Responding to Demand with the Latest Service Offerings
Innovator companies are increasingly engaging with outsourcing partners in efforts to improve cost and time efficiencies across the complete drug development lifecycle.
The global bio/pharmaceutical industry is facing a crossroads: while therapeutic innovation continues at a rapid pace, the return on investment from such innovation is proving to be less pleasing for company shareholders. In fact, according to analysis from PricewaterhouseCoopers, only a select few companies have “influenced positive returns in the pharmaceuticals sector” since 2018, leading to a renewed focus on business strategy for many involved in bio/pharmaceuticals (1).
Adding to the lower than hoped for return on investment, increasing regulatory scrutiny, rising complexity of drug development, geopolitical uncertainties, and shifting patient expectations are leading innovators to engage with outsourcing service providers more readily to help improve cost and time efficiencies (2).
Driving Innovation in Drug Discovery
A key area where innovators can benefit from external assistance is during drug discovery, which can be time-intensive if there are limited capabilities to perform such tasks are not available in-house. Tackling this issue in particular, global CDMO, Samsung Biologics, recently launched advanced drug screening services to help innovators in drug discovery and development tasks. Using Samsung Organoids, companies can perform precision drug screening in order to identify effective compounds that have better patient responses (3).
Organoids are tissue-engineered, three-dimensional cell culture systems, crafted to replicate key functional, structural, and biological complexity of the corresponding in-vivo organ (4). As a result of their similarity to in vivo tissues, organoids have great research potential and can provide a platform for the toxicological evaluation of drugs, disease pathogenesis, and the mechanism of action of a drug (5).
“The latest service launch reflects our unwavering commitment to driving innovation by improving drug success rates and creating new possibilities in personalized medicine,” said John Rim, CEO and President of Samsung Biologics, in a company press release (3). “The addition of research services is a significant move for us to create added value for clients by supporting the drug life cycle from start to finish with thorough therapeutic analysis.”
Enhancing Bioavailability and Fast-Tracking Development
Poorly soluble compounds are an increasing concern for drug developers; however, as many of these compounds are useful as treatments for therapeutic areas that have high unmet clinical need, advanced formulation solutions to overcome the issue of poor solubility are becoming ever more critical. In light of this development hurdle, Almac Group has recently expanded its bioavailability enhancement capabilities to help provide innovators with a range of advanced formulation approaches (6).
The company’s investment into the Charnwood, U.K., facility comprised the addition of Buchi S300 and GEA PSD1 closed-loop spray drying technology and an extensive expansion of the analytical laboratories. Combined with the existing liquid capsule filling and non-sterile oral liquid formulation solutions, the new additions have broadened the company’s capabilities to enhance bioavailability.
“This investment is a direct response to the growing demand for sophisticated formulation solutions,” remarked James Hurst, VP Operations and Charnwood Site Head, Almac Pharma Services. “Spray drying is a cornerstone technology for enabling next-generation therapeutics, and our expanded capabilities ensure we remain at the forefront of pharmaceutical innovation.”
Earlier in the year, Aenova unveiled its new initiative, Aenovation program, that has been designed to accelerate the early development of pharmaceutical formulations. Through the deployment of a science-based rationale selection of formulation and technology, this program can help companies to fast-track their early development in a three-step process (7).
Starting with the API, the first step in the Aenovation program involves gaining an understanding of the solubility, permeability, solid-state properties, and powder physical characterization of the active, which helps to guide the formulation strategy. Then, with a fast and API-sparing screening program that employs solubility enhancing technologies, the formulation and prototype for the drug are selected. For the last step in the process, the manufacture of the early clinical phase material is scaled up to good manufacturing practice (GMP) lab and pilot-scale environments (7).
“Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimizing their resources,” explained Florent Bordet, Chief Scientific Officer at Aenova, in a company press release (7). “Our Aenovation program is a reflection of our commitment to innovation and excellence in pharmaceutical development.”
Expanding Presence in China
Since 2015, China has been reforming its regulatory processes to reposition the country as an innovative hub for the bio/pharmaceutical industry (8). As part of these efforts and to help improve the efficiency of manufacturing biologic drug products in the country, the National Medical Products Administration issued a pilot program to introduce segmented production processes for biologics (9).
Boehringer Ingelheim’s biopharmaceutical facility, located in Shanghai, China, qualified to participate in the pilot program, which will run through until the end of 2026. As a result, the company announced that it is expanding its BioXcellence service portfolio in China to be able to offer distinct service packages for different segments in biopharmaceutical production (10).
“We can build on our more than 40 years of experience with this segmented manufacturing business model, as it is well established in the U.S. and the EU. Now we’re eager to roll out this concept in China to better serve our customers’ needs, by enhancing a reliable and sustainable global supply of life-changing biopharmaceutical medicines to patients in need,” emphasized Andrea Rothmaler, Head of Boehringer Ingelheim’s contract manufacturing arm, BioXcellence, in a press release (10).
Biologics Manufacturing at Every Scale
Chinese headquartered contract research, development, and manufacturing organization (CRDMO), WuXi Biologics has also recently announced enhancements to its manufacturing capabilities by developing continuous drug substance (DS) production at pilot-scale with its WuXiUP platform (11). The service provider has accomplished this platform advancement by integrating various technologies, such as membrane chromatography and automated control systems, along with iterative enhancements to process analytical technology (PAT).
According to the company, the platform has achieved non-stop 24/7 operation of end-to-end, fully automated continuous production of DS at pilot scale. Next steps will involve deployment of the platform across the company’s major GMP facilities to offer clients accelerated timelines for their projects.
“The WuXiUP platform has already proved its technical maturity and viability in commercial manufacturing. And now it has reached another significant milestone: accomplishing fully automated continuous DS production at pilot scale,” commented Dr. Chris Chen, CEO of WuXi Biologics, in a press release (11). “Such achievements underscore WuXi Biologics’ steadfast dedication to furthering technological innovation, and advancing the standards for digitalization and automation in biopharmaceutical R&D and manufacturing — both of which are critical capabilities to improve quality and accelerate timelines.”
For many innovators in the field of advanced therapeutics, being able to efficiently handle smaller-scale manufacturing is becoming more important. Responding to this increased demand, Cytiva has expanded its portfolio of ÄKTA readyflux fully automated tangential flow filtration (TFF) systems (12).
The latest addition to Cytiva’s portfolio, the ÄKTA readyflux TFF system 500, has been designed to support drug developers encountering issues with lower volume manufacturing. Key challenges addressed by the new system include: scaling of processes from small-scale development to clinical and commercial manufacturing; efficiency of handling low-volume applications; simplifying technology transfers; reducing downtime and minimizing need for specialized skills with UNICORN software; and ensuring consistency across each batch (12).
“Customers need robust solutions with industry leading technology, but also operational flexibility to manage lower volumes,” said Ludovic Brellier, President, Hardware Solutions, Cytiva, in a press release (12). “The ÄKTA readyflux TFF system 500 is designed to provide these capabilities while maintaining the easy-to-use functions of the platform.”
Keeping Pace with Demand
Moving to commercial-scale manufacturing and FUJIFILM Biotechnologies has recently opened a site in Holly Springs, N.C., expanding its CDMO business and providing customers with a vast commercial-scale cell culture biomanufacturing site. In its first phase, the site comprises a capacity of eight 20,000 L mammalian cell culture bioreactors that encompass both drug product and DS manufacturing. The company will further add finished goods capabilities in 2026, while the second phase of the expansion will double the manufacturing capacity to bring the total number of bioreactors up to 16 (13).
“Our new commercial-scale manufacturing hub in the U.S. highlights Fujifilm’s dedication to supporting our partners in delivering biologic medicines targeting complex diseases,” explained Toshihisa Iida, Director, Corporate Vice President, General Manager of Life Sciences Strategy Headquarters and Bio CDMO Division, FUJIFILM Corporation, Japan, and Chairman, FUJIFILM Biotechnologies, in a press release (13). “Securing strategic manufacturing capacity is crucial to our ‘Partners for Life‘ strategy, to help ensure a stable supply chain for our customers.”
To facilitate this expansion, the company has employed its kojoX production model, which is an innovative approach that allows the company to build near-identical facilities in multiple locations. By employing this approach, FUJIFILM Biotechnologies can offer its customers agility, scalability, and efficiency across the U.S., Europe, and Japan.
“I am inspired by our team’s incredible achievement in delivering this ambitious manufacturing hub in under five years. Leveraging our pioneering kojoX modular facility design approach, our teams and partners are able to accelerate build times, which will help get medicines to patients faster,” noted Lars Petersen, President and CEO, FUJIFILM Biotechnologies, in a press release (13). “This site bridges a critical gap in supply; with the world’s aging population driving a surge in chronic diseases, it’s vital to keep pace with the demand for life-changing medicines.”
References
PwC. Next in Pharma 2025: The Future is Now. Insight, Jan. 8, 2025.
Precedence Research. Biotechnology and Pharmaceutical Services Outsourcing Market Size, Share, and Trends 2025 to 2034. Market Research Report, Jan. 10, 2025.
Samsung Biologics. Samsung Biologics Launches Drug Screening Services, Samsung Organoids. Press Release, June 16, 2025.
Zhao, Z.; Chen, X.; Dowbaj, A.M.; et al. Organoids. Nat. Rev. Methods Primers. 2022, 2, 94.
Liu, X.; Zhou, Z.; Zhang, Y.; et al. Recent Progress on the Organoids: Techniques, Advantages, and Applications. Biomed. Pharmacother. 2025, 185, 117942.
Almac Group. Almac Group Expands Bioavailability Enhancement Capabilities — Addressing a Critical Need in Drug Development. Press Release, Sept. 9, 2025.
Aenova. Aenova Launches Aenovation Program to Accelerate Pharmaceutical Development. Press Release, May 7, 2025.
Liu, S.; Hu, H.; Ge, C.; et al. The Rise of China’s Pharmaceutical Industry from 2015–2024: A Decade of Innovation. Nat. Rev. Drug Discov. From the Analyst’s Couch, July 21, 2025.
CMS Law-Now. China Launched Pilot Program on Segmented Production of Biological Products. Article, Dec. 27, 2024.
Boehringer Ingelheim. Boehringer Ingelheim Enhances Biopharmaceutical Contract Manufacturing Services in China. Press Release, March 4, 2025.
WuXi. WuXi Biologics’ WuXiUP Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale. Press Release, Aug. 12, 2025.
Cytiva. Cytiva Launches New ÄKTA Readyflux System for Smaller Scale Manufacturing. Press Release, July 29, 2025.
FUJIFILM Biotechnologies. FUJIFILM Biotechnologies Celebrates the Grand Opening of its Commercial-Scale Cell Culture Manufacturing Site in North Carolina. Press Release, Sept. 24, 2025.
Illustration by Public domain vectors on Unsplash