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. 

Pace Life Sciences has acquired Catalent’s small molecule analytical laboratories in Research Triangle Park, North Carolina. Pace said that the acquisition strengthens its ability to provide comprehensive analytical services for early-stage drug development through to commercialization, expands its U.S. network, and enhances its ability to support clients with faster and more reliable solutions.

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.

Just prior to the show, Adare Pharma Solutions announced a partnership with Laxxon Medical to introduce cGMP 3D printing capabilities at Adare’s Pessano facility in Milan. Using technology licensed from Exentis Group, the collaboration will produce advanced 3D-printed oral dosage forms that offer customizable drug release profiles and enhanced bioavailability. Adare will add the capability to its Vandalia, Ohio, site by the end of 2024.

Ahead of CPHI Milan, a recently published survey shows positive growth predictions for CDMOs in 2025, despite concerns about the BIOSECURE Act. While 49% of respondents said they are highly optimistic about CDMO expansion, there are mixed views on the Act itself, with 38% of respondents suggesting it was politically motivated, 19% saying they perceive Chinese CDMOs as a threat, and 43% supporting the diversification of supply chains.

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.

A CPHI Milan survey suggests that biologics and Tides (peptides and oligonucleotides) are set to become the fastest-growing areas for CDMOs over the next five years. Biologics were favored by 53% of respondents, with Tides at 43%, whereas demand for small molecule services will remain steady.

Adare, the global technology-driven oral dose CDMO, will mark CPHI with the announcement that it has partnered with Laxxon Medical to provide GMP 3D oral dose printing from Adare’s Pessano facility in Milan.

Serán BioScience, the development-stage CDMO based in Bend, Oregon, has secured a $200 mn investment from Bain Capital to support the building of its first large-scale commercial manufacturing facility. The new site will enhance Serán’s capabilities in drug development and production to support a growing pipeline of pharmaceutical innovations.

The Biosecure Act, recently passed by the U.S. House of Representatives, may force U.S. biotech and pharma companies to sever ties with major Chinese CROs and CDMOs, such as WuXi AppTec and Complete Genomics.

The U.S. company’s initial public offering (IPO) on the Nasdaq index raised $362 mn, which the company says it will use to support pivotal Phase 2/3 trials for its lead asset - ficerafusp alfa - targeting head and neck squamous cell carcinoma. The listing follows a broader uptick in biotech IPO activity, with Zenas BioPharma and MBX Biosciences also going public, marking one of the busiest biotech IPO weeks in 2024. 

Pfizer’s experimental drug, ponsegromab, has shown promising results in a Phase 2 clinical trial aimed at treating cancer cachexia - a serious condition characterized by muscle and weight loss. Presented at the 2024 ESMO conference, the candidate achieved weight gains of up to 5.6% in patients suffering from cachexia due to lung, pancreatic, or colorectal cancer, surpassing the 5% threshold deemed clinically significant. Pfizer is planning to commence Phase 3 trials by 2025, and aims to provide the first FDA-approved treatment for this life-threatening condition, which currently relies on nutritional support and anti-inflammatory treatments.

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.

Bora Biologics has recently made a series of strategic moves aimed at better positioning itself to rapidly respond to industry’s evolving demands for capacity, integration, and policy developments - such as the U.S. BIOSECURE Act. As a result, the company is well positioned to capitalize on the growing demand for large-molecule CDMO services and opportunities presented by the growing demand for onshoring and friendshoring.

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.

Global electronics company Molex, through its subsidiary Phillips Medisize, has entered into an agreement to acquire Vectura Group Limited from Philip Morris International. Vectura, based in the UK, specializes in inhalation drug delivery, including device and formulation development for dry powder inhalers, metered dose inhalers, and nebulizer products.

Agilent Technologies has completed its acquisition of BIOVECTRA, a Canadian CDMO specializing in biologics, highly potent pharmaceuticals, and targeted therapeutics. Now part of Agilent's Diagnostics and Genomics Group, the acquisition will enhance Agilent's portfolio with advanced manufacturing capabilities for gene editing and biologics production.

A significant FDA inspection backlog is delaying new drug approvals, particularly for drugs manufactured overseas. Exacerbated by the pandemic, the delay in regulatory approval impacts the availability of new treatments in the U.S. and could hinder the introduction of innovative therapies. Although the FDA is working on reducing the backlog, the delays are causing concerns across the pharmaceutical industry.