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

Felicity Thomas

Since 2020 and the United Kingdom’s exit from the European Union, Britain has been locked out of the Horizon research programme, despite agreements being in place for associate membership, as arguments over the Northern Ireland protocol persisted. However, in March 2023, after the implementation of the Windsor framework, talks between the UK and EU about the association with the programme resumed, culminating in reports of a draft deal being reached on 5 July (1).

This draft deal is reportedly now under consideration by the UK’s Prime Minister, Rishi Sunak (1). Sunak is being urged to finalise the deal to ensure the scientific community in the UK can regain the advantages of the Horizon programme, such as funding and leading multi-country research consortia.

“Outside Horizon Europe, the UK is in real danger of ceding our hard-won position in the global R&D hierarchy and becoming less attractive as a research partner and less attractive for foreign direct investment,” stressed Andy Slaughter, member of parliament for Hammersmith in a parliamentary debate on the topic of Horizon Europe (2). “As part of Horizon Europe, the UK can influence the future direction of billions of pounds worth of research investment to more closely align with UK strategic priorities.”

Cost has been a factor delaying the draft deal. Although not required to pay participation fees for the two missed years, the UK government has requested further discounts due to the fact that researchers and businesses in the country have been weakened when compared with EU counterparts from missing out on collaborative opportunities. Additionally, the UK government have pushed back on the matter of how much research funding the country will receive in return for its input into the programme (3).

Officially, talks are still ongoing with no confirmed deal struck yet—at the time of writing—so, for now, a return to a closer scientific research relationship between the UK and the EU remains just out of reach on the horizon.

1. Gallardo, C. Britain and EU Agree Draft Horizon Deal. 

, 5 July 2023.
2. UK Parliament. Research and Development Funding and Horizon Europe. Parliamentary Debate, 18 April 2023.
3. Ghosh, P. Horizon Research Deal with EU Awaits Sunak’s Signature. 

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as Thomas, F. The Swiss Appeal. 

Articles

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

New Deal on the Horizon

Contract development and manufacturing organization (CDMO) Aenova has opened a new building for the production of highly potent APIs at its Regensburg site in Germany, it was announced in a June 23, 2023 press release.

With this investment, worth a total of €25 million, Aenova will be able to increase its development and production capacities for cytotoxics and cytostatics and meet the growing market demand for these ingredients. The new building comprises four stories with a total building area of more than 4000 m

 and includes production and packaging facilities for highly potent tablets along with associated laboratories, development, storage, and social rooms.

“Producing billions of tablets and capsules each year, Aenova is a partner of choice for novel product solutions as well as commercial high-volume manufacturing,” said Oliver Schmied, managing director at the Aenova site in Regensburg, in the press release. “A particularly unique selling point is that we offer production flexibility using harmonized production equipment, enabling small to large batches from 0.5 to 500 kg for development, [clinical trial materials], scale up, and commercial batches.”

“Within the overall investments of the Aenova Group, the new building for highly potent APIs in Regensburg is an essential strategic building block,” added Jan Kengelbach, CEO of the Aenova Group, in the press release. “As a development and manufacturing partner, we are thus a reliable and agile CDMO for our customers in the promising market segment of highly potent active ingredients.”

Aenova has opened a new building for the production of highly potent APIs in Germany.

Aenova Opens New Building for Highly Potent Drugs

By the end of 2022, biologic-based drug approvals accounted for a slightly larger proportion of approvals than the number of small-molecule new molecular entity approvals (1). With this shift in focus for the industry toward more complex molecules that are prone to degradation comes an increased need for more careful manufacturing processes that can ensure contamination-free end products are made.

Largely driven by this exponential increase in demand for biopharmaceuticals, the aseptic pharmaceutical processing market is estimated to grow at a compound annual rate of 7.9% between 2021 and 2031 (2). “During the past few years, sterile drug development and production has grown significantly as a consequence of the type of products that are coming to the market—biological drugs, advanced therapies, and so forth,” concurs Rafael Beaus, global consultancy manager, Telstar.

For David Stevens, global chief commercial officer, Kindeva Drug Delivery, a combination of factors is impacting aseptic and sterile drug manufacturing. In response to the increased focus on more challenging molecules, innovators have been using more advanced formulation strategies, he explains.

“Additionally, the need to optimize production costs of medicine, including even the most innovative biologics, has been further heightened by recent global inflation, which has ratcheted up pressure on the pricing power of pharmaceutical marketers already being challenged by government downward pressure on drug reimbursement costs,” Stevens continues. “Even in the [United States], historically, the most amenable to pharma drug pricing—payors—have consolidated their buying power, and pharmaceutical companies and healthcare industry-wide are having to adjust to the reality of a more cost-conscious environment.”

As a result, Stevens notes, growth in more specialized, targeted, and precision treatments is being seen, as these types of therapies can provide options for previously untreatable conditions or offer payors more sustainable value for their therapeutic costs. “The implication for sterile drug product manufacturers is a growing shift toward products that require meaningfully smaller production batch sizes and more complex manufacturing processes,” he says.

In addition, the recent COVID-19 pandemic has hastened the uptake of patient self-management, leading innovators toward development of novel products that differentiate them from their competitors and allow patients to administer therapies at home with the same level of safety as in the clinical setting, Stevens remarks. “This [trend] has propelled growing interest and demand for pre-filled syringes and autoinjectors, which provide patients with the convenience and simplicity of user-friendly devices with pre-defined volumes and efficient low-waste doses outside of a clinical setting, which in turn offers reduced cost and differentiating proof points for patients and payors,” he states.

Looking at technology, Joerg Zimmermann, vice president Vetter Development Service, External Affairs, reveals that there is a clear trend toward more automation and the introduction of robots in aseptic manufacturing, along with digitalization of all processes via the Internet-of-Things or Pharma 4.0. “All this [change] is leading to even more robust and safe processes for manufacturing sterile drug products,” he says.

Keeping people, who are the main contamination source in aseptic manufacturing, out of the critical areas where a product is exposed is becoming a more pressing concern for industry, stresses Beaus. “This [demand] means that automation is being required more in aseptic processes, as well as the use of closed systems and engineering solutions to provide maximum safety to products,” he adds.

“Obviously within GMP [good manufacturing practice], there is a continuous pursuit of greater levels of patient safety, which, for injectable medicine, translates to pursuing even greater levels of sterility assurance that naturally leads to engineering innovations to minimize direct human intervention in the production process,” specifies Stevens. “Most notably, however, the EU [European Union] GMP Annex 1: Manufacture of Sterile Medicinal Products update, published in August 2022, clarified expectations for sterile products that reinforced contamination control requirements and emphasized the role of engineering out associated risks using technology where possible” (3).

The issuance of the revised Annex 1 guidance came after two long commenting phases and will be largely coming into effect in August 2023, Zimmermann reveals. “While some say that it is nothing new in terms of content, the regulation has become much more prescriptive, and this is currently raising the question of what the right interpretation is,” he says. “As Annex 1 is not only published by the EU, but also adapted almost identically by WHO [World Health Organization] and PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme], this will be the global standard going forward.”

Interpreting the revised Annex 1 guidance document will prove to be the biggest challenge for companies dealing with aseptic manufacturing in the near future, Zimmermann stresses. “While the consultations between regulators and members of the industry were successful on several issues, some paragraphs can be misunderstood. It is therefore of the utmost importance to understand the intent, and this is being worked on in conferences, seminars, and symposiums,” he states.

Beaus adds that, in light of the revised guidance, companies will need to improve their know-how of new facility design to ensure they are fully compliant moving forward. Furthermore, challenges will arise when existing facilities are upgraded to meet the new regulatory expectations while also maintaining sufficient production, he emphasizes.

“With greater regulatory compliance demands, including the wide-ranging aseptic processing and contamination control strategy implications of updated GMP Annex 1 guidance, pressure on older facilities with older lines will be appreciably felt, accelerating a shake-up of market players that is likely to increase pressure on already limited high-quality capacity,” agrees Stevens. In anticipation of the impact these regulatory changes will bring, pharma innovators have already started to demand the use of best-in-class fill/finish technology within internal and external manufacturing supply chains, particularly for innovative pipeline products, he confirms.

Another obstacle that has impeded the industry over the past few years, particularly during the pandemic, has been shortages of certain materials, such as single-use systems, bags, filters, and so forth, in the supply chain, notes Zimmermann. Although, this issue has mostly been resolved now, he states.

The shortage of gamma-sterilization capacity has also caused some difficulties, Zimmermann continues. “The combination of higher demand and the scarcity of cobalt-60 have led to a fundamental rethinking of the choice of sterilization methods. Alternatives are being introduced, with X-ray sterilization becoming a popular choice,” he says.

“While a lot of large-scale capacity was brought quickly into the market during the pandemic, there is a lack of capacity for smaller, more specialized products, particularly when looking at the rise of mRNA [messenger RNA] therapeutics and other newer modalities,” confirms Stevens.

Newer modalities, such as advanced therapeutic medicinal products (ATMPs), which include cell and gene therapies, pose unique challenges for manufacturers, Zimmermann points out. “Many [ATMPs] are autologous, meaning that patient-derived cells are being modified and reapplied to the patient. This is the so-called batch-size 1, and the processes are more comparable to microbiological lab processes than industrial processes,” he says.

“Finally, acute downward pressure on generic injectable medicines, as reflected in the drug shortage list, has created an imperative toward improving manufacturing efficiency, further amplifying the need to adopt high-throughput, faster lines that take advantage of automation and isolator technology,” Stevens emphasizes.

For new facilities, more importance is being placed on isolators and automatic processes, with many manual operations being replaced, Beaus remarks. “All-in-all, new facilities are being designed to allow visitors to view the main operations from the outside,” he says.

In the case of existing facilities, however, companies need to upgrade the existing equipment, revamp areas, and implement automated solutions to continue production that complies with new requirements, Beaus adds. “There’s room for increasing the automation level in existing facilities to be able to skip most of the current manual operations. The balance between investment needed and product safety is what is difficult, as automation is quite expensive, making it difficult to justify the return on investment,” he states.

As an example, Stevens highlights Kindeva Drug Delivery’s newly constructed aseptic manufacturing facility in Bridgeton, Mo., where the company has adopted isolator technology as standard to offer optimum aseptic operating principles for the manufacture of sterile injectables. “Single-use technology has also been a game-changer for multiuse/multi-product facilities in terms of room turnaround and the elimination of reliance on cleaning methods, assuring there is no carryover from product contact surfaces,” he specifies.

“There is a trend to move toward more automation of aseptic processes,” concurs Zimmermann. “Transfers between processing steps can be realized with robots or automatic transfer systems, and there is a clear recommendation in Annex 1 to automate the loading and unloading of lyophilizers.”

Decontamination of cleanrooms is another area where automated solutions are providing benefits, Zimmermann remarks. Using Vetter as an example, he highlights the Vetter Cleanroom Technology, V-CRT, which is a fully automated system designed to fully decontaminate conventional restricted access barrier systems grade A/B rooms, allowing for optimized contamination control in critical zones.

“While gloveless isolators were first introduced a decade ago, there are further developments being done to optimize the systems with even more automation, including robotized microbiological environmental monitoring and avoiding contact of H

 [hydrogen peroxide] with the packaging components,” Zimmermann continues.

In the future, manufacturers will face hurdles as a result of the growing number of small-batch targeted biologics entering the pipeline because most commercial capacity has been designed for larger, recurring volumes, Stevens specifies. “Additionally, the complex and expensive drug substance production processes required for high-value biologics, such as mRNA and viral vectors, will further drive the goals of maximizing sterility assurance to minimize risk of batch failures,” he says.

Although in agreement that personalized medicines, developed in small facilities close to or even inside hospitals, with significantly high-value products will be a certain trend requiring flexible facilities, Beaus also believes development will occur for more common products too. “There will be [highly] efficient specialized facilities, that are [significantly] automated, where most common aseptic and sterile products are produced as commodities, with maximum safety for product, but at the same time achieving low cost per every produced unit,” he says. “This trend may be applicable to vaccines, large volume parenterals, or some other general sterile products.”

“Further trends are definitely in the artificial intelligence space, particularly regarding automated visual inspection,” Zimmermann states. Currently, the naked eye remains a reference point within this area of the process, so digital camera systems will offer huge assets in the future, he notes.

“Manufacturers face the challenge of being flexible to stay in touch with evolving requirements for new drug-delivery approaches, be that in more complex formulations or in administration methods,” Stevens concludes. “For manufacturers, the task is figuring out how flexible they need to be to meet this trend.”

1. Senior, M. Fresh from the Biotech Pipeline: Fewer Approvals, but Biologics Gain Share. 

, 41 (2), 174–182.
2. Research and Markets. 

Aseptic Pharma Processing Market—Global and Regional Analysis: Focus on Product, Technology, Regional, and Country Analysis—Analysis and Forecast, 2021–2031

Volume 4, Guideline, Final Version, Aug. 22, 2022.

When referring to this article, please cite it as Thomas, F. Facing the Future of Aseptic Manufacturing. 

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

Facing the Future of Aseptic Manufacturing

With the COVID-19 pandemic in the world’s ‘rear-view mirror’ to some degree, the future for the bio/pharma industry is expected to bring a plethora of opportunities. However, along for the ride with these opportunities, there will also be a unique set of challenges to overcome to ensure prospects are taken advantage of successfully.

Over the past few years, the bio/pharma industry has been experiencing a shift in focus. Of particular note are the increasing numbers of complex and biological therapies entering the development pipeline. These novel therapeutics can prove to be difficult to handle from formulation to manufacture and further along the supply chain.

https://europe.cphi.com/europe/en/exhibit/exhibit/why-exhibit.html

https://europe.cphi.com/europe/en/attend/attend/why-attend.html

https://europe.cphi.com/europe/en/attend/attend/tickets.html

Note, there is a range of ticket options available at varying costs. Discounted rates are currently available but will end on 3 September 2023.

The topic of novel therapies will be well covered in CPHI’s 2023 conference agenda, featuring a number of tracks aimed at assisting with the potential challenges the near future may hold (see ‘Future‑focused agenda’ for a full outline of the topics to be covered during the in-person event).

From 11:15 am on day one of the event (24 Oct. 2023), Lonza Capsules and Health Ingredients will be presenting on future formulation challenges in “Emerging Drug Delivery Technologies for Novel Formulations.” In this 20-minute session, the characteristics of developed products will be reviewed so that the required tools for drug delivery can be determined, and alternative delivery routes will be evaluated.

On the second day of the conference (25 Oct. 2023), Moderna is set to delve into potential applications of messenger RNA (mRNA). The session, “From COVID to Oncology—What’s Next for mRNA Applications?,” will run from 11:40 am for 20 minutes and will look at lessons learned from the mRNA COVID-19 vaccine and the role of nanoparticles in vaccine efficiency.

Technological innovations have been filtering into the bio/pharma supply chain for a while, albeit at a slower pace than other industries have experienced. In a panel session, “Generating the Potential of Artificial Intelligence for Pharma Manufacturing,” held from 12:55 pm on the second day of the conference, experts will give their thoughts on how artificial intelligence can help to improve batch manufacturing, quality and regulatory compliance, and patient engagement. The panel will also assess the role of chatbots and where training can be improved within the manufacturing sector.

A new addition to the 2023 event will be the Start-Up Market, taking place across the whole three days of the event (24–26 Oct. 2023). The Start-Up Market will be located in Hall 3 of the conference centre and will provide a space for start-ups, innovators, and small enterprises to connect and exhibit their new products and solutions.

A main element of change for CPHI each year is that of the conference agenda. For the 2023 event, key topics set to impact the industry over the coming years will be broached thanks to a host of thought leaders and experts of relevant fields.

An outline of the topics to be covered on-site at CPHI in Barcelona is as follows:

—this track will investigate the innovations helping to shape the biomanufacturing landscape.

—for this theme, sponsored by Lonza Capsules and Health Ingredients, relevant experts will tackle the challenges facing formulators when dealing with therapies of the future.

—in this section of the agenda, attendees will be able to learn about the intricacies of partnerships.

—for this SUDPACK Medica-sponsored track, experts will provide practical tips on ways to be sustainable.

will highlight more personalized, precision, and novel therapies.

—the ability of digitalization to improve efficiencies, both in terms of cost and output, will be examined in this track, sponsored by Procaps.

—patients take centre stage for this Gerresheimer-sponsored section of the conference, with experts talking about ways to improve the patient experience across the board.

—the US Pharmacopeial Convention sponsors this track, which will focus on tools that can improve quality management throughout the supply chain.

For the latest updates on the conference agenda visit 

With high inflation also comes budgetary pressures. One way to alleviate the financial burden and improve the all-important return on investment is to accelerate molecules through the development pipeline to commercialization.

Tackling this very topic on the first day of the conference at 11:40 am will be Magnus Blomberg from AstraZeneca. In a 20-minute slot titled ’Speed to Market’—Pipeline Acceleration Strategies for Biologics Manufacturing, Blomberg will provide insights into strategies that can speed up biologics manufacturing and hence drive efficiencies.

Another tool that can drive efficiencies when implemented correctly is the use of a suitable contract development and manufacturing organization (CDMO). Towards the end of the first day at 3:55 pm, Federica Fraschetti from Merck, Julien Laizé from Valneva, and Shilpi Ghosh from Roche, will all sit on a panel for “The CDMO Outlook,” where they will cover ways to determine what services a sponsor company may require, whether it is more economically beneficial to perform tasks in-house, ways to optimize communication with a partner company, and the times when outsourcing should be avoided.

Sustainability is becoming an ever‑important aspect impacting day‑to-day life. The bio/pharma industry is not excluded from this shift, with expectations for more sustainable practices to be implemented throughout the life cycle of drug products.

During the Formulating the Future track on day one of the conference, Juan Colberg from Pfizer will detail ways in which companies can make their businesses greener. In “Green Chemistry Initiatives in APIs” at 12:05 pm, Colberg will broach greener alternatives for API production, investing in sustainability as a long‑term growth opportunity, and ways to incorporate sustainability into the production lifecycle.

After lunch on day one at 15:05 pm, Berta Mota from Anthesis Group will give an overview of the financial benefits that can be gained with a strong environmental, social, and governance (ESG) strategy. “Driving Profitability Through a Solid ESG Strategy” will cover topics such as how open transparency can aid in the identification of appropriate investors and lessons for pharma to learn from non-governmental organization green action schemes.

There will be many more sessions to enjoy while attending the event in person than those listed here. For up-to-date information on the conference agenda, visit the event website at 

Furthermore, for the duration of the in-person CPHI event, the Fira Barcelona centre will also be home to a vast number of exhibitors, located across eight halls. If you would like to visit the Pharmaceutical Technology® Group team while attending the show, you can find us in Hall 3 Booth Q74.

If you have never visited Barcelona before, or even if you visit the city regularly, take a look at our brief list of some key tourist hotspots to view when you are there for CPHI in October 2023. The article can be viewed by clicking 

When referring to this article, please cite it as Thomas, F. Planning the Future of Pharma at CPHI. 

The future is set to be a running theme for this year’s CPHI event, which will take place in-person at the Fira Barcelona Gran Via in Spain between 24–26 October 2023.

Planning the Future of Pharma at CPHI

Small in size but not in impact, landlocked Switzerland is widely considered a pharmaceutical powerhouse of Europe and is the birthplace to two industry giants, Novartis and Roche, and home to numerous other firms of varying sizes. Further cementing the country’s reputation as a prime location for industry, research conducted by IQVIA, published in Swiss Biotech Report 2023, has shown that Switzerland is attracting global biotech attention (1).

The research findings demonstrated that a fifth of European biotech companies now have their headquarters in Switzerland and international companies are increasingly looking to Swiss locations for their international hub. This popularity is thanks in part to the country’s ecosystem, which is built around several biotech hubs located in specific regions—Basel, Zurich‑Zug-Lucerne-Schaffhausen, and Romandie (1).

“We’ve seen a continued growing interest from biotech companies in our ecosystem, especially in the last decade. In view of the geopolitical shifts, Switzerland’s stability is a major advantage,” said Patrik Wermelinger, chief investment promotion officer, Switzerland Global Enterprise, in a press release about the research (2).

Additionally, the country’s high rate of approvals granted by Swissmedic is another advantageous aspect of setting up shop in Switzerland for biotech companies. “Swissmedic strengthens the Swiss research hub by supporting innovation and accelerating the approval process for new drugs long before they are ready to be commercialized,” added Jörg Schläpfer, head of Management Services and International Affairs at Swissmedic, in a press release (2).

Another string to the Swiss bio/pharma bow is the country’s access to talent and ability to retain said talent (3). The country has done well in the Global Talent Competitiveness Index, actually ranking top since the launch of the index in 2013 and is described as a global leader in enabling and retaining talent within the report (4).

Finally, Switzerland’s approach to drug exclusivity is a major bonus, particularly for innovators as they can gain 20 years of exclusivity (5), which is much longer than in the United States or across the European Union. Throw in some other benefits, such as favourable taxation, strong investment into research, and a high quality of life, and a move to within Swiss borders seems to be a ‘no-brainer’ for biotechs everywhere.

. Market Research Report, April 2023.
2. Switzerland Global Enterprise. Latest Research Shows 20% of European Biotechs Now Headquartered in Switzerland. News Release, 24 May 2023.
3. Haywood, A. Why Are There So Many Pharmaceutical Companies in Switzerland? 

, 10 Aug. 2020.
4. Lanvin, B.; Monteiro, F. 

, November 2022.
5. Davis Plüss, J. New European Pharmaceutical Rules Met with Scepticism in Switzerland. 

Despite being a relatively small nation, Switzerland is booming for biotech innovation.

The Swiss Appeal

Barcelona is a renowned hub where culture and history blend with the vibrant locale. Situated in the Catalonia region of Spain, the city offers a plethora of options to tourists to tantalize all the senses. Below is a brief list of some of the biggest hotspots to try while visiting:

—this is probably the most iconic and well recognized landmark from Barcelona, the Antoni Gaudi designed church. Construction, although started in 1882, is still ongoing but do not expect a building site when visiting. The grand facades are beautifully ornate and awe inspiring, and if you feel brave enough you can even gain an elevated view of the city scape by venturing upwards in the church spires.


—more of Gaudi’s intriguing designs can be enjoyed at this public park. Located at the top of a hill, visitors can enjoy panoramic views of the Barcelona cityscape while sitting on mosaic imbued benches.


 Between September and March, daily from 8.30 am

—Picasso lived in Barcelona for around a decade of his life and within this dedicated museum you will find thousands of his original works. Set out in a chronological order, the pieces of art demonstrate the evolution of Picasso’s style right up to the iconic cubist paintings for which he became most famous.


—if football/soccer is more your style, then a visit to the city’s ‘super club’ stadium is a must. The 100,000-capacity venue can be enjoyed on match days, when the atmosphere will be palpable, or it can be toured when there are no matches happening, with even the possibility of a look at the trophy room.


—the 1.2 km stretch of pedestrianized street is a hive of activity and sensory delights. Numerous restaurants, cafés, and shops line the boulevard with artists and performers dotted long the way, allowing for regular entertainment pit stops. Be careful while enjoying the various distractions this tourist hot spot can offer however, as it is notorious for pickpocketing.

Here is a small selection of some of the inspiring places to visit while in Barcelona, Spain.