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

Felicity Thomas

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, director of Global Corporate Business Development at ChargePoint Technology.

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.

Videos

In an interview with Pharmaceutical Technology Roger Viney from ICE Pharma highlights the importance of sustainability for the bio/pharma industry and some important future considerations for companies.

Creating a Sustainable Approach

Sustainability in the pharmaceutical industry has increased in the past few years as a significant initiative for regulators and many pharmaceutical companies. Sustainability practices may include investment in renewables, zero emission buildings, and greener manufacturing practices (1). ICE Pharma has adopted a sustainability strategy that includes fighting illness through product innovation, caring for people, accelerating sustainable operations, and building strong relationships (2).To gain more perspective on sustainability in pharma, 

spoke withRoger Viney from ICE Pharma about what pharmaceutical companies should consider when developing a sustainability strategy.

Viney stresses that the healthcare industry, which is responsible for approximately 5% of global emissions, must be aware of the impact the industry has on the environment. “I think it's important to recognize that what we manufacture is biologically active,” says Viney. “So, in that case, it has a bigger environmental impact than some other products. I think in terms of the regulations that we have to comply with, you know, or the quality compliance regulations, I think the pharma industry is relatively slow to change, and we're slow to introduce new manufacturing technologies. We have difficulty adapting to new technologies which would lower our environmental impact. So, I think we've been slower than we would have liked. It's the nature of our industry. But I think, of course, there's a very big expectation from our customers, whether it be governments, businesses, or patients, that we do make progress in this area.”

Sustainability in the Pharmaceutical Industry

 (accessed Dec. 16, 2024). 
2. Lavery, P. 

ICE Pharma Touts Fully Recyclable Booth at Its CPHI Milan Exhibit

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

Pharmaceutical Technology chats with Roger Viney from ICE Pharma about bile acids in detail, including how they are useful in helping to improve drug solubility and absorption.

Improving Solubility and Bioavailability with Bile Acids

Poor solubility and bioavailability are becoming increasingly problematic for drug developers as more complex molecules are entering the development pipeline. “Bile acids are nature’s surfactants, their primary role is to promote the absorption of fat-soluble nutrients,” says Roger Viney, PhD, chief commercial officer for ICE Pharma—a bile acid expert. “So, depending on the bile acid, you can vary the hydrophilic lipophilic balance [and] improve bioavailability of poorly soluble drugs.”

“Furthermore, the bile acids can play a role as enhancer of permeability,” Viney continues. “[Bile acids are] able to modulate the cell membranes to allow certain drugs to cross the biological barriers more effectively. So, we have examples today, existing examples of oral and injectable applications formulations that use bile acids as excipients, and we are expecting to see this expand into things like transdermal and even nasal applications.”

Bile acids have been used in traditional forms of medicine for thousands of years; however, they did not enter modern and Western medicines until the 1960s, Viney notes. “The past 20 years have seen a very significant amount of research done into bile acids and their recognition that they're more than nature's surfactants, that they're, in fact, signaling molecules that have metabolic function,” he adds. “And so, this kind of research has opened up a whole new field where bile acids can potentially treat oncology, liver diseases, even neurodegenerative diseases.”

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about artificial intelligence (AI) and the potential impact AI and machine learning may have on the global bio/pharma industry in the near future.

 is chief scientific officer for Biorelate—an AI platform company that provides data solutions to pharma companies

 is CEO of Qinecsa Solutions, which is a UK headquartered but international pharmacovigilance technology and services solution provider.

 is vice president of Regulatory Quality and Compliance, Arriello—a life sciences consultancy.

 is CEO of Autolomous, which uses smart technology to help ATMP manufacturers.

is COO of Unbiased Science and vice-president of the Medical Information Leaders in Europe (MILE).

 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

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Drug Solutions Podcast: Realizing AI’s Potential 

Pharmaceutical Technology sits down with Christian Dunne from ChargePoint Technology to discuss the key processing equipment trends in the bio/pharma industry.

A Greater Need for Containment: Processing Equipment Trends

Over recent years, the bio/pharma industry has experienced a variety of trends, such as an increasing prevalence of more complex molecules in the development pipeline, smaller batch sizes being manufactured, and a greater need for containment, which have led to new approaches and technologies being explored for manufacturing and development. For processing equipment in particular, Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology, believes that the increasing levels of containment have had the biggest impact.

“In part, [the changing levels of containment are] probably because of the better bioavailability of some of the drugs that are coming through, the doses seem to be a little bit smaller, and so we're getting much higher potency in what we're seeing in the industry than we used to many years ago,” Dunne says. It was more commonplace to see containment levels of one to 10 micrograms per cubic meter in the past, whereas now, more often than not, the industry is seeing less than a microgram and even into the nanogram levels of containment, he explains.

“Certainly, automation is very impactful on the industry at the moment, and that sort of rolls into robotics,” Dunne continued. Primarily, robotics were introduced into fill/finish operations, he notes, but now they are also being seen in oral solid dosage (OSD) technology as well, linking various (OSD) steps together.

Additionally, single-use technology is a key trend shaping processing equipment, Dunne specifies. “Obviously, you get a lot of flexibility with the single-use technology, and a lot of reduced risk in terms of the operator protection. But of course, it's got the added advantage of cost being a main driver for a lot of the companies like CMOs [contract manufacturing organizations].”

In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development and manufacturing. 

Focusing on Solid Dosage Trends and Demand

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews Dr. Ali Rajabi-Siahboomi from Colorcon about solid dosage drug development and manufacturing. During the discussion, Dr. Ali will provide an overview of the solid dosage drug development and manufacturing sector, factors driving growth in the market, challenges facing companies and the shifts in demand, the evolution of coating design, and regulatory considerations impacting oral solid dosage development and manufacturing.

Ali Rajabi-Siahboomi is the vice president and chief innovation officer at Colorcon, based at the Global Headquarter, USA. Rajabi-Siahboomi has held various academic positions in Nottingham and Liverpool JM Universities in the UK before joining Colorcon as technical director, responsible for Europe, the Middle East, and Africa in 2000. His main research interests are solid dosage form pharmaceutics, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailability, and consistency of drugs and bioequivalence formulations. He has published more than 300 articles, book chapters, abstracts, and patents and obtained his B.Pharm. and PhD in pharmacy from the University of Nottingham (UK).

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

 Emerging Therapies and Targeted Delivery

 Advances in Small-Molecule Manufacturing

Felicity Thomas

Articles