Korean biopharma, Celltrion, has announced plans to establish a wholly owned CDMO subsidiary by the end of 2024, leveraging its expertise in antibody development to compete with existing CDMOs by emphasizing its expertise in high productivity and cost efficiency. Facility expansion and commercial activities are set for 2025.

Evonik has announced layoffs of around 260 employees - in addition to previously announced job cuts - as the company continues its ongoing multi-year reorganization to streamline operations and reduce costs in its specialty chemicals business to improve profitability and focus on higher-margin growth areas.

Several U.S. consumer groups and labor unions have asked the FTC to block Novo Holdings planned $16.5 bn acquisition of Catalent, amidst concerns that the potential deal could stifle competition in the market for GLP-1 receptor agonist drugs.

The groups argue that the acquisition would further solidify Novo Nordisk's leading position - dominated by Ozempic and Wegovy – and that this could potentially lead to higher prices and reduced access to these critical medications. They also contend that the deal could give Novo Nordisk control over Catalent's production facilities, and thus limit its rivals' ability to manufacture competing drugs. The move comes amid growing scrutiny from lawmakers - including the U.S. Senator Elizabeth Warren - who has also raised concerns about the merger’s potential to reduce competition. Senator Warren has asked the FTC to closely investigate the deal.

Global CDMO, Recipharm, and integrated pharmaceutical specialists, Exela Pharma Sciences, have established a strategic alliance to enhance sterile manufacturing capabilities in the U.S. This partnership will leverage Exela’s FDA-approved facility with a focus on sterile injectables and complex biologics as both companies look to expand production capacity and offer comprehensive solutions for biopharmaceutical clients across U.S. and global markets.

Cell and gene therapy experts, Dark Horse Consulting, has acquired BioTechLogic, a leader in biopharmaceutical CMC and manufacturing consulting, to expand the company’s capabilities in cell and gene therapy, biologics, and vaccines. By combining expertise, Dark Horse aims to optimize development timelines and resources for CGT clients by enhancing technical operations and quality support.

The Pennsylvania Department of Community and Economic Development (DCED) recently announced that Adare had relocated its global headquarters from New Jersey to Philadelphia, and has been supported by a $2.9 mn investment from the U.S. Governor Josh Shapiro Administration. Adare has committed a further $16.8 mn investment to expand its two Philadelphia manufacturing and packaging facilities. In all, at least 115 new jobs will be created and a further 200 existing Pennsylvania jobs retained. The DCED said that the move demonstrates both Pennsylvania and Philadelphia as a premier hub for life sciences.

PCI Pharma Services is investing $365 mn to expand its facilities in the EU and US to enhance its capacity for advanced drug delivery and drug-device combination products. Key upgrades include a new center of excellence in Rockford, Illinois, and two new facilities in Dublin, Ireland, dedicated to injectable and oral solid dose drug packaging and assembly. This investment aims to support the entire lifecycle of complex therapies, from clinical development to commercialization.

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.