Press Room

Article / Sep 27, 2021

How the drug services industry found itself prepared for a pandemic

C&EN, 26 September 2021

CDMO drug substance analytical chemistry RD scientists | Hovione

Supply chain discipline has paid off for contract development and manufacturing organizations amid an ongoing crisis

by Rick Mullin

 

The time to repair the roof is when the sun is shining,” said President John F. Kennedy in his 1962 State of the Union address. The metaphor rang true during the Cold War as an admonition to guard against complacency in times of prosperity. More broadly, it registered as the kind of sensible advice that people during all times frequently ignore.

At its outset, COVID-19 proved a case in point, as a containable outbreak spread relentlessly despite years of warning from public health authorities of an imminent pandemic. Yet the crisis also went on to showcase instances of preparedness, foremost of which was the rapid development and deployment of effective vaccines. The pharmaceutical industry emerged as a hero of the pandemic.

Less obvious but just as important was the rapid response of the pharmaceutical services industry, which does much of the heavy lifting for drug companies, working behind the scenes to coordinate the shipment of raw materials, produce active pharmaceutical ingredients (APIs), and formulate finished products within a complex international supply chain.

The sector had been on a 10-year profitability streak before 2020 and has done even better during the pandemic. It navigated challenges posed by COVID-19 on the strength of previous improvements to supply chain management and a yearslong campaign of diversifying services and expanding manufacturing capacity. Those proactive measures put the industry in a strong position when the storm hit early last year.

Indeed, industry watchers say the drug services sector displayed enviable resilience over the past 18 months. “There were issues—I don’t think there were any questions about that. But I think we knew how to deal with it,” says James Bruno, president of the consulting firm Chemical and Pharmaceutical Solutions.

Unforeseen transportation holdups caused problems early on, as did rattled production schedules when companies found they suddenly needed to produce large volumes of APIs such as remdesivir and dexamethasone on a very short timeline. But companies were able to work out the supply chain snags, Bruno says.

 

Related: European Consortium Seeks Autism Drugs

Roger Laforce, an industry consultant based in Switzerland, notes that as vaccines advanced toward emergency approval last year, several service companies, often called contract development and manufacturing organizations (CDMOs), were in a position to make vaccines happen. The big Swiss firm Lonza, for example, relied on a 2018 investment in prebuilt manufacturing shells at its facility in Visp, Switzerland, to meet a tight deadline for bringing production of the active messenger RNA ingredient in Moderna’s vaccine on line.

“People who’ve invested in operational excellence—having good supply chain operations and good management practices around their inventory—have actually been able to do pretty well,” says Wayne Weiner, who heads the consulting firm PharmaTech Solutions. “The other thing CDMOs have done a good job at is managing protection for their workers—keeping them safe so they could actually come in and run the plants.”

The pandemic also served to illustrate a dilemma that CDMOs have been bringing to the attention of governments in the US and Europe to little avail—heavy dependence on China for antibiotics and other generic drugs. The global drug supply chain emerged as front-page news when the Donald J. Trump administration considered a “buy American” executive order for pharmaceuticals, and the US government allocated funds to support domestic production of critical drugs. The European Commission also turned its attention to domesticating drug supply. And even as the Joe Biden administration attempts to undo much of the legacy of the Trump administration, the focus on the drug supply chain remains.

 

ABSORBING THE SHOCK

“The CDMO is the shock absorber for the pharmaceutical industry,” says Guy Villax, CEO of Hovione, a Portuguese CDMO with facilities also in China, the US, and Ireland. “Whenever there is a problem, they ask us to fix it.” When an unforeseen requirement for large-scale vaccine manufacturing emerged last year, for example, “the CDMOs got their act together,” Villax says.

And they did so under duress. Villax says that 150 workers at Hovione facilities have tested positive for COVID-19 since the pandemic began. “Every single person has recovered,” he says. There were transportation snags, especially in China, when the pandemic hit, but those were sorted out before long.

And business is “very good,” Villax says. “I remember in April and May of last year, I had a torrent of calls from journalists really keen that I could give them evidence so they could write stories to show that the supply chain was a catastrophe and all the pharmacies would be empty in a short time,” he says. “In fact, none of that happened. I think the supply chain is somehow really resilient.”

One reason for the industry’s preparedness was its ongoing investment in new production