Scorpius BioManufacturing implements lean clinical manufacturing techniques as a cost-effective, phase-appropriate approach that focuses on performing only the necessary work at each clinical development stage, streamlining the path to early-phase trials and helping partners conserve internal resources. By delaying process optimization until a drug candidate shows clinical success, a company can reduce financial risk and minimize cash burn, and only optimize and advance its investigational new drug’s development process as it shows adequate progression through trials. 

BioDuro-Sundia, the California headquartered contract research, development and manufacturing organization (CRDMO), has appointed Dr. Armin Spura as its new CEO. Dr. Spura brings over 20 years’ experience in life sciences, having led companies like Crown Bioscience and held senior roles including at Thermo Fisher and WuXi NEXTCODE. He aims to leverage BioDuro-Sundia’s integrated CRDMO platform, which spans from discovery to commercial manufacturing, to accelerate growth and deliver innovative solutions to clients globally.

In Regensburg, Germany, Aenova Group has significantly expanded its capabilities for the development and manufacturing of high-potent medicines. The investment aims to address the growing demand for highly potent active pharmaceutical ingredients (HPAPIs), which are used more frequently in treatments for cancers and autoimmune diseases. The upgraded facility will handle a broader range of manufacturing scales, ensuring high standards of quality and safety for high-potency drug production.

As 3,000 companies and 60,000 attendees finalize plans before heading to Milan for the 35th anniversary of CPHI, you might have started thinking about what’s on offer and who you are going to catch up with next week.

We spoke with executives from pharma and services companies to ask them what industry developments and trends interest them prior to this year’s event.

Oxford Biomedica has rebranded as OXB to reflect, it says, its transformation into a pure-play cell and gene therapy CDMO. The company says its brand reflects its commitment to technical excellence, innovation, and high-quality delivery at all stages of viral vector development, where it will offer expanded capabilities globally to support clients from early development through to commercial manufacturing.

Celltrion Inc., a South Korean biosimilar manufacturer, has announced its entry into the CDMO market. Founder and Chairman Seo Jung-jin shared the update during the Morgan Stanley Global Healthcare Conference, announcing the company’s plans to establish a wholly owned subsidiary focused on the CDMO market, adding that the company would explore options for new plant construction, either domestically or internationally.

Specialist CDMO BioCentriq has appointed Syed T. Husain as its new CEO. Husain will guide the company through its next growth phase as it focuses on advancing cell and gene therapy manufacturing from clinical to commercial stages. Husain’s previous expertise as Chief Commercial Officer at Resilience saw him lead commercial strategies across biologics and emerging therapies and will be crucial for BioCentriq’s expansion and support of innovative therapies.

Serán BioScience announced that it had completed an expansion to add eight state-of-the art process manufacturing suites at its facility in Bend, Oregon, adding around 130% more CGMP clinical manufacturing capacity. The suites will provide increased flexible capacity for late-stage clinical trial supply for small-molecule drugs.

Bayer has unveiled a new ecosystem aimed at supporting healthy aging, responding to growing consumer interest in wellness and longevity, by offering a range of products and services designed to promote better health outcomes as people age.

The first pills date back to roughly 1,500 BC, and whilst the pharmaceutical landscape continues to evolve, drug delivery via oral solid dosage (OSD) remains a dominant form due to the ease with which tablets are administered, patients’ familiarity with the dose form, and efficient manufacturing techniques.

Lonza has completed an expansion of its microbial manufacturing facility at Visp, Switzerland, to address the growing demand for microbial manufacturing - driven by the rise of smaller, more complex molecules in the biotech pipeline - and boost its capacity to meet the increasing demand for microbial-based biologics.

Bora Pharmaceuticals has formed a strategic alliance with Tanvex BioPharma to combine their respective strengths in biologics development and global manufacturing, leveraging Tanvex's U.S. FDA-licensed facility and biosimilar expertise with Bora's extensive CDMO capabilities, which include 10 global manufacturing sites.

Lotte Group, the South Korean conglomerate, plans to restructure its bio division by focusing on its profitable CDMO services business and shutting down loss-making Lotte Healthcare. The restructuring includes discontinuing its direct-to-consumer genetic testing business and transferring its health-functional food division to Lotte Wellfood.

After a challenging few years, the biotech sector is experiencing a bifurcation in funding. While early-stage companies struggle to secure financing, clinical-stage biotechs and those in ‘hot’ therapeutic areas are thriving. This “winner-takes-all” environment is driven by both VCs and big pharma companies, which are increasingly drawn to assets closer to market.

Eli Lilly is exploring a novel approach to antibody discovery by leveraging oblique antibody technology. The method aims to target previously inaccessible areas of high-value proteins, which could lead to the development of innovative therapies.

U.S.-based mammalian and microbial biologic CDMO, Scorpius Holdings, announced a 16% year-over-year revenue increase for the second quarter of 2024, reflecting the company's strong performance and strategic initiatives in the biopharmaceutical sector.

Bora’s Board of Directors has approved a deal whereby Bora Biologics will combine its biomanufacturing capabilities with those of Tanvex, a biopharma focused on biosimilars that also provides CDMO services. The deal, which is expected to close in the first quarter of 2025, will bring together Bora’s CDMO capabilities and expertise from Tanvex, as well as its FDA-approved commercial-scale facility in San Diego.

WuXi Biologics has secured 61 new projects in the first half of 2024, with half originating from the U.S. The proposed BIOSECURE Act, which targets named Chinese biotech firms including WuXi Bio because of national security concerns. Although Wuxi has reiterated its commitment to regulatory compliance and denies it poses any security threats, it saw modest revenue growth and a significant decline in profits.

Biopharmaceutical and biotech CDMO Fujifilm Diosynth Biotechnologies has inaugurated a state-of-the-art microbial manufacturing facility in Billingham, UK. The company says the new facility will enhance its large-scale microbial production capabilities.

Recently published reports (from The Brainy Insights & InsightAce Analytic Pvt. Ltd) suggest the CDMO industry is poised for significant growth that will continue into the next decade.