Abzena Ltd.

Several brand-name drugmakers believe they will withstand any drug pricing impacts from President Donald Trump’s tariffs — and manufacturers that contract with pharma companies will likely be unaffected, analysts say. Trump’s tariff plans were met with immediate concern from some pharmaceutical industry groups that drug prices in the US would rise and shortages would deepen. But companies like GSK and Novo Nordisk insisted last week they’re well-positioned to absorb any increases in cost, should the tariffs be imposed. And contract development and manufacturing organizations (CDMOs) like Abzena and Lonza are likely too downstream in the supply chain from tariffs, William Blair analyst Max Smock said in an interview with Endpoints News . Any costs would be passed to their pharma company customers to handle. Tariffs on imports from Mexico and Canada were delayed by one month after Trump reached deals with both countries’ leaders. Trump on Monday announced additional tariffs on aluminum and steel imports into the US. Meanwhile, tariffs are underway in China, which is a big supplier of APIs. Trump has delayed potential tariffs on small packages under $800 from China. The tariffs will hit generic drugmakers the hardest and could force them out of the market due to low profit margins, Association for Accessible Medicines CEO John Murphy warned . The Trump administration needs to work on incentives for generic manufacturers, Murphy told Endpoints News in an interview. But brand-name heavy hitters like GSK will have “no exposure or minimal exposure” to Trump’s tariffs and can absorb any changes, GSK CEO Emma Walmsley told reporters in a call last week. Merck CFO Caroline Litchfield said during an investor call that she expects “immaterial impact.” Novo Nordisk CEO Lars Fruergaard Jørgensen said Novo is “well-positioned” to handle any impact, but said the company is not “immune,” Reuters reported . Meanwhile, Twist Bioscience said it could use the tariffs to its advantage. The taxes will likely be a headwind for foreign competitors, CEO Emily Leproust said during the company’s earnings call. Compared to generic drug companies, brand-name drugmakers have much higher profit margins, around 70% to 90%, so many will be able to absorb the cost of tariffs, Abzena CEO Matthew Stober told Endpoints. CDMOs are contracted by pharmaceutical companies to manufacture all, or parts of, their drug products in factories. Any increases in cost for manufacturers are likely to be passed onto their pharmaceutical customers, RBC Capital senior healthcare analyst Charles Weston said. He likened this to the rising cost of goods during the pandemic. CDMOs “pretty much all were successful in passing on the cost to customers,” he said. Smock said the tariffs feel like an extension of the Biosecure Act , which benefited some CDMOs. Biosecure is a draft bill that would ban US pharmaceutical companies from working with certain Chinese suppliers, causing pharma companies to look for alternatives . Despite Biosecure being left out of the end-of-year must-pass defense legislation, Stober said his CDMO was still feeling the tailwinds from the bill. Yet some foreign CDMOs are still looking to minimize any potential risks from the tariffs. Korean CDMO Celltrion said it’s planning to buy US-based factories as a means to sidestep the tariffs. The only issue with this is there are limited available sites in the US for CDMOs to absorb, Smock said. Despite concerns that tariffs could cause drug prices to soar, Stober said they could push for more US local manufacturing, which could in turn cushion drug shortages. The US supply chain is vulnerable to geopolitical tensions, especially for raw materials for drugs like antibiotics, which are sourced from China, he added. There’s been a recent push for the US to boost its local manufacturing footprint. But moving operations to the US comes with high costs, and it can take months to years to tech transfer over operations, Weston said. Further, building new capacity can take around three to five years to get online, Murphy said. Some pharma clients have previously requested that their contracted partner, like Lonza, move operations to one of their US sites, Smock said. But this is also costly and time-consuming. Despite the looming pressure of tariffs and the uncertainty of how they will play out, branded drugmakers and their manufacturing partners seem to be likely to escape any major headwinds. Meanwhile, generic producers may struggle to keep their business profitable. Editor’s note: This story was updated with Trump’s announcement on steel and aluminum tariffs.

CAMBRIDGE, England and SAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, announced the expansion of their early and late-phase analytical capabilities to now include GMP cell-based potency assays at their Cambridge, UK and San Diego, CA development and manufacturing facilities. The expansion enhances Abzena's extensive bioassay offering, providing customers with a more comprehensive, streamlined, and cost-effective way to access critical data faster. GMP cell-based potency assays play an essential role in quantitatively measuring the biological activity of a biopharmaceutical, and the cytotoxicity of the payload of an Antibody-drug conjugate (ADC), for both GMP product release and stability testing. By adding this capability to their global toolkit, Abzena will be able to provide precise and reliable data on drug potency, alongside developability and characterization data including mechanism of action (MOA) and immunogenicity, which are essential for regulatory submissions. Dr Campbell Bunce, CSO and Cambridge Site Head at Abzena said, "We recognize that high-quality data is the cornerstone of effective decision-making. When it comes to early-phase biopharmaceutical programs, especially ADCs, developers must have a reliable CRO partner with the deep knowledge and technical capabilities required, and who can deliver the necessary data needed to successfully reach their next target inflection point." "Our established expertise and reputation have allowed us to extend our early-phase capabilities to include GMP cell-based potency services at our global sites, addressing a critical need for our customers. This significant milestone further demonstrates our commitment to providing comprehensive, end-to-end support for our customer's next-generation programs that drive successful outcomes from discovery to the clinic and onwards towards commercial." Sean O'Brien, SVP & San Diego Site Head at Abzena shared, "Biological drug development requires robust analytical support across all phases of development. At Abzena, we've placed significant importance on building a state-of-the-art analytical toolkit because we understand the value that it provides to our customers." "Our goal is to help our customers optimize their drug development strategies, secure funding, and navigate regulatory pathways more effectively. We will continue to invest in our expertise and expand our laboratories so that our broader analytical offering can best support them in their mission to get life-changing medicines to patients." All the Cambridge, UK site's services are fully integrated with Abzena's development and manufacturing services at their US facilities in San Diego, CA, and Bristol, PA. About Abzena Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world's leading private equity investors. Learn more at abzena.com. SOURCE Abzena WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

