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

Felicity Thomas

CPHI Milan 2024: Compliance and Automation in Aseptic Processing

It has been a little over a year since the European Union’s Annex 1 revisions came into force (1), meaning that companies manufacturing sterile medicinal products should be compliant with the new version of the regulatory guidance. However, the road to compliance for any regulatory change is often fraught with challenges, and for Annex 1, Klaus Ullherr, senior product manager at Syntegon, highlights two in particular that he has encountered as a machine builder.

The first challenge to overcome is that of maintaining clean air, so, ensuring that the air flowing down from above onto the machine does not come into contact with anything prior to reaching the product, Ullherr notes. “The second [challenge],” he continues, “is the aseptic setup, meaning that you now have to have autoclave parts.”

A key aspect helping to overcome challenges and ensure compliance is employing more automated solutions in the aseptic processing line. Automation also reduces human intervention, which is critical as humans pose a huge threat to product quality through potential contamination, Ullherr asserts.

Furthermore, automated systems allow for processes to be performed completely reproducibly, Ullherr continues. “We know from presentations from FDA that many deviations within pharma are caused by human error,” he summarizes. “The automation of processes really gives us the opportunity to reduce these deviations significantly.”

Annex 1 Manufacture of Sterile Medicinal Products

Visit Syntegon at Booth 18C33. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

Klaus Ullherr, senior product manager, Syntegon

Klaus Ullherr is a senior product manager at Syntegon with a University degree in electrical engineering. Before joining Syntegon in March 2000, he worked as a project manager in the electrical industry for several years. At Syntegon, his main responsibilities include global product responsibility, market analysis, and initiating new product developments. He is a member of the PDA and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a well-known speaker and trainer covering trends and solutions for fill/finish equipment.

Videos

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

CPHI Milan 2024: Trends in Oral Solid Dosage Forms

 sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments.

Hanenberg sees the oral solid dosage market growing, in part by the aging population, as well as a trend toward reducing the number of suppliers and the creation of strategic partnerships. Oral biologics are a popular development in the industry, because of the easy method of administration, as well as the push for continuous manufacturing processes, according to Hanenberg.

Investment will continue in the oral solid dosage market, according to Hanenberg, pointing out the popularity of glucagon-like peptide-1 (GLP-1) diabetes and weight loss drugs. “There will come further big products. And that is certainly not to be executed on an existing tablet line or blister line,” says Hanenberg. “That is something where you need more investment … I expect to see announcement on investment in high-potent capabilities, especially in CDMO [the contract development and manufacturing organization] space, anything that is related to completion of offerings to reach an integrated solution, which means I expect a further consolidation of the CDMO market. Then I expect a very significant investment in continuous manufacturing. There are big companies who have a commitment to produce, in future, 50–80% of all new launches on continuous manufacturing.”

Click the above video to watch the full interview.

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

Uwe Hanenberg, Head of Product Implementation, Oral Solid Dose


Dr. Uwe Hanenberg is Head of Product Implementation, Oral Solid Dose (OSD) at Recipharm. Uwe is responsible for implementing and executing the OSD Product Development strategy that assures science driven, timely development of new products or services. Uwe has 25 years of experience in the pharmaceutical industry with Bayer, Altana, Grünenthal and Catalent. He has held several leading positions in quality, manufacturing and packaging, product development, project management within the Science & Technology sphere. His areas of expertise are oral formulation development, oral manufacturing technologies, stick pack technologies and pharmaceutical contract services and project management.

Pharmaceutical Technology Europe sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments. 

Keeping up to date with the latest regulatory and pharmacopeial guidelines and revisions is always in the best interest of a pharmaceutical company throughout all aspects of its business. In terms of pharmaceutical packaging, there are important standards and guidelines for companies to follow, not only to ensure the safety and efficacy of the medicines housed within their packaging, but also to protect and assist the patient.

“Compliance trends in the pharmaceutical packaging sector are constantly evolving but CRSF [child-resistant senior-friendly] packaging has long been a major concern,” stresses Olivier Rousseau, CEO, SGD Pharma. “In the United States, over 300 children under the age of 20 are treated in the emergency department every day, and two die as a result of unintentional poisoning (1). And in the European Union, it is the fifth leading cause of accidental death for children and adolescents. Most cases occur within the home, when children gain access to harmful substances that are improperly stored.”

