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 

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, Jill Murphy, Editor, talks to Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, about point of care, patient manufacturing, and new innovative technologies in the industry.

, is the Director, Science Staff in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research at the FDA. Dr. Fisher focuses on engaging FDA stakeholders and supporting advanced pharmaceutical manufacturing technologies. At the FDA, he has served as a primary and secondary reviewer of Abbreviated New Drug Applications (generics) and Drug Master Files, a Team Lead, a subject matter expert on complex drug substances and advanced biomanufacturing, and a liaison to the United States Pharmacopeia BIO1 Expert Committee. He joined the FDA in 2014 as a chemical engineer with expertise in the synthesis of biomolecules. Dr. Fisher’s work prior to joining the FDA focused on the microbial production of proteins and glycoproteins. Dr. Fisher was the co-founder and Chief Science Officer of a startup company focused on microbial technologies for the production of glycoproteins. He earned his B.S. degree at the University of Maryland College Park (Chemical Engineering) and his Ph.D. at Cornell University (Chemical & Biomolecular Engineering).

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: FDA Speaks About Near Patient and Continuous Manufacturing 

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

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

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

EMA Recommends Five New Medicines for Approval

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

EMA and HMA Publish Joint Network Strategy to 2028

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.

EMA Recommends Four Medicines for Approval in February

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

According to Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, there are two aspects to consider when assessing the potential impact on industry of the new administration in the United States. “One is a conservative attitude to business, which I think might have some potential positive impact. That's good [because it] will support the economy and give a certain confidence to investment,” he says.

Additionally, Forte specifies that the leadership must impact business positively while also managing to make careful decisions around technological aspects of the industry, allowing organizations, such as FDA, the ability to perform their jobs. “I would also want to see that public health and product considerations are done the right way,” he adds.

A legislative change in the US that will more than likely have an impact on the bio/pharma industry is the introduction of the BIOSECURE Act, which was passed in September 2024. “I can understand some political motivations on how to manage the flow of the data [in relation to the BIOSECURE Act],” Forte says. “Some companies may get impacted, not only the ones that are directly targeted by the BIOSECURE Act, but also the ones that had deals and partnerships and collaborations with those companies, they will have to readjust their businesses again.”

Looking at industry regulations in more detail, Forte specifies that FDA has been keen on engaging in discussions about cell and gene therapy and becoming more comfortable with these novel modalities. “I believe that regulators [are] in a much better position today to make the right decisions and support the field in terms of the development [of cell and gene therapies], and that will translate in legislation, for sure, as well,” he adds. “I think, from a new technology point of view, we saw some good decisions in terms of reimbursement into the US recently, which I think is a good signal to the field.”

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.

Videos

PharmTech News

Business News

In an interview with Pharmaceutical Technology®, Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.

Industry Outlook 2025: Consolidating Data and Relaxing Regulations on AI

As the technology agenda progresses for industry, Mike Baird, director of product management for Schlafender Hase, a German software company, expects the primary impact of advanced tools to happen in the compliance space. “AI [artificial intelligence] is a very generic term,” he emphasizes. “But machine learning and large language models in particular are going to be at the forefront of this [trend], because that's where all the data can be consolidated.”

However, the transition to automated and digital-led processes will not happen overnight, Baird asserts. “[These tools] are like babies, and we have to teach them how to do things,” he says. “And so, once the teaching is in place, and once we get the models trained, then they can really help in this area of compliance and adhering to regulations.

Looking at the potential M&A activity for industry over the coming 12 months, Baird anticipates that if interest rates continue to go down, then we should be looking at a more favorable landscape in the near future. However, the change in government administration in the United States also leads to a little bit of uncertainty, he adds.

The new administration may lead to some challenges, particularly around drug pricing, Baird speculates. “[But], going back to the technology side of things, one thing that I'm not certain of, but I think might be a good prediction, is that there'll be a relaxation in the regulations surrounding AI,” he notes. “I think this administration is a big supporter of technology, which is great, but also a big supporter of AI, and where that can take us, and what that can do for the for the industry.”

Mike Baird is Director of Product Management for Schlafender Hase—a German software company. Mike’s role is to develop software to meet and exceed the needs of customers. He has more than 25 years of experience working with global packaging, labelling, pre-media, and artwork management leaders in the pharmaceutical and medical device sectors.

Sustainability in Pharmaceutical Manufacturing

The pharmaceutical industry has been moving toward more environmentally friendly practices over the past decade. Regulators have also created sustainability requirements, especially in Europe.

“European regulations are particularly stringent on emissions and product lifecycle sustainability, and they have guided a lot of our initiatives such as a co-design, or carbon offset partnerships,” says Charles Ruban, president and CEO, Verdot.

Both small-molecule and large-molecule drug manufacturing have their own challenges, according to Ruban. Biopharmaceutical manufacturing is energy-intensive and creates material waste during production. Ruban says Verdot approaches the challenges of sustainable biopharmaceutical manufacturing by designing energy-efficient equipment that optimizes the use of material.

