Kurt Nielsen, Ph.D., talks with Dan Smithey, Ph.D., CEO of Serán Bioscience, about oral drug innovation, large language models, complexity, and how flexibility can create new pathways to reach market quickly.

Bobby Sheng, Group CEO & Chairman of Bora Pharmaceuticals, discusses his vision for building a world-class CDMO focused on reliable global supply. Sheng's strategy centers on fostering a strong, quality-driven culture within Bora, which he believes is crucial for growth. He highlights the increasing demand for outsourcing in the biopharmaceutical industry, driven by biotech companies needing to overcome time and capital constraints.

Adare Pharma Solutions CEO Tom Sellig reaffirmed the critical role of small molecules in modern medicine and highlighted the company's innovative approach to oral solid dose (OSD) development. Sellig noted the growing trend of transitioning from injectable to oral solid forms, particularly for drugs like GLP-1s, and emphasized the continued dominance of small molecules in addressing various therapeutic needs, including CNS and oncology.

Samsung Biologics has signed a USD 1.4 bn contract with an undisclosed European pharmaceutical company, involving the manufacturing of a biomedicine at its Songdo, Korea, facilities from late 2024 through 2030. As a result of the contract, the company now collaborates with 17 of the world’s top 20 pharmaceutical firms.

The U.S. government has awarded Moderna USD 590 mn to advance its mRNA-based avian influenza vaccine, mRNA-1018, into late-stage clinical trials amid rising human H5N1 infections. The funding also supports clinical studies for up to five additional pandemic influenza subtypes.

Two Australian CDMOs, BioCina and NovaCina, have announced a strategic merger to operate as a single contract manufacturing company under the BioCina name.

Indian CDMO, Aragen, has secured a USD 100 mn investment from Singapore-based private equity firm Quadria Capital to enhance the company's capacity and multi-modality services - including the expansion of its infrastructure and capabilities in areas such as oligonucleotides, peptides, ADCs, biology services, and biologics, and to integrate AI and machine learning into its drug discovery and manufacturing processes.

CDMO, Samsung Biologics, has announced plans to construct a sixth manufacturing plant at its Bio Campus in Songdo, South Korea. Pending board approval, the expansion would increase the company's total production capacity to 964,000 liters by 2027. In addition, the company aims to establish a regional office in Tokyo, Japan by year-end to better serve its growing client base in one of the leading global markets.

At JPM 2025, James Park, CEO of Lotte Biologics, outlined the company’s dual CDMO strategy. The company will focus on small- to medium-scale drug production - including ADCs - at their Syracuse, New York facility, while large-scale drug production will be handled at the planned Songdo bio-campus in Korea.

Singaporean biotech, DotBio, is aiming to revolutionize cancer treatment by targeting exhausted T-cells with its tri-specific antibody, DB007. The antibody, built using DotBio’s modular DotBody technology, is designed to treat a broad range of solid tumors either as a standalone therapy or in combination with others.

Novo Holdings, the controlling shareholder of Novo Nordisk, intends to significantly expand Catalent, the contract drug manufacturer it completed its acquisition of in December 2024. Novo aims to potentially double Catalent's size over the next five years, aligning with anticipated U.S. policies under President Trump that emphasize domestic manufacturing.

U.S. CRDMO, BioDuro, has opened a new solid-phase peptide synthesis scale-up facility at its Shanghai campus to support peptide synthesis up to 800 mmol for a wide range of peptides, including linear and cyclic peptides, as well as peptide-drug conjugates.

Thermo Fisher Scientific projects a positive outlook for its CDMO services, influenced by industry dynamics and geopolitical factors. The now complete acquisition of Catalent by Novo Holdings is expected to reduce competition for Thermo in the CDMO sector.

Pharmaceutical packaging company, SCHOTT Pharma, has introduced its SCHOTT TOPPAC® infuse polymer syringe system; a new cap design for prefillable polymer syringes featuring tamper evidence at the individual syringe level.

Biologics and biosimilars CDMO, Tanvex, has successfully completed its acquisition of Bora Biologics, a subsidiary of Bora Pharmaceuticals. The companies will merge their biosimilar expertise and Tanvex’s FDA-licensed commercial-scale facility in San Diego with Bora Biologics' early-stage biologics CDMO capabilities in Taiwan to offer comprehensive, efficient end-to-end biologics solutions.

Governor Shapiro and Department of Community and Economic Development Secretary, Rick Siger, recently visited one of Adare Pharma Solutions’ facilities in Philadelphia to celebrate the company’s success and highlight the State’s commitment to economic growth.

Medical device company, Terumo, has announced the launch of its injection filter needle, marking the first step in its INFINO™ Development Program. The innovative needle design enhances safety and efficacy in hypodermic and intravitreal injections by incorporating a built-in filter to prevent the injection of particulates.

As the demand for advanced therapies continues to grow, CDMOs are fast becoming the solution for biopharma companies that need specialized expertise and capabilities that are scalable for their drug development and commercialization.

Regeneron Pharmaceuticals has acquired a UK-based biotech, Oxular, which specializes in retinal diseases to enhance its ophthalmology portfolio. The acquisition includes Oxular's proprietary ocular delivery technology and its Phase 2 therapy, OXU-001, which are currently under investigation for diabetic macular edema.

California-based, Lifecore Biomedical, has partnered with Nirsum Laboratories to provide CDMO services to support the clinical development of Nirsum's leading candidate for treating opioid use disorder (OUD) and alcohol use disorder (AUD), NRS-033. With the drug entering Phase 2 clinical trials, Lifecore will provide filled syringes for the studies.