Bio/Pharmaceutical Analysis Techniques

Laboratory Equipment and Instruments

Analytics

Deals, Development and Manufacturing

Inhalation Drugs

Parenterals and Injectables

Solid/Semi-Solid Dosage

Specialty Dosage Drugs

Dosage Forms

APIs and Excipients

Formulation and Drug Delivery

Ingredients

Intellectual Property and Patents

Process and Scaling

Drug Development

Global Perspectives

Intellectual Property & Patents

Aseptic/Sterile Processing

Data and Artificial Intelligence

Equipment

Manufacturing, Biologic Drugs

Manufacturing, Biosimilars and Biobetters

Manufacturing, Cell Therapies

Manufacturing, Gene Therapies

Manufacturing, Inhalation Drugs

Manufacturing, Parenterals and Injectables

Manufacturing, Solid and Semi-Solid Dosage Drugs

Packaging and Distribution

Process and Automation

Supply Chain

Manufacturing

Mergers and Acquisitions

Contract Analytical Services

Contract Development Services

Contract Manufacturing, General

Contract Research Services

Logistics and Distribution

Regulatory Consulting

Outsourcing

Quality Assurance/Quality Control

Regulatory Oversight

Regulatory Oversight and Compliance

Quality Systems

News

Business

Bio/Pharma Business

All News

Top News

Industry News

Bio/Pharma News

Supplier News

News from Europe

Publications

All Publications

PharmTech

PharmTech Europe

Resources

Marketplace

Front & Center

ICH Q9 Revision: A Comprehensive Resource on Quality Risk Management

Peer-Reviewed Research

PharmTech Products

Pharma Insights

Whitepapers

Webcasts

Multimedia

All Videos

Ask the Expert

Behind The Headlines

Buy, Sell, Hold

Drug Digest Videos

Drug Solutions Podcast

Peer Exchange

Sexy Science

Tech Talk

Conference

Conference Coverage

Conference Listing

Events

Subscribe

Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.

About Us

Advertise

Contact Us

Editorial Info

Editorial Advisory Board

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Technology

Twitter

LinkedIn

Spotlight

Topic

COVID-19 Update

APIs

Analytical Method Development

Aseptic Processing

Biologic Drugs

Drug Delivery

Excipients

Formulation

Packaging

Process Control/PAT

Process Development

QA/QC

Regulatory Action

1rem

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with Hanns-Christian Mahler, CEO and board member of ten23 health, about the growing demand for fill/finish services, technological advances and novel approaches helping to advance fill/finish, sustainable and green practices, the impact of smaller batch sizes, and regulatory guidance updates in the space.

 holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He previously worked for Lonza, Roche, and Merck, and currently serves on the boards of Bionter and KriyaBio. Hanns-Christian is also an editor for several pharmaceutical journals.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish 

 podcast, Felicity Thomas, European/Senior Editor, chats with Alexander Natz, Secretary-General of EUCOPE, about the European Health Data Space (EHDS), which was formally adopted by the European Parliament in April 2024. The EHDS aims to improve individual’s the access to and control of their own health data and also to allow for the secondary use of health data in research, innovation, policy-making, and regulatory activities.

 is Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). As Secretary-General, Alex advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing and reimbursement matters from the European Union law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alex has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Podcast will give an overview of the biosimilars market. Industry experts will discuss regulatory controls, pricing pressure, the state of the healthcare industry, and other factors affecting the uptake of biosimilars in the market. Manufacturing challenges as well as current and future needs will also be discussed. Experts will also highlight technological innovations, such as digitalization technologies, and their role in facilitating analytical characterization and manufacturing controls for biosimilars.

Zara Bukhari, PhD student, Biochemistry, University of the Pacific, Stockton, California

Zara Bukhari completed a master’s degree in engineering at Birla Institute of Technology and Sciences, India, with an internship at Biocon Biologics, focusing on Semglee (insulin glargine-yfgn). This experience sparked Bukhari’s interest in the pharmaceutical industry. Subsequently, she worked as a bioprocess engineer at Biocon Biologics for six years, contributing to the design of purification platforms for biosimilars and innovator biologics. Notably, she was involved in a validation study leading to the successful biologics license application filing of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), offering her insights into regulatory requirements and the biosimilars market. Bukhari is currently pursuing a PhD in biochemistry, specializing in ubiquitin biology at the University of the Pacific, Stockton, Calif. Through her PhD, Bukhari aspires to contribute valuable insights into the role of ubiquitination in regulating the cellular proteome and its broader implications in diseases to advance scientific understanding and potentially aid the scientific community in identifying novel drug targets.