“We're partnering with suppliers committed to systemic sustainability, so our carbon-neutral initiative reflects the commitment of overcoming those models while enabling appliances to globally reduce their environmental footprint,” says Ruban.

Click the video above to watch the interview.

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

Continuous production has been employed across many industries for some time to improve efficiencies, reproducibility, and quality. For the bio/pharma industry, continuous processes have come a long way, although semi-continuous is still more widely adopted.

“I think, of late, [continuous processing has] come a long way,” asserts Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology. “We're still seeing there aren’t that many full continuous processes out there, but we do see a lot more semi-continuous processing. So that's where you're sort of combining two or maybe three processes together, and that that may be to start with, in terms of stacking them up, allowing the continuous process of material going from one process into another.”

Additionally, with the advent of more robotics, particularly in a cleanroom space, there is scope for companies to remove the operator from certain aspects of the process, which is helping to reduce risk, Dunne confirms. “Placing a robot into the process stream removes the operator, and that's the best thing you can do, from a containment perspective,” he says. “You have less risk for the operator, but you also have a vast improvement on the product quality as well. We do know from a microbiological perspective that generally it's the operator which is the most contaminating source on the process. So, if you can get [the operator] out of there, you've improved both the containment from the operator perspective, and also the product quality as well.”

Automation and reducing potential contamination are common threads throughout the European Union good manufacturing practice (GMP) Annex 1 guidance document, Dunne notes. “It's kind of a theme that's running through the whole of that document, isolating the operators from the process,” he says. “We're seeing lines now that are almost completely autonomous. And I think that [more automation is] going to be something that's going to come in the not-too-distant future.”

Christian Dunne is director of Global Corporate Business Development at ChargePoint Technology—a pharmaceutical containment and aseptic processing specialist company. Christian has worked in the bio/pharma industry for 20 years covering oral solid dosage manufacturing through to sterile processing and fill/finish manufacturing.

AAPS PharmSci 360 2024: How AI is Helping to Ensure Companies' GMP Health

As part of its AAPS PharmSci 360 2024 coverage, 

 interviewed Jerry Chapman, senior good manufacturing practice (GMP) quality expert with Redica Systems, about his presentation at the conference, “Using AI to Evaluate GMP Health of Drug Manufacturing Sites,” to be delivered on Tuesday, Oct. 22, 2024. Chapman discussed the importance of determining GMP quality risks for any company, and how artificial intelligence (AI) is now assisting Redica in facilitating these evaluations.

“What we have done is, we've built something called an ontology, and the ontology is really, for lack of a better analogy, it’s like a dictionary of terms and what they mean with our industry,” Chapman says in the interview. “So, if you went to ChatGPT and asked it about an API, it would think you were talking about an application program interface. In the ... wide world, if you will, that that's what people would equate that to. In the pharmaceutical industry, it is an active pharmaceutical ingredient, right? So, we have to spend a fair amount of time training the AI on our ontology and being able to train it so that it can recognize those terms and be able to ferret them out in inspection documents.”

Click the above video to watch the full interview.

Chapman’s presentation will be at 10:30 a.m. MT on the 22nd, in Room 155E. AAPS PharmSci 360 is being held from Oct. 20–23, 2024 in Salt Lake City, Utah.

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

Latest Conference

AAPS PharmSci 360 2024: How AI is Helping to Ensure Companies’ GMP Health

CPHI Milan 2024: Pharma Developments in Emerging Markets

 sat down with Rafael Ferrer, interim chief business officer at Acino, to talk about expansion into emerging markets, such as Latin America. Acino has been concentrating recent efforts there, in Africa, and in the Middle East, and Ferrer says the new drug pipeline often doesn’t extend to these areas.

“A large part of what we're trying to do is really be able to bring access to innovative drugs to patients in these geographies today,” Ferrer says. “If you look at the data, more or less, of 100 or so products that have been launched in the last 10 years, let's say novel molecular entities, be it new chemical entities or new biologic entities, only about 10% to about 30% of those ever make their way to emerging markets. So, there's a significant gap in terms of access to novel therapeutic modalities and novel medicines across our geographies. And for us, we see it as a mission to be able to improve access to novel medicines, while at the same time, of course, continuing to provide, you know, high-quality, well-known, well-proven brands, which are a large part of our portfolio.”

Ferrer also talked about the pitfalls of the regulatory landscape when it comes to these markets.

“The regulatory complexities and realities of Brazil are not the same as those of South Africa or the ones in Kuwait or the UAE, right?” he says. “So, we have to take that into consideration. I think [we] at Acino are very well positioned in the sense that not only do we have in-market teams that truly understand the local regulations and are able to work with regulators, with the regulatory bodies, to understand what are the pathways of getting new drugs, new medicines, to market across those markets, but also are really uniquely positioned to be able to execute on that, with the overall support that we have behind the corporation that we built.”

 is being held from Oct. 8–10, 2024 in Milan, Italy.

Rafael Ferrer, interim chief business officer at Acino, talked about his company's recent efforts to reach customers in Africa, the Middle East, and most recently, Latin America.

Regulatory Oversight

Latest News