While the ultimate responsibility lies with parents or carers of children to ensure medications are not erroneously consumed, pharmaceutical packaging manufacturers are also being tasked with providing packaging solutions that are child-resistant while also being as user-friendly to adults and senior citizens as possible, Rousseau explains.

“There are numerous mechanisms for child-resistant closures (CRC) on medical packaging, which are primarily categorized into re-closable (bottles) or non-re-closable (blister packs),” Rousseau continues. “In some countries, pharmaceutical and healthcare companies are required by law to produce packaging that is child-resistant, while maintaining accessibility for the consumer.”

For example, Rousseau points out the standard test procedure, published by the International Organization for Standardization, for re-closable child-resistant packaging (2). And, in Europe, he notes, several norms have been introduced that complement the ISO standard.

“Pharmaceutical companies must have certification of child resistance for the for their full solution and the time and cost related to this is significant,” Rousseau stresses. “To streamline this, drug manufacturers can partner with packaging manufacturers that can not only supply innovative, high-quality packaging, but also provide the required certification (ISO 8317:2015 in Europe and 16 

1. ChildCare Aware of America. Poisoning. 

https://www.childcareaware.org/our-issues/crisis-and-disaster-resources/poison/

Child-Resistant Packaging—Requirements and Testing Procedures for Reclosable Packages

Felicity Thomas is associate editorial director for 

Articles

Important standards and guidelines for packaging protect and assist the patient.

Age Considerations for Pharmaceutical Packaging Compliance

Securing the Supply Chain for Small-Molecule APIs and Excipients

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

Group, interviews experts about small-molecule APIs and excipients. During the first segment of the interview, Kevin Webb, Chief Operating Officer of the API Innovation Center delves into the trends driving change in the small-molecule API space, the importance of supply chain resilience and approaches being used to secure small-molecule API supply chains, the benefits of advanced manufacturing approaches in reshoring, the hurdles facing reshoring efforts, and potential future trends that may impact the small-molecule API space. Next up, Nigel Langley, Global Technical Director, Life Sciences, Gaylord Chemical Company, goes into detail about supply chain security for excipients, the potential impact of using non-compendial materials in a formulation, and some best practices that should be employed to ensure that no adulterated and non-compendial materials enter drug development processes. Additionally, he provides a teaser as to what viewers can look forward to at an upcoming panel discussion, taking place at CPHI in Milan.

Kevin Webb is the Chief Operating Officer of the API Innovation Center where he has direct responsibility for business operations, programs, strategy and external engagement. He leads the API Innovation Center’s efforts at a national and regional level to strengthen domestic pharmaceutical manufacturing in the U.S. and is a subject matter expert and featured speaker on the importance of securing our national health security.

Kevin brings 30 years of experience in the healthcare industry with broad, cross-functional technical expertise in government affairs, communications, manufacturing, operations, sales and brand management. He is a highly respected and trusted representative of the pharmaceutical industry.

Prior to the API Innovation Center, Kevin held leadership roles at Mallinckrodt Pharmaceuticals, Sanofi Pasteur Vaccines and Memorial Medical Center, a tertiary health center in Central Illinois. He holds an MBA from the University of Illinois and a Bachelor of Science from St. Louis University.

Nigel Langley, Global Technical Director, Life Sciences, Gaylord Chemical Company LLC, provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (liquid crystals) from the University of Hull (UK) and an MBA from Leeds University (UK). He also took a 2- year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co- edited 3 books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC- Americas since 2010 and is currently Chair.

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.

 Solid Dosage Development and Manufacturing

 Emerging Therapies and Targeted Delivery

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, Pharmaceutical Technology Group, interviews experts about key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains.

Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients

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Artificial intelligence (AI) has rapidly become an aspect of everyday life, ranging in use from simple tasks, such as asking a personal assistant a question on a phone, to more complex tasks, such as analyzing vast swathes of data. For the bio/pharma industry, the use of AI and machine learning (ML) has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.

