commented.

As of the publication of this article, the majority of cell culture capacity is in-house, primarily concentrated within just 10 companies. This capacity, at 54% in 2023, is expected to rise to 57% in 2027. But as CMOs Fujifilm Diosynth and Celltrion make substantial capacity investments, they are predicted to displace two Big Pharma companies in that top 10 (Novartis and Sanofi). Future manufacturing equipment is also changing and becoming smaller—nearly three quarters of recombinant products in late-phase development can currently be produced using a single 2000L or 5000L bioreactor.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.

CPHI Barcelona: CMOs Expected to Account for 45% Available Bio Capacity in 2027

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On Oct. 25, 2023, the winners of the 2023 CPHI Pharma Awards were announced at the 

 event. The awards are given out for outstanding achievements and contributions to the pharma industry in 12 categories. This year’s winners include:

CEO of Procos, Enrico Zodio, won CEO of the Year as recognition for the company’s development and growth, which exceeds €200 million and includes capacity to further increase production.

Snapdragon Chemistry (a Cambrex company) topped the API Development & Innovation category for its ultra-high temperature (>300 °C) continuous flow manufacturing process for racemization of sotorsib (LUMAKRASTM) P-dione, which harnessed greener technology that resulted in a 58% reduction of process mass intensity.

Lubrizol Life Science Health took home the prize in the Finished Formulation category for its solubility-enhancing excipient designed for parenteral use. Apisolex is a poly(amino acid)-based excipient that provides formulators with methods to enhance the solubility of hydrophobic BCS Class II and IV APIs, by up to 50,000-fold.

The Manufacturing Excellence category went to Luminary Therapeutics for its manufacturing platform, Gamma Delta 2.0+, that brings allogeneic cell therapies to market for less than 10,000 without sacrificing function.

Gasporox took the honors in the Packaging & Machinery section for its AutoMAP Pharma gas measurement system for high or low concentrations of O2 in modified atmosphere packaging.

Catalent won the Supply Chain Excellence category for its Case Management Services, which provides end-to-end supply chain management for autologous and allogeneic cell and gene therapies.

The Regulatory Compliance category went to Lambda Therapeutic Research for their EDC solution that enhances research and data management. The software suite, including IMPTrack, KnowledgeNET, and Biolyte, enables real-time, accurate data capture through advanced functionalities like barcode scanning and retina-based verification. It also manages and retrieves study-related data to improve compliance with regulatory guidelines.

Medicsen took the Drug Delivery & Device Innovation category for its SMARTPATCH. The wearable patch uses ultrasounds to deliver drugs subcutaneously and combines the main benefits of current patch pumps with the upside of eliminating invasive and painful components.

The Accelerating Innovation category went to React4Life’s MIVO (Multi In Vitro Organ), a patented organ-on-a-chip that can host and culture 3D human biological cells or tissues under fluid dynamic conditions as 

Schneider Electric won the Sustainability category for its Energize program. The program leverages the scale of the global supply chain in a pre-competitive fashion to drive system-level change. 

The new Start-Up Initiative category went to InSyBio for its ability to revolutionize the medical ﬁeld, clinical trials, and food/nutrition industries through its targeted biomarker discovery. The company’s highly accurate predictive analytics enables personalization of tests for drugs, nutraceuticals, and nutrition products.

The ‘Heart of Pharma’ award, also new this year, went to Merck KGaA for its Embracing Carers initiative that recognizes the role of family carers.

“CPHI aims to position itself at the ‘heart of pharma’ by creating an environment where everyone in our industry can come together to exchange ideas and build productive new alliances for the ultimate benefit of patients. I whole-heartedly congratulate all winners of this 20th edition of the CPHI Pharma Awards. Those committed to driving innovation across the key disciplines that shape the success of our industry. I’d also like to thank all those who submitted an entry this year, and the members of our jury who so diligently reviewed them,” commented Tara Dougal, Content Director–Pharma at Informa Markets, in a press release.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

Winners of the 2023 CPHI Pharma Awards Announced

At an AAPS PharmSci 360 press briefing on Oct. 24, 2023, Roquette announced the completion of its acquisition of Qualicaps, a manufacturer of hard capsules and pharmaceutical-related equipment, from the Mitsubishi Chemical Group. The acquisition represents a strategic investment by Roquette that is aimed at expanding the global footprint of its pharmaceutical business as well as enrich the company’s offerings of oral dosage solutions.

Through the acquisition, Roquette’s expertise in developing pharmaceutical excipients will be further enhanced by Qualicaps’ expertise in capsules and its assets and infrastructure. The newly combined business will offer diverse solutions with a full range of hard and soft capsules, fillers and binders, disintegrants, and other solutions, according to a company press release.

Qualicaps' global footprint is deemed an important asset for Roquette with manufacturing and R&D sites in Japan, Spain, Romania, Canada, the United States, and Brazil, which will allow Roquette to expand its global presence. The combined company will also provide technical capabilities through a single point of contact for the expanded offering, which Roquette expects will provide customers with improved of service and access to a stronger technical base for the development of future solutions and innovations.

“If we look at the talent, technique, and know-how of both companies, and we synergistically join them together, we can do better innovations, and we can serve our customers better. Qualicaps is strong in Japan as well as in Eastern Europe and North America, whereas Roquette is local. We are strong in Western Europe and in other countries in Asia outside of Japan, and we are making a presence in Eastern Europe,” said Rajeev D. Gokhale, global vice-president—Licensing Technology, Open Innovation and M&A, Roquette, in the press briefing.

AAPS PhamSci 360 runs Oct. 22–25, 2023 in Orlando, Fl.

The acquisition of Qualicaps reflects a strategic investment that aims to strengthen Roquette’s global standing in oral dosage solutions.

Roquette Announces Completion of Qualicaps Acquisition at AAPS PharmSci 360 

The European Medicines Agency (EMA) announced on Oct. 24, 2023 that its Medicines Shortages Steering Group (MSSG) has developed a voluntary solidarity mechanism that allows European Union Members States to support each other during drug shortages. The mechanism was based on a plan set up during the COVID-19 pandemic and can only be used under limited conditions. It is a last resort to be used after Member States have exhausted other possibilities.

EU Member States may request assistance in obtaining medicine stocks from other member states if they face a critical shortage that has been escalated to the MSSG for coordination at European level. The mechanism is part of other shortages actions the MSSG can carry out and is part of the MSSG Toolkit, which includes recommendations for monitoring drug supplies. The mechanism and toolkit are part of actions the European Commission is taking to protect the EU from drug shortages.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

Featured Content

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

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach