Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

Datwyler NeoFlex Plungers for large volume biologics | © Datwyler

Datwyler’s newly launched coated plungers in the NeoFlex line come in sizes fit for containers aimed at large-volume auto-injectors and wearable devices. The new prefilled syringe 10 mL with its NeoFlex Cartridge Wearable 10 mL is designed for high quality and safety standards with the new plungers, which ensure the stability and safety of large-molecule drugs. These plungers are completely covered in a non-fluorosurfactant grade fluoropolymer coating, which prevents rubber particles from shedding and minimizes degradation from extractables and leachables. The plungers are inherently lubricious, which eliminates the need for silicone to ensure smooth operation inside the syringe or cartridge barrels. This characteristic also supports compatibility with complex formulations, which is especially crucial for the effective delivery of a highly sensitive, highly viscous biologic.

Articles

Datwyler has launched new coated plungers in its NeoFlex line that are suitable for large volume biologics.

Coated Plungers for Large Volume Biologics

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept | Image Credit: © Dilok – stock.adobe.com

Swiss biotechnology company, Roche, has entered into a definitive agreement to acquire clinical-stage biopharmaceutical company, Poseida Therapeutics. The merger agreement was announced by Roche in a Nov. 26, 2024 company press release (1).

Under the terms of the merger, Roche will gain access to Poseida’s good manufacturing practice (GMP) manufacturing capabilities and its R&D assets, in addition to the programs and pipeline products that the companies are currently collaborating on. Assets that will be incorporated fully into the Roche Group on completion of the acquisition include allogeneic chimeric antigen receptor (CAR) T-cell therapeutic programs aimed at B-cell malignancies, hematologic malignancies, and solid tumors, among other things.

“This exciting acquisition will allow us to drive further progress in allogeneic cell therapy while leveraging the successful existing partnership with Poseida,” said Levi Garraway, head of Product Development and chief medical officer at Roche, in the press release (1). “We are very encouraged by the early clinical data, and this acquisition builds on our joint progress to catalyze the development of potentially first and best-in-class cell therapies in oncology, immunology, and neurology.”

The merger agreement between the two companies builds upon their existing strategic relationship that was initially formed in 2022 and was aimed at the development of off-the-shelf CAR-T cell therapies to address the unmet medical needs of patients with hematologic malignancies (2). Moving forward, Poseida therapeutics, Roche, and Genetech—a member of the Roche Group—will focus on delivering the next generation of off-the-shelf CAR-T cell therapies with higher potency and favorable safety at scale to be able to reach a broader patient population.

“Our interest in cell therapy is directly tied to our commitment to discovering and developing pioneering medicines with substantial patient benefit,” added Aviv Regev, head of Genentech Research & Early Development. “We are excited to bring together cutting-edge scientific approaches and expertise to tap into the full transformative potential of cell therapy.”

A tender offer will be provided by Roche to acquire all outstanding shares of Poseida Therapeutics’ common stock at a value of US $9 per share, which represents a total equity value of approximately US $1 billion. Both boards of Roche and Poseida Therapeutics have already unanimously approved the merger agreement. The transaction is expected to close during the first quarter of 2025 and is subject to the relevant closing conditions.

1. Roche. Roche Enters into a Definitive Agreement to Acquire Poseida Therapeutics, Including Cell Therapy Candidates and Related Platform Technologies. Press Release, Nov. 26, 2024.
2. Poseida Therapeutics. Poseida Therapeutics Announces Strategic Global Collaboration with Roche Focused on Allogeneic CAR-T Cell Therapies for Hematologic Malignancies. Press Release, Aug. 3, 2022.

The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, including cell therapy candidates.

Roche Enters Definitive Merger Agreement to Acquire Poseida Therapeutics

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - stock.adobe.com

German contract development and manufacturing organization (CDMO), Adragos Pharma, has announced its acquisition of Swiss aseptic fill/finish manufacturing company, Baccinex, in a Nov. 25, 2024 press release (1). Through the acquisition, Adragos Pharma will enhance its sterile manufacturing capabilities and expand its global network.

Baccinex has more than 20 years of experience in aseptic fill/finish services for liquid and lyophilized vials and is based in Courroux, Jura, in Switzerland. The company’s Jura facility is both European Union (EU)-good manufacturing practice (GMP) and US FDA-certified and specializes in clinical trial supplies and small-to-medium scale commercial production.

Under the acquisition agreement, Dr. Ursula Bausch, who founded Baccinex, will continue her position as CEO and she will also remain a shareholder in the company. “Joining Adragos Pharma marks a new chapter for Baccinex. Our shared commitment to quality, innovation, and customer-centric solutions creates an exciting synergy that will enable us to deliver even greater value to our clients worldwide,” Bausch said in the press release (1).

Additionally, the acquisition of Baccinex aligns with Adragos Pharma’s global expansion strategy. “The acquisition of Baccinex represents a significant milestone for Adragos. Baccinex’s proven expertise in sterile liquids and lyophilization, combined with its operational excellence, enhances our ability to provide integrated solutions from development through to commercial supply. This addition strengthens our position as a global partner of choice for high-quality pharmaceutical manufacturing,” added Dr. Andreas Raabe, founder and CEO of Adragos Pharma, in the press release (1).

Adragos Pharma has been making strides to further its global footprint with various acquisitions and, in addition to the most recent Swiss addition, has manufacturing sites located in Germany, France, Greece, Norway, and Japan.

On Nov. 7, 2024, the company announced the launch of a cutting-edge ampoule filling line at its Livron facility in France, enhancing its production capacity to over 160 million ampoules per year (2). “We recognized not only a regulatory demand in Annex 1 but also an urgent need for greater capacity, particularly for larger-volume ampoules. That’s why we installed this fourth line, allowing us to offer a capacity of over 160 million ampoules, including options up to 20 mL, tailored to serve our clients’ evolving requirements,” explained Marco Gorgas, CCO of Adragos Pharma in a press release (2).

In April 2024, Adragos Pharma also highlighted its actions to reinvest in the solid dosage market through their plans to enhance the manufacturing capacity of its Kawagoe plant in Japan to meet the anticipated demand of 2 billion tablets in the future (3). “Our business has progressed seamlessly, surpassing our initial goals. Moving into the second year and beyond, we will further enhance the manufacturing capacity of the Kawagoe plant, primarily focusing on solid formulations, to meet (growing) demands,” stated Keizo Yanagisawa, president and representative director of Adragos Pharma, in a press release (3).

1. Adragos Pharma. Adragos Pharma Acquires Baccinex—A Leading Swiss Sterile Fill-Finish Expert. Press Release, Nov. 25, 2024.Swiss Sterile Fill-Finish Expert. Press Release, Nov. 25, 2024.
2. Adragos Pharma. Project Future: We Launched Our New Production Line in Our Livron Facility! Press Release, Nov. 7, 2024.
3. Adragos Pharma. Our Strategic Expansion in Japan: Reinforcing Production to 2 Billion Tablets and Aiming to be the “Most Trusted CDMO”. Press Release, April 8, 2024.

Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.

Adragos Pharma Strengthens Sterile Manufacturing Capabilities with Baccinex Acquisition

The KinetiSol® Technology: Disrupting the Solid Amorphous Dispersion Landscape

to provide an overview of AustinPx, the company's bioavailability offerings, and KinetiSol technology, which represents a major breakthrough in amorphous dispersions. Learn more about:

How AustinPx was created and the strategy behind taking a technology company and turning it into a CDMO;

The origin of KinetiSol and how it can provide a faster, broader, and greener technology for amorphous solid dispersions;

How KinetiSol can alleviate challenges associated with spray drying.

Videos

Elizabeth Hickman (Chief Business Officer, AustinPx) explains the company's approach to improving bioavailability, highlighting KinetiSol technology.

KinetiSol® Technology: Disrupting the Solid Amorphous Dispersion Landscape

Heidi Casaletto, Vice President of Global Marketing, Catalent, comments on the significance of developing biologics with a 'patient first' philosphy.

Leveraging Integrated Patient-Centric Innovations When Developing Today's Biologics

Catalent is dedicated to improving lives by helping people live better and healthier. With a diverse team of individuals who often have personal connections to the diseases they work to address, the company approaches its mission with empathy and purpose. Catalent goes beyond viewing its work as merely creating products, recognizing that each batch represents hope and health for real patients and their families. This commitment is ingrained in everything they do, embodying a "patient-first" value that drives their efforts.

Equally, Catalent is deeply invested in its customers, understanding their challenges and acting as a strategic partner to deliver tailored solutions. By fostering close collaboration and working with urgency, the company aligns with the transformative potential of its customers’ therapies. This approach helps streamline processes, reduce complexity, and ensure outcomes that prioritize efficiency and quality.

Catalent’s brand reflects strength, reliability, and a steadfast focus on service. It embodies a commitment to exceeding expectations and delivering exceptional value to both customers and patients. This dedication to making a meaningful impact defines Catalent’s identity and drives its mission forward.

Want to learn more? Watch episode 2 of this series 

Heidi Casaletto, Vice President of Global Marketing, Catalent, comments on the significance of developing biologics with a 'patient first' philosphy.


Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics 

Nicholas Saraceno is editor at Pharmaceutical Commerce.

Kedrion Biopharma, a US-based biopharmaceutical company specializing in plasma-derived therapeutics, announced on Nov. 19, 2024 that FDA has approved its manufacturing facility in Bolognana, Italy, to produce Ryplazim (plasminogen, human-tvmh), a plasma-derived human plasminogen indicated for treating patients with plasminogen deficiency type 1 (PLGD-1), or hypoplasminogenemia (1).

PLGD-1 is a rare chronic disease that mainly appears in the form of “abnormal extra-vascular fibrin-rich, ligneous” lesions on various mucosal surfaces throughout the body. Most notably, lesions occur in the eye (known as ligneous conjunctivitis); however, their appearance in the respiratory, gastrointestinal, and genitourinary tracts—along with the central nervous system, ears, mouth, and skin—is not uncommon. They can potentially lead to serious consequences, including obstruction of airways; infertility; and hydrocephalus, along with vision and hearing loss.

"The FDA's approval of our Bolognana facility is a pivotal moment for our company, and I want to thank all employees worldwide who contributed to this achievement," said Bob Rossilli, chief commercial officer, global business and US general manager, Kedrion Biopharma, in a company press release. "This expanded capacity for Ryplazim means we can provide treatment for more patients with PLGD-1. Offering a product like [Ryplazim] to patients in need is truly a privilege."

This development signifies greater patient access to this PLGD-1 medication, not only in the United States, but globally as well. Ryplazim is considered the first and only FDA-approved therapy specifically for the PLGD-1 indication after receiving approval in June 2021; Kedrion officially announced plans to commercialize and distribute the product later that year (2). The active ingredient in Ryplazim is plasminogen, which is purified from human plasma (3). Treatment with Ryplazim helps to increase the plasma level of plasminogen, helping to limit or remove the lesions.

In a single-arm, open-label (unblinded) clinical trial that enrolled 15 adult and pediatric patients with PLGD-1, patients were administered Ryplazim every two to four days for 48 weeks. Overall, the medication’s effectiveness was apparent by at least a 50% improvement of their lesions in all 11 patients who had lesions at baseline, while there were no new lesions in any of the 15 patients through these 48 weeks (3). The most common side effects that patients reported were abdominal pain, back pain, bloating, bleeding, constipation, dry mouth, dizziness, fatigue, limb pain, nausea, headache, and joint pain (3).

"With increased awareness of PLGD-1, the expanded capacity of Ryplazim ensures we are better equipped to meet the growing demand, noted Rebecca Bialas, MD, co-founder and chair of The Plasminogen Deficiency Foundation, in the release (1). “This means more patients who receive the correct diagnosis can be confident they will get the treatment they so desperately deserve and need. This is an exciting time for the PLGD-1 community, marking a significant event in our collective journey towards better health."

1. Kedrion Biopharma. FDA Approves Kedrion's Bolognana Facility for Production of First and Only Treatment for PLGD-1, Ryplazim. Press Release. Nov. 19, 2024.
2. Kedrion Biopharma. Kedrion Biopharma to Commercialize Ryplazim in US. Press Release. Oct. 20, 2021.
3. FDA. FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder. Press Release. June 4, 2021.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

On Nov. 20, 2024, Fujifilm Diosynth Biotechnologies announced the completion of an expansion at its Thousand Oaks, Calif., cell therapy manufacturing facility (1). At a celebration for the opening of the updated facility, the company also recognized the issuance of a Certificate of GMP Compliance of a Manufacturer for the site, granted to it by the European Medicines Agency (EMA).

The investment project was originally announced (2) in December 2023 as one component of the company's $200 million cell therapy development and manufacturing investment project; the plan also involves financially supporting its Fujifilm Diosynth Biotechnologies’ California site, Fujifilm Cellular Dynamics, Inc.’s new headquarters (HQ) in Madison, Wis., and the Cellular Dynamics' new HQ with cell therapy manufacturing services, which is expected to be up and running by 2026.

When it comes to the Thousand Oaks location, the development project features the advancement of the development labs and welcomes two new independent cell therapy production suites to the mix, which boosts cleanroom capacity. The current good manufacturing practice (CGMP) suites are capable of automated cell separation and selection, with expansion equipment, in-built decontamination for rapid changeovers, and heating, ventilation, and air conditioning systems that can support either Grade B or C backgrounds.

Further, these suites can handle either open or closed processing—they’re also large enough to accommodate multiple patients’ autologous program lots, or even greater volume batches for allogeneic programs for both the clinical and commercial marketplaces.

“The completion of the expansion at our California cell therapy facility demonstrates our ability to support the growing needs of our early-to-late-stage allogeneic customers and late-phase autologous customers for commercial cell therapies," said Lars Petersen, president and CEO, Fujifilm Diosynth Biotechnologies, in a company press release (1). “As our industry realizes the promise of precision medicine, we are pleased to be at the ready to support production at our California facility, with the specialized skill and expertise of our team on-site.”

As alluded to previously, the California plant recently was given EMA regulatory approval, specifically for the manufacturing of sterile, biological medicinal products, and quality control testing specifically for Atara Biotherapeutics’ Ebvallo (tabelecleucel or tab-cel), which is a monotherapy that was approved in Europe for adults and children with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (r/r EBV+ PTLD).

Overall, in 2023, the global cell therapy market size was estimated to be valued at $4.8 billion, and forecasts are anticipating that the market will continue to grow at a compound annual growth rate of 37% during 2023 to 2030 forecast period (3).

“I am very proud of our entire team for reaching these important milestones, which will benefit patients that rely on these important cell therapies,” commented Dave Bolish, site head of Fujifilm Diosynth Biotechnologies, California, in the release (1). “The recent EMA GMP certification exemplifies that our high-quality manufacturing processes, systems, talent, and world-class facility meet regulatory requirements, and we have the agency’s trust to manufacture and deliver product on behalf of our partner.”

1. Fujifilm Diosynth Biotechnologies Celebrates the Expansion Completion at its California Cell Therapy Facility. Press Release. Nov. 20, 2024.
2. Fujifilm to Invest USD 200 Million to Expand Cell Therapy Development and Manufacturing Capabilities. Press Release. Dec. 4, 2023.
3. Fujifilm estimates based on Evaluate Pharma November 2023.

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

Fujifilm's Cell Therapy Facility Expansion Completed

On Nov. 19, 2024, Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), announced that it is investing $3.6 million into its prefilled syringe (PFS) services, specifically to boost its advanced labeling, automated visual inspection, and fill/finish technology (1). The investment will allow the CDMO to provide end-to-end, streamlined solutions for drug manufacturing.

Pii’s decision was partially influenced by the demand for prefilled syringe solutions in the pharmaceutical and biotech sectors. The aforementioned investment will go towards a syringe labeler, along with an Antares automated visual inspection (AVI) system.

“With this expansion, Pii strengthens its role as a comprehensive partner, allowing clients to achieve faster time-to-market by managing every step of the PFS process,” said John Fowler, Pii’s CEO, in a press release. “Our streamlined approach will support customers in optimizing both cost and quality, meeting stringent regulatory demands, and ultimately improving patient access to essential therapies.”

The branded syringe labeler is in the process of being installed, and is expected to be fully operational by either the first half or early second half of 2025. Essentially, it automates syringe labeling, plunger insertion, and safety device integration.

The concept of combining advanced labeling, automated visual inspection, and fill/finish tech services limits logistical and regulatory complexities when it comes to product delivery timelines. It also helps with quality control, which reduces the risk of errors.

As for the Antares AVI technology, the anticipated operational date is the third quarter of 2025. The system is able to detect air bubbles, cracks, particles, and fill-level discrepancies. It also reportedly decreases dependence on manual inspections, while boosting large-scale production turnaround times, and supporting regulatory requirements that surround quality analysis and traceability.

In other Pii news, over the past year, the company had announced a new leadership team (2) consisting of Joseph Kiely as chief financial officer; George Sanders as vice-president (VP) of human resources, Thomas Pamukcoglu as VP of quality; James Drob as head of aseptic manufacturing; John Phillips as VP of sales; Bob Talley as general counsel and assistant secretary, and Alexander Borodin as senior director of supply chain. Devan Patel was also promoted to VP of client services, while Sara Frederick, joined the team as senior director of business operations.

“I’m delighted to continue this journey of implementing real cultural change within the company. Among their responsibilities will be oversight of new operational processes and systems that will improve our ability to deliver on time and in full,” said Pii CEO John Fowler in a press release issued at the time (2). “Every one of these new team leaders is an incredible addition to our company and an important piece of our company-wide strategy to provide best in class services to our partners.”

1. Pii Expands Prefilled Syringe Services with $3.6M Investment in Capacity and Technology Upgrades. Press Release. Nov. 19, 2024. 
2. Pharmaceutics International Onboards New Leadership Team to Drive Quality, Operational Improvements, and Growth. Press Release. March 20, 2023. 

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

Pii Boosts Prefilled Syringe Capabilities with $3.6 Million Investment

Feliza Mirasol is the science editor for 

Abzena announced on Nov. 19, 2024 that it is adding good manufacturing practice (GMP) cell-based potency assay services to  its Cambridge, UK, and San Diego, Calif., development and manufacturing facilities. By now including these services, the company boosts its early and late phase analytical capabilities while enhancing its bioassay offerings. The additional services allows the company to offer more comprehensive, streamlined, and cost-effective ways to access critical data faster (1).

GMP cell-based potency assays play a critical role in the quantitative measurement of biological activity of a biopharmaceutical. These assays are also necessary for assessing the payload cytotoxicity of an antibody-drug conjugate (ADC) (2) for both GMP product release and stability testing. Adding this capability to its toolkit gives Abzena the ability to provide precise and reliable data on drug potency as well as developability and characterization data to elucidate mechanism of action (MOA) and immunogenicity, both essential for regulatory submissions.

“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 [contract research organization] 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,” said Campbell Bunce, PhD, chief scientific officer and Cambridge site head at Abzena, in the press release. “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.”

All services at the company’s Cambridge site are fully integrated with its development and manufacturing services in its US facilities located in San Diego, Calif., and Bristol, Pa.

“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,” said Sean O’Brien, senior vice-president and San Diego site head at Abzena, in the release. “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.”

1. Abzena. Abzena Expands Analytical Capabilities to Include GMP Cell-Based Potency Testing Across US & UK Sites. Press Release. Nov. 19, 2024.
2. Wang, Z.; Li, H.; Gou, L.; Li, W.; Wang, Y. Antibody–Drug Conjugates: Recent Advances in Payloads. 

 (10), 4025–4059. DOI: 10.1016/j.apsb.2023.06.015

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

Abzena Expands Analytical Services with GMP Cell-Based Potency Testing in US and UK

Sanofi has invested €40 million (US$42 million) into its Lyon Gerland bioproduction site in France to boost antibody production. As part of the investment, €25 million (US$26 million) is going toward dedicated production and development of a Thymoglobulin (anti-thymocyte globulin [rabbit]) second-generation product, the company stated in a Nov. 15, 2024 press release. Thymoglobulin is Sanofi's polyclonal antibody for treating transplant patients (1).

Also under the investment, more than €15 million (US$15.7 million) will be put toward internalizing and localizing the preclinical and clinical production of monoclonal antibodies for treating type 1 diabetes in France.

“With this significant investment, we are strengthening our footprint and leadership in bioproduction from France to serve our ambitions in immunology. Our Lyon Gerland site already holds a central place in the Lyon ecosystem of life sciences, and this investment serves as a new step to allow us to accelerate its increased role in serving patients in France and around the world,” said Charles Wolf, general manager France, Sanofi, in a company press release (1).

The company’s polyclonal antibody is an immunosuppressant that is manufactured exclusively at the Lyon Gerland site. Sanofi produces 1.6 million vials of Thymoglobulin at the site to treat approximately 70,000 patients per year in 74 countries (1). In anticipation of the growing number of transplant patients worldwide, the company has developed a new manufacturing process that will increase production capacity for Thymoglobulin, ensure reliable supply, and further improve the product's environmental impact. Modernization work started in the summer of 2024, and the first industrial batches are slated to be produced in 2025 with the first commercial batches expected to be available in 2027.

“Production of this medicine will continue in the meantime and in parallel, according to the process currently in force, which guarantees its availability for patients,” Sanofi stated in its press release.

The bioproduction platform at the Lyon Gerland site is also flexible, allowing the company to internalize production of an immunomodulatory drug for treating unmet need in patients with preclinical type 1 diabetes. This drug, which the company has not named in its release, was previously produced outside the European Union and not by Sanofi. The development of the bioproduction area to produce this drug will begin in early 2025. The first batches are expected to be produced by the end of 2025 and commercial marketing is expected to start in 2027 (1).

Overall, Sanofi has committed more than €2.5 billion (US$2.6 billion) to major projects since the COVID-19 pandemic. In addition, the company has invested more than €1 billion (US$1.05 billion) in bioproduction. The company ensures that 60% of its global production is within the European Union, it stated in its press release.

1. Sanofi. Sanofi Strengthens Antibody Bioproduction in France with an Investment of More Than 40 Million Euros On Its Lyon Gerland Site. Press Release. Nov. 15, 2024.

Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France. 

Featured Content

Digital Transformation in Pharma Manufacturing

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Drug Digest July 2025

Bio/Pharma's Tariff Response