Top 10 BioPharm International Articles of 2025

Our top 10 articles for the year reflect a dynamic industry landscape defined by global policy shifts, intense focus on manufacturing quality and efficiency, and strategic partnerships driven by the rise of novel therapeutic modalities. A major theme in 2025 was regulatory and policy actions, such as FDA scrutiny resulting in warning letters and clinical holds for non-compliance with current good manufacturing practice (cGMP), alongside US political demands affecting pharmaceutical pricing (most favored nation [MFN]) and domestic manufacturing expansion in response to potential tariffs. Manufacturing innovation was another significant thread, emphasizing the shift toward efficiency and quality improvement through robust contamination control strategies in cleanrooms, wider adoption of single-use technologies (SUTs) and automation in upstream and downstream processing, and a growing focus on sustainability. These top 10 articles demonstrate the critical importance of outsourcing and collaboration, with major contract manufacturing deals and partnerships (e.g., Samsung Biologics, Lonza, Shilpa Biologicals) being formed to accelerate development and commercialize complex, next-generation drugs, such as immuno-oncology assets and intranasal biologics.

Following is a closer look at each of the top 10 articles.

1. Lilly Statement: MFN Pricing Targeted for September 1, Pushback on Pharma Tariffs

In August, Eli Lilly and Company publicly responded to the Trump administration’s directive demanding pharmaceutical companies lower prescription drug costs for US patients by offering the lowest price available in other developed nations, known as the MFN price. Lilly stated it expected to implement necessary pricing adjustments by September 1, 2025, and supports the administration's goal of maintaining the US as the leader in biopharmaceutical research and manufacturing. However, the company strongly opposes broad tariffs on pharmaceutical products, including its own medicines, warning that such measures would increase costs, restrict patient access, and undermine American leadership, urging instead for strategic incentives for domestic manufacturing.

2. Novel Modalities Spur Shift in Outsourcing Processes and Partnerships

This article from our May 2025 issue explains that the continuous evolution of the bio/pharmaceutical industry, driven by novel treatment modalities like biologics, cell and gene therapies, and peptides, is intensifying the growth of the outsourcing market and transforming the relationship between sponsor companies and contract development and manufacturing organizations (CDMOs). Due to the specialized knowledge and capital investment required for these diverse technologies, sponsor companies are increasingly viewing CDMOs not merely as tactical capacity providers but as essential strategic partners offering technical and scientific expertise. The industry trend favors customized and modular services that accelerate products to the clinical stage and market, with clients often seeking CDMO partners who can integrate and co-locate manufacturing, packaging, and testing to simplify and de-risk the supply chain.

3. Shilpa Biologicals Partners with mAbTree Biologics to Develop and Commercialize a Novel Immuno-Oncology Asset

Shilpa Biologicals, a subsidiary of Shilpa Medicare Limited, announced in March that it had entered into a strategic partnership with Switzerland-based mAbTree Biologics to co-develop and commercialize a novel biologic asset: a checkpoint inhibitor intended for immuno-oncology applications. Under the agreement, Shilpa Biologicals will provide full-service capabilities, including clinical development support and long-term GMP commercial supply for the fully human monoclonal antibody, or mAb, which targets a novel immune checkpoint protein designed to activate T-cells against tumors. The goal of this asset is to enable greater access to medicines and holds therapeutic potential across various cancers, including the ability to convert immunologically "cold" tumors into "hot" tumors.

4. Lonza Partners with Iconovo to Formulate and Develop an Intranasal Biologic

In January, Lonza and Iconovo, a Swedish company specializing in dry powder formulations and inhalers, established a collaboration focused on developing spray-dried formulations for an intranasally delivered biologic. This partnership will involve Lonza developing the formulations using a reformulated drug candidate for obesity at its Bend, Oregon site, leveraging its expertise in bioavailability enhancement and particle engineering. The biologic will be administered via Iconovo’s proprietary nasal device, ICOone Nasal, aligning with Iconovo’s objective to replace traditional oral or injection treatments with patient-friendly inhalation methods.

5. Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part I: Facility and Cleanroom Cleaning Practices

This article from our June issue focuses on the necessity of quality improvement in facility and cleanroom cleaning practices within biopharmaceutical manufacturing, emphasizing that a robust contamination control strategy is essential for ensuring product purity and patient safety. Cleaning and disinfection of manufacturing area surfaces, along with cleaning validation of product contact surfaces, are integral to controlling microbiological contamination. Because many biopharmaceuticals require aseptic manufacturing, adequate cleaning and decontamination in compliance with good manufacturing practices (GMPs) is still required for the manufacturing space, even with containment or barrier systems. Cleaning is intended as the crucial first step to remove residues (such as environmental particles or soils) that could negatively affect the efficacy of subsequently applied disinfectants.

6. Time-to-Market Pressures Are Influencing Downstream Processing Innovations

Driven by pressures to reduce manufacturing costs and accelerate time-to-market, innovation in downstream processing (DSP) is focused on increasing efficiency and scalability while accommodating the complexity of novel modalities, according to this article from our July/August issue. A key trend is the implementation of automation, continuous processing, and process analytical technology to achieve improved consistency, data integrity, and operational efficiency. DSP technologies must specifically evolve to handle complex biomolecules like adeno-associated viral vectors, which require robust viral clearance strategies. Advanced computing technologies, such as mechanistic modeling and digital twins, are playing a critical role in enhancing DSP by allowing for predictive simulations and real-time process control, particularly in complex unit operations like chromatography.

7. FDA Issues Warning to Sanofi About API CGMP Deviations, Puts Clinical Hold on Atara Immunotherapies

In January, FDA took two distinct regulatory actions: the issuance of a warning letter to Sanofi regarding "significant deviations" from cGMP for APIs at its Framingham, Mass., facility, and the placement of a clinical hold on active investigational new drug applications by Atara Biotherapeutics. The warning letter to Sanofi stemmed from inspections conducted in mid-2024, noting that failure to address these deviations could result in further regulatory action, and FDA estimated that approximately 20% of bioreactor runs attempted at the facility between January 2022 and July 2024 were rejected for quality failures, including contamination. The clinical hold on Atara’s Ebvallo was directly related to inadequately addressed GMP compliance issues previously identified in a pre-license inspection at a third-party manufacturing facility.

8. Samsung Biologics Inks More Than $1.4 Billion Manufacturing Deal with European Pharma Company

Samsung Biologics announced in January a contract manufacturing agreement exceeding $1.4 billion with an undisclosed European pharmaceutical company, with production slated to run through December 2030 at its Songdo, South Korea, manufacturing site. The company concurrently highlighted significant updates for 2025, including the scheduled April completion of its fifth biomanufacturing plant and new Bio Campus II, which will increase total capacity to 784,000 L. Samsung Biologics is also expanding its offerings to support antibody-drug conjugates and is investing heavily in digital transformation, intending to incorporate AI and digital twin technology to maximize operational efficiency.

9. Single Use and Sustainability in Upstream Processing

This article from our April issue explores the relationship between single-use technologies (SUTs) and sustainability goals in biomanufacturing, noting that the adoption of SUTs and single-use systems proliferated in the 2010s. Key advantages of SUTs in upstream processing include process closure, which lowers risk and can cut capital expenditures, operating expenses, and CO₂ emissions, as well as inherent water savings because they eliminate the need for cleaning, sanitizing, and sterilizing permanent systems. A life cycle assessment comparing an SUT facility to a conventional stainless-steel facility found SUT implementation reduced energy consumption by 25% and water usage by 28%. While SUTs bring significant benefits, the challenge of managing plastic waste streams is a current industry priority, leading to efforts to optimize use and find circular solutions.

10. Lilly Plans New US Pharmaceutical Manufacturing Sites in Wake of Trump Tariffs

Global pharmaceutical manufacturer Eli Lilly and Company announced in February plans to construct four new domestic manufacturing sites in the US shortly after President Donald Trump revealed intentions to impose steep tariffs on imports from Canada, Mexico, and China. CEO David A. Ricks indicated that the expansion was spurred by incentives from the 2017 Tax Cuts and Jobs Act, provided that the policy is extended. The company’s total domestic capital expansion commitments since 2020 exceeded $50 billion at the time. Three of the new sites will focus on API manufacturing, strengthening chemical synthesis capability and the supply chain, while the fourth is planned to extend Lilly’s global parenteral manufacturing network for future injectable therapies.