John Gabrielson, Senior Vice-President, Biosimilars, and Head of Business, JSR Life Sciences

John Gabrielson is senior vice-president, Biosimilars, and head of Business for JSR Life Sciences. He is a seasoned executive, company builder, and strategist with nearly 20 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading contract development and manufacturing organization, Gabrielson is now focused on accelerating biosimilar adoption across the industry.

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the 

Podcast will discuss the realities of switching over from manual to digital, and what to expect.

Ajit Yeole, senior director, Life Sciences Manufacturing, Cognizant

Ajit Yeole is the senior director for Life Sciences Manufacturing at Cognizant, based in London, UK.He is responsible for strategy, smart manufacturing, developing new service offerings, and digital accelerators targeted towards addressing the industry needs. Has been closely working on engagements around manufacturing and quality involving emerging technologies (Industrial IoT, advanced analytics, AR/VR , and others) using agile and design-thinking-led approaches. He has led the manufacturing operations management practice for Cognizant in Europe and has delivered large manufacturing programs while collaboratively building tools and templates for consulting offerings. Previously, he worked in manufacturing operations management, IoT (M2M) and OT/ industrial automation as a consultant, solutions architect, and business unit head.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte

Laks Pernenkil, PhD, is a principal in Deloitte’s Life Sciences Product, Supply, Manufacturing and Quality Operations practice based in McLean, Va. He has more than 15 years of consulting and technical operations experience in pharmaceutical, biologics and medical device sectors. At Deloitte, his experience includes smart/digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence, and market entry operations strategy.

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

Drug Solutions Podcast: Digital Transformation in the Biopharma Industry

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to David Tisi, technical director at Senopsys LLC, and Reenal Gandhi, global business development director for the Prescription Division of 

. In the first segment of the episode, David chats about some of the key challenges impacting oral dosage forms and the approaches and solutions available that are helping developers overcome these hurdles. After, Reenal details the intricacies of intranasal drug dosage forms, such as the convenience and the growth of this route of administration, challenges of development, and the possibilities of repositioning drug products.

David Tisi, technical director at Senopsys LLC

David is founding member of the scientific team at Senopsys LLC, a specialty services firm dedicated to the development of palatable drug products. He has over 15 years of experience in taste assessment and taste masking novel drug formulations for children and adults, leveraging his background in sensory science and food chemistry. David received his Masters in Food Science from Cornell University and began his career in product innovation at PepsiCo and Nestle.

Reenal Gandhi, global business development director for the Prescription Division of 

Reenal has more than 15 years’ experience within the drug delivery and pharmaceutical industries, involved in the development and commercialization of wide-ranging drug delivery solutions. Over the course of her career, Reenal has actively worked on business development related to nasal and injectable devices, such as prefilled syringes and autoinjectors. Since December 2020, Reenal has been working for Aptar Pharma, driving the assessment of new opportunities and focusing on new technologies in particular.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

Drug Solutions Podcast: Innovations and Advances in Drug Dosage Forms

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, catches up with Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the acceptance of a novel excipient onto CDER’s pilot review program, the next steps involved in progressing an excipient through the review program, and the change in industry’s mindset toward review programs in general.

Ana L. Ladino is Ashland’s Global Director-Regulatory Affairs

. As senior leader of the regulatory affairs function, she manages strategic direction and operational oversight for the regulatory activities for all Ashland’s Life Sciences products: excipients and other oral solid dosage ingredients and coatings, injectables, nutrition, nutraceuticals, agrochemicals, and medical devices. She oversees all FDA and other global regulatory authority interactions for Ashland’s products while ensuring a high level of integrity in regulatory and quality compliance. With 25 years of experience in the healthcare industry, she has extensive experience in drugs, combination products, medical devices, excipients, and API regulatory requirements. She has been involved in industry organizations such as RAPS, IPEC, AAM, ISO, NEMA, authored many global regulatory-related papers, and presents worldwide on various regulatory topics. She served on the Healthcare Businesswomen’s Association (HBA)—West Chester Board.