By offering comprehensive, integrated solutions, Abzena aims to streamline drug development processes and minimize risks for customers, helping to accelerate timelines and enhance production. OSP had a catch-up with them after the event to find out how things went. What new products or innovations did your company showcase at CPHI Milan 2024 this year? ​ At CPHI Milan 2024, Abzena highlighted its enhanced cell line development platform, AbZelectPRO, and its latest advancements in integrated drug development and manufacturing capabilities for antibody-drug conjugates (ADCs). The AbZelectPRO platform enables customers to go from DNA to research cell bank (RCB) in 10 weeks, producing up to 8g/L from stable clones. This high-producing and highly stable platform offers an optimized expression cassette that’s proven to enhance protein expression by leveraging novel genetic elements, leading to improved production levels across a wide range of protein targets, including difficult-to-produce proteins such as bi-specifics and fusion proteins. Abzena also showcased its high-potency handling capabilities for the development and cGMP manufacture of ADCs, along with its next-generation site-specific linker technology, ThioBridge™. Having linker-payload design, bioconjugation, complex chemistry, and GMP manufacturing capabilities all under a single organization, enables us to de-risk and streamline the development of its customer’s ADC programs-  from discovery through commercial launch. googletag.cmd.push(function () { googletag.display('text-ad1'); }); What did you achieve at CPHI this year? ​ Abzena’s goal at CPHI Milan was to engage with industry leaders and innovators to foster collaborations that drive biopharmaceutical drug development forward. We demonstrated how the company's fully integrated approach can add value to our customers’ projects by simplifying complex development processes and minimizing risks. Additionally, we gained insights into emerging industry trends and customer needs to guide continuous efforts to improve and refine our services. How does your company stay ahead of industry trends and developments in the pharmaceutical sector? ​ The company stays ahead of industry trends by actively engaging with the pharmaceutical community and continuously adapting to the evolving landscape. We participate in key industry conferences, connecting with thought leaders and innovators to gain insights into emerging technologies and market dynamics. Our teams closely monitor regulatory developments and global events that impact supply chains, capacity, costs, and investments in the sector. We invest in talent development and foster a culture of innovation across our global organization. By encouraging collaboration between our research, development, and manufacturing teams, we ensure that new ideas and technologies are rapidly integrated into our processes. This proactive approach allows us to anticipate industry shifts and adjust our strategies accordingly, ensuring we provide our customers with the most up-to-date and effective solutions. Our commitment to staying informed and adaptable enables us to help our customers navigate uncertainties and succeed in a competitive market. What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer to your customers? ​ Abzena distinguishes itself through our fully integrated capabilities that span from early research and development, through to clinical and commercial manufacturing for complex biologics and Antibody-Drug Conjugates (ADCs). We prioritize building strong partnerships, focusing on transparency and collaboration to achieve successful outcomes. Our ability to manage complex projects efficiently provides significant value by reducing risk and accelerating time to market. Our suite of bioassays, including our EpiScreen 2.0 immunogenicity platform, allows us to assess the potency, efficacy and safety of our customers' products.  This gives them the insight to make data-driven decisions early on in their development journey, so they can start smart and progress fast. By offering linker-payload design, development, and ADC manufacturing within a single organization, we reduce supply chain complexity, streamline development processes, and minimize risks for our customers. Our tightly integrated research and manufacturing teams work seamlessly, incorporating cutting-edge technologies—including our proprietary ThioBridge platform—to accelerate timelines, reduce costs, and enhance reliability from early-stage research to full-scale production. Our commitment to innovation and technological leadership keeps us at the forefront of ADC development. We continuously invest in new technologies and expand our manufacturing capabilities, including commercial-scale production, to meet the evolving needs of the pharmaceutical industry. Operating across multiple global sites, we provide scalable solutions and international expertise, supporting projects at all stages. By simplifying the path from research to market, we deliver significant value to our customers, helping them achieve clinical success efficiently and effectively. Can you discuss any plans for expansion or market growth in the pipeline? ​ The company is continually exploring opportunities to expand our global footprint and enhance our service offerings. We are investing in  our manufacturing capacity to support commercial scale programs and incorporating new technologies to meet the growing demands of the pharmaceutical industry. These plans aim to strengthen our position as a leading CDMO+CRO and ensure we can support our customer’s needs as they scale. What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them? ​ The pharmaceutical market is experiencing a tightening of investment, particularly in early-stage biotech funding. While funding hasn't disappeared, companies are more cautious about allocating resources. Abzena is addressing this challenge by working more closely with our customers to demonstrate the value and efficiency of our services. We build trust through collaborative relationships, offering flexible and scalable solutions that help our customers maximize their investment. By understanding their specific needs and constraints, we're able to tailor our approaches to deliver meaningful results, even in a more competitive funding environment.