This article was published in the October 2024 print issue of 

A survey performed by the Pistoia Alliance and Open Pharma Research, the results of which were presented at the Lab of the Future Congress on 1–2 Oct. 2024, has found that a greater proportion of the global R&D community are adopting AI and ML as compared to 2023. However, while adoption rates are on the rise, other concerns are coming to the fore (1).

According to the survey results, 68% of the 200 experts interviewed are currently using AI and ML in their work, which has increased from 54% from the 2023 survey. Additionally, 62% of the survey respondents specified that their company will be investing in AI and ML tech over the course of the next two years (1).

However, 52% of the respondents to the survey cited “low quality and poorly curated datasets as the biggest barrier to AI implementation” (1). Concerns were also raised over data privacy and security issues, with 41% of respondents in 2024 citing this as a concern compared with 34% in 2023. Furthermore, over a third of the respondents (38%) specified concern that data will not be findable, accessible, interoperable, and reuseable (1).

“The good news is that cultural barriers to AI adoption are falling as organizations realize the benefits of the technology for accelerating scientific innovation,” said Becky Upton, president of the Pistoia Alliance, in a press release about the report (2). “But the survey shows a sizeable number of respondents are still facing data issues, and fresh concerns are arising around privacy and security, perhaps due to the ambiguities surrounding new legislation including the EU [European Union] AI Act.”

What Will the Labs of 2030 Look Like? A Global Survey May–August 2024.

Pistoia Alliance. Lab of the Future Survey 2024. Press Release, 25 Sep. 2024. 

Felicity Thomas is associate editorial director of 

When referring to this article, please cite it as Thomas, F. Barriers to AI Adoption. 

The use of artificial intelligence and machine learning has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.

Barriers to AI Adoption

Cell and Gene Therapy Production Facilities

Once a therapy has been discovered and proven, it has to be manufactured in order to reach patients. However, depending on the therapeutic modality, companies can be left with a difficult decision of whether or not their existing facilities will meet their manufacturing needs or whether they need a new facility entirely. Cell and gene therapies come with unique challenges that must be considered when either building a new manufacturing facility or expanding an existing one. Peter Walters, Fellow of Advanced Therapies at CRB Group, gives his insight on some of the challenges and benefits of creating new production facilities and/or expanding on what is already available.

To ensure one follows current good manufacturing practices when building a new facility for the production of cell and gene therapies, Walters stresses that one should understand the requirements by reading the European Medicines Agency (EMA) or the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines. “[T]hose, I think, are the most prescriptive in terms of what is expected and what is possible to do with your facility and your equipment, and the kinds of classifications [and] handling requirements required,” says Walters. “I think it's important to brush up on those, because cell therap[ies] especially have requirements that are a bit nuanced and different than a lot of other biotech—a lot going to chain of custody, a lot going to the degree of segregation that has to happen, the degree of quality control that has to happen, especially with open operations. A lot of these therapies can't be sterilized just prior to filling, and so they have to be handled with extreme care throughout the entire lifespan of their production, and so, … understanding those requirements is going to be crucial [to make] sure you've got a facility and an equipment plan and a development plan that's going to get you the whole way through to commercial.”

When it comes to using a current facility to expand a cell or gene therapy pipeline, Walters says, “I think we've seen a number of companies successfully, effectively, more or less bolt on a production facility onto their existing building, or build a small [campus], [such as] create a small building that has a spine that connects it, or something like that.

And so that way you're not really disrupting your ongoing production, but you gain the access to that office space. You gain access to the labs and the warehousing and all of that sort of shared, common support space that maybe can be leveraged across both [and] utility systems can sometimes be split between the two. [T]hat way, you can create a new production that doesn't have to come with the cost of a whole new mechanical infrastructure, and especially if we're talking about cell therapy, typically, those types of facilities have a larger air handling load sometimes, but they can be smaller clean rooms. And so, the overall load could be small, and then the rest of the utility load might be very, very low.”

Click the video above to watch Peter answer the following questions:

My company is planning new construction of a cell and gene therapy production facility. How can we ensure it meetings CGMP requirements?

How can we use our current facility to expand our cell and gene therapy pipeline?

Peter Walters is Fellow of Advanced Therapies at CRB Group.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.