Ana holds a bachelor’s degree in electrical engineering and a master’s degree in biomedical engineering from Autonomous University of the West (UAO), in Cali, Colombia. In the past, she has worked for West Pharmaceuticals, Accellent, Siemens, GE Medical, and as a university professor.

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Drug Solutions Podcast: Progressing Excipients Through Review


In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the role of novel excipients in drug development. Ana highlights the importance of novel excipients in the advancing drug development pipeline, gives an overview of CDER’s pilot review program, discusses potential changes to regulatory approaches in other regions, and provides an overview of best practices for companies to follow when dealing with novel excipients.

Ana L. Ladino is Ashland’s Global Director-Regulatory Affairs.

As senior leader of the regulatory affairs function, she manages strategic direction and operational oversight for the regulatory activities for all Ashland’s Life Sciences products: excipients and other oral solid dosage ingredients and coatings, injectables, nutrition, nutraceuticals, agrochemicals, and medical devices. She oversees all FDA and other global regulatory authority interactions for Ashland’s products while ensuring a high level of integrity in regulatory and quality compliance. With 25 years of experience in the healthcare industry, she has extensive experience in drugs, combination products, medical devices, excipients, and API regulatory requirements. She has been involved in industry organizations such as RAPS, IPEC, AAM, ISO, NEMA, authored many global regulatory-related papers, and presents worldwide on various regulatory topics. She served on the Healthcare Businesswomen’s Association (HBA)—West Chester Board.

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Drug Solutions Podcast: Novel Excipients in Drug Development

Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Director of FDA’s Office of Pharmaceutical Quality, Michael Kopcha,deputy director of science, Sau Lee, anddeputy director of operations, Cindy Buhse, join Chris Spivey, editorial director, for a discussion about:

The framework for regulatory advanced manufacturing evaluation (FRAME)

Quality as a co-dependent variable of economic outcome

Advanced versus traditional manufacturing

Pandemic pressures and improved communication

Keeping up with biotech and emerging therapies

Re-shoring drug manufacturing to the United States

What manufacturers need to understand about advancing pharmaceutical science


, PhD, R.Ph., is the director of FDA’s Office of Pharmaceutical Quality (OPQ). This office has more than 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of investigational new drug applications (INDs) and establishes quality standards for over-the-counter drug products and facilities. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science and a bachelor’s degree in pharmacy from Rutgers University. He served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

, PhD, is the deputy super office director of science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions (OBP, OLDP, ONDP, and OPMA). He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, the Center of Drug Evaluation and Research (CDER), and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. Prior to joining FDA, Dr. Lee received a bachelor of science degree in chemical engineering from the University of Virginia with a minor in materials science and a PhD in chemical engineering from Princeton University.

is currently the acting senior advisor for scientific operations in the OPQ in the CDER in the FDA. Dr. Buhse joined FDA in 2001 in OPQ’s office of testing and research. She was the director of the office of testing and research from 2013 to 2017 and the director for the office of quality surveillance (OQS) from 2017 to 2019. Before joining FDA, Dr. Buhse worked in management positions in production, validation, and analytical services at Sigma Aldrich Corporation and as a senior research scientist for Rohm and Haas Company. Dr. Buhse received a B.A. in chemistry from Grinnell College and a PhD in physical chemistry from the University of California, Berkeley. OQS assures that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Counterfeit pharmaceutical products are a global issue that impacts all stakeholders in the pharma industry and poses a potentially lethal threat to patients. Globally, measures have been put in place to help tackle the problems posed by counterfeit medicines; however, as the United Kingdom is now no longer a part of the European Union, concerns have been raised that the country could be left exposed to an increased prevalence of counterfeit medicines infiltrating the market.

Anti-counterfeiting measures are expected to become stricter in the future to ensure patients are protected and with the rising levels of data that will be required to be managed and processed, blockchain could offer a suitable solution to industry. To learn more about the issue of counterfeit medicines and the potential benefits that can be gained from using blockchain as an infrastructure technology, 

 spoke with Raja Sharif, CEO and founder of FarmaTrust—a provider of blockchain and artificial intelligence (AI) provenance systems for the pharmaceutical and healthcare sectors.

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Tackling Counterfeit Medicines

The QbD initiative is driving pharmaceutical chemists, formulators, process developers, and manufacturers to come to a better, more detailed understanding of the characteristics of the ingredients they’re working with and how those ingredients behave during different phases of the manufacturing process. Many of these ingredients are powdered solids, and scientists are trying to learn what they can about the characteristics of their constituent particles. This is no easy task.

Editor-in-Chief Michelle Hoffman talks to Tim Freeman, Director of Operations at Freeman Technology, about the industry’s current level of understanding about powder characteristics and dynamics.

Podcast: Powder Dynamics and QbD

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Bayer Announces FDA’s First Full Approval of NTRK Inhibitor

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

BDD Opens GMP Manufacturing Facility in Scotland

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Microsoft and SkyCell Collaborate on Pharma Supply Chain Logistics

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.


Navigating the Complexities of Emerging Therapy Development

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

Enhancing Solubility and Bioavailability with Nanotechnology

Alexander Seyf, CEO and Co-Founder of Autolomous

Alexander Seyf, CEO and co-founder of Autolomous, sees the advancement of artificial intelligence (AI) and machine learning (ML) as tools to support pharmaceutical scientists and manufacturers in their work.

“AI and ML can help us to do the leg work, but the main work is going to need to be done by our own brain, but by human being,” Seyf insists. “I think it will be more segregation of mechanical work rather than intellectual work. And for identifying the progression of biology and the discovering the different solutions for different diseases, you've seen an amazing trend today. There are companies in the United States that we're looking at using off-the-shelf drugs for different indications that it was not intended from beginning. And I believe that's a huge, huge progression in the right direction. And for drug discovery, we're going to look at cross fertilization, of what we have already enhanced for the solution to the diseases that we don't have any treatment for. So, we will see examples of that practically, ML and AI can help us to progress the pharma and other industries, for that matter, more in the right direction.”

Click the video above to watch the full interview.

Alexander Seyf is CEO and Co-Founder of Autolomous.

Videos

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

PharmTech News

PharmTech Videos

Industry Outlook 2025: Technology as a Supporting Element

Industry Outlook 2025: Talent Up for Grabs

The post-COVID-19 era has seen the consequences of ambitious programs launched during the pandemic, according to Erik Wiklund, CEO of Circio, such as a lack of capital for small biotech and employee layoffs, and Wiklund sees this impacting the industry during 2025. “Many companies launch great ambitions, large valuations. People flow into the industry, and then the breaks set in, but then what happens is that the companies that survive, they then suddenly have access to a broad talent pool, and then the capital comes back,” Wiklund says. “So, I think the consequence of that is that you see some consolidation. You see access to talent, and you see new stronger companies emerge, and maybe that's what will happen now. After the reset in biotech, a broad set of companies are gone, but this may create fertile ground for the future successes once the capital markets and the industry start to normalize, and hopefully this will happen during 2025.”

This increase in available talent is a trend that Wiklund sees continuing in the coming year. “What we've seen is that there's been increasing cost levels in the [United States] in particular, strong dollar and increasing inflation has driven up prices,” Wiklund says. “Salaries are high, and I think that, to a certain degree, is starting to make European or other companies look elsewhere for development opportunities. It's become cheaper by comparison to develop drugs in Europe, Asia, and Australia, and I think maybe if that trend continues with a strong US economy and increasing prices, then you may see that kind of European, eastwards-oriented trend continuing.”

Click the above video to watch the interview.

Erik Wiklund, PhD, is CEO of Circio. He has deep scientific knowledge in RNA and cancer biology, and 13 years of pharma and biotech industry experience in a variety of functions including R&D, finance and business development. Previous employment includes the radiopharmaceutical company Algeta, which was acquired by Bayer in 2014, Aker Biomarine, and management consulting experience from the Pharma & Health Care practice of McKinsey & Company. Wiklund holds a PhD in Molecular Biology from Aarhus University, Denmark, and the Garvan Institute of Medical Research, Sydney, Australia

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

Quality Systems

Latest News