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

Felicity Thomas

It’s the most wonderful time of the year … unless you are struggling to get a hold of prescription or even some day-to-day medicines as a result of drug shortages! Throughout Europe, there has been a rising shortage of a variety of medicines, including common antibiotics and painkillers, causing, and pardon the pun, headaches to not only patients, but also pharma companies, regulatory bodies, and governments.

From late 2022, numerous countries across Europe started reporting serious issues sourcing important drugs, leading to shortages in supplies. Most notably, supplies of the antibiotic amoxicillin were low along with children’s paracetamol and blood pressure medicine (1).

A survey of 29 European countries, conducted by the Pharmaceutical Group of the European Union (PGEU), revealed that, for most, medicines shortages had been worse in 2022 when compared with the prior year. The three most common causes of shortages were highlighted in the survey as “disruption or suspension of the manufacturing process”; “quota imposed by the manufacturer”; and “unexpected or high increase in demand” (2).

To try and prevent further shortages, the European Commission has adopted a new approach comprising a mechanism to share medicines across the bloc and emergency measures (3). In the United Kingdom, mandatory requirements for companies to monitor and report any potential discontinuations or supply issues with medicines were implemented in 2019 (4).

However, potential supply chain issues can only be mitigated to a certain degree as other, sometimes surprising, global disruptions occur. For example, the COVID-19 pandemic and the war in Ukraine both took supply chains by surprise; however, Brexit has and is continuing to cause difficulties in medicines supply, particularly for the UK.

As shortages of medicines have grown year-on-year since 2000 in Europe (5), it seems as though greater efforts to solve the problem are required.

1. Martuscelli, C. Europe is Running Out of Medicines. 

Medicine Shortages: PGEU Survey 2022 Results

. Survey Report, January 2023.
3. European Commission. 

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions Addressing Medicine Shortage in the EU

. Communication, 24 Oct. 2023.
4. Department of Health and Social Care. 

DHSC Reporting Requirements for Medicines Shortages and Discontinuations

. Guidance Document, 21 April 2021.
5. Louloudi, J.; Morfonios, N.; Zafeiropoulos, K. Why Europe is Chronically Running out of Meds. 

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

When referring to this article, please cite it as Thomas, F. Falling Short. 

Articles

Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.

Falling Short

Northway Group—a group of 17 enterprises within the fields of medicine, healthcare, biotechnical formation, and investment operations—has announced its latest project, in a Nov. 16, 2023 press release, that will see a vast biotech city be built in Vilnius, Lithuania.

The biotechnology hub, BIO CITY, will be the largest in Europe and home to an impressive six large biotechnological complexes—four of which will be state-of-the-art good manufacturing practice (GMP) plants and two of which will be scientific research centers. The whole site will be in an area equivalent to the size of 10 football fields and is expected to cost a total of €7 billion ($7.6 billion) over the course of a decade.

“We envision BIO CITY as a frontrunner in the European biotechnology, by uniquely integrating various biotech segments into a single, synergistic ecosystem,” said Prof. Vladas Algirdas Bumelis, founder and CEO of Northway Biotech and Celltechna, in the press release. “This multifunctional complex will catalyse interdisciplinary collaborations, the quick realisation of ideas and technological advancements. Our unique model, which brings together diverse biotechnology fields in one location, is set to revolutionise the European biotech landscape.”

A gene therapy center will be the first facility to open in the BIO CITY in 2024. Currently under construction by Northway Group’s subsidiary, Celltechna, the center will specialize in gene therapy research and GMP manufacturing and will span 8000 m2. Additionally, the center is expected to create more than 100 high-value jobs for the region.

“Our state-of-the-art [gene therapy] facility will be instrumental in both research and production, offering new treatments for previously incurable diseases. This will not only augment our CDMO [Contract Development and Manufacturing Organisation] capabilities, but also position us for global competition and collaborations,” added Bumelis.

“A science-based economy, supported by bright minds and intelligent entrepreneurs, is the foundation for Lithuania’s long-term economic prosperity. In the past, our growth was constrained by a lack of fossil resources, but today, we are boldly moving forward, relying on modern technologies,” said the president of the Republic of Lithuania, Gitanas Nausėda, in the press release. “The new biotechnology hub embodies the direction of Lithuania’s innovative economy. It also promises new inventions that will enable people with serious illnesses to become full members of society, thereby reducing exclusion.”

The largest biotech hub is set to be built in Lithuania by Northway Group.

Lithuania Set to Become Home to Largest Biotech City

Specialist integrated contract development and manufacturing organization (CDMO), Hovione, has acquired ExtremoChem, which is a start-up company with a portfolio of rare sugars, expanding its technology platforms.

According to a Nov. 16, 2023 press release, the acquisition gives Hovione access to ExtremoChem’s portfolio of rare sugars. These high-performance functional materials are synthetic analogues of the natural molecules found in extremophiles–organisms that can survive in uninhabitable environments—and have shown the potential to stabilize biopharmaceuticals during production, purification, formulation, and transportation.

“Proteins and other biopharmaceuticals account for a significant share of our customers’ pipelines,” said Dr. Jean-Luc Herbeaux, CEO, Hovione, in the press release. “The acquisition of ExtremoChem’s synthetic sugars combined with Hovione's particle engineering capabilities provides our customers with a unique set of tools to optimize formulations that address stability issues encountered during the life cycle of biopharmaceuticals.”

“I am delighted that ExtremoChem has been acquired by Hovione,” added Filipe Aguiar, managing director, ExtremoChem, in the press release. “Hovione has a long history of developing and industrializing innovative technologies for the pharma industry. This acquisition will help ensure that the science we developed at ExtremoChem will have a wider and faster market adoption.”

This latest news from Hovione further bolsters the company’s position in seeking to expand its technology platforms, which it reports is needed to meet customer demand for integrated and differentiated development and manufacturing services. The acquisition of ExtremoChem adds to new partnerships forged by Hovione, such as that with 

 for the advancement of a dry powder inhaler platform and with 

 to expand the use of the Epidel platform beyond ophthalmic applications.

Hovione has acquired start-up company, ExtremoChem, expanding its technology platforms.

Hovione Expands Technology Platforms with ExtremoChem Acquisition

The United Kingdom’s industry body, the Association of the British Pharmaceutical Industry (ABPI), has reacted positively to the Autumn Statement from the government’s Chancellor, Jeremy Hunt.

In his Autumn Statement, Hunt outlined the government’s plans to foster growth within the UK, including “dynamic and innovative” investment into the life sciences. The plans encompass, among other things, investments of more than £750 million ($936 million) to go towards UK R&D, £20 million ($25 million) for a new cross-disciplinary proof-of-concept research funding scheme, and £520 million ($649 million) to strengthen manufacturing resilience for potential future health emergencies.

Responding to the Autumn Statement, Richard Torbett, the chief executive of the ABPI, said in a Nov. 22, 2023 press release, “The Chancellor has recognized the high potential of UK life sciences to deliver the jobs and growth the country needs. This package of support will help boost our sector's investment in UK-based research and manufacturing.

“The £520million funding boost for manufacturing is a major step forward in delivering on our shared ambitions for long-term growth. Also welcome is the plan for a new merged R&D tax credit scheme and the move to make permanent the full expensing capital allowances model. Together, these steps will help give confidence to companies looking to make larger, long-term investments into the UK.

“Set alongside commitments in the new Voluntary Scheme agreement to improve the ecosystem for innovative medicines, as well as progress to address challenges in industry clinical trials, the UK is getting back on track to realise the Prime Minister's vision of being a life sciences superpower.”

UK industry body, ABPI, has responded positively to the recent Autumn Statement.

Industry Responds to the UK’s Autumn Statement

The Shape of Things to Come: Advances and Improvements in Excipients

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, 

Group, interviews experts innovations in oral and topical drug delivery. During the video, Ashley Rezak and Nick DiFranco from Lubrizol Life Science Health look at the overarching oral and topical drug delivery trends and how these are impacting excipient innovation in particular. Mucoadhesion and solubility/bioavailability enhancement are particularly focused upon during the chat, with Ashley and Nick wrapping up the conversation about hindrances to the excipient sector and ways that recent developments, such as CDER’s pilot review program, are helping industry to overcome these difficulties.

Nick DiFranco, MEM, Global Market Segment Manager for Oral Drug Delivery at Lubrizol Life Science Health

Nick DiFranco, MEM, is the Global Market Segment Manager for Oral Drug Delivery at Lubrizol Life Science Health. In his role, Nick coordinates a multi-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and liquids, including Carbopol and Apinovex polymers. Prior to this role, Nick held positions as an Applications Scientist and Market Manager at Lubrizol supporting long-acting drug delivery and CDMO services. Nick holds a BS in Biomedical Engineering (Biomaterials focus) and a Master of Engineering and Management degree from Case Western Reserve University.

Ashley Rezak, Global Market Manager—Topical Drug Delivery for the Pharmaceutical Excipients division at Lubrizol Life Science Health

Ashley Rezak currently serves as the Global Market Manager—Topical Drug Delivery for the Pharmaceutical Excipients division of Lubrizol Life Science Health. She obtained her BSE in Biomedical Engineering, with a minor in Polymer Engineering, from Case Western Reserve University. Ashley joined Lubrizol in 2018 and has held several roles with the company since then. She is currently responsible for marketing, business development, and strategy efforts pertaining to topical pharmaceutical ingredients.

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.

Solid Dosage Drug Development and Manufacturing

 APIs, Excipients, and Formulation Advances

Videos

In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, chats about the biggest trends impacting oral and topical drug delivery and how these trends are impacting the excipient sector with Nick DiFranco and Ashley Rezak from Lubrizol Life Science Health.

Drug Digest: The Shape of Things to Come: Advances and Improvements in Excipients

Poorly aqueous soluble compounds account for a major proportion of the drug development pipeline and, if not correctly formulated, can end in costly failure for companies. To overcome the obstacle of poor aqueous solubility in drug development, companies can choose from a number of different approaches, such as particle size reduction, salt formation, using a surfactant, and so on.

University of Copenhagen spin-out company, Zerion Pharma, has developed a new technology, Dispersome, to help solve drug solubility issues. To learn more about the company and its new formulation platform, 

 spoke with the company’s chief executive officer, Ole Wiborg, at CPHI Barcelona 2023.

“We have developed a new technology platform that can be used to [increase the] solubility of small-molecule drugs,” specified Wiborg. “Generally, our technology works for most small-molecule drugs, even for some of the molecules that are characterized as ‘brick dust’—which means almost like sand and so you cannot make them into solution.”

Additionally, Wiborg revealed that the technology is finding use within the cannabis field—an area where there are some very difficult molecules to work with. “So, in general, I would say that [our technology] is applicable across a broad area … and works for up to 80% to 90% of molecules,” he stated.

Experimental work on the company’s platform has also been published in peer-reviewed journals, Wiborg pointed out. For example, in June 2023, Zerion Pharma announced that work from two partnership projects had been published in both the 

International Journal of Pharmaceuticals 

, which demonstrated the relationship between drug loading and dissolution of Dispersome formulations of Nimodipine (1).

“We are now anticipated at the beginning of next year [2024] we will have two clinical studies with our partners that are in the cannabis field,” Wiborg remarked. “So, we will soon have a lot of human data to support the technology.”

1. Zerion Pharma. Zerion Pharma’s Dispersome Technology Published in Two Peer-Reviewed Papers Through Partnerships with Pharmaceutical Companies. 

Zerion Pharma was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Ole Wiborg from Zerion Pharma, a Danish pharmaceutical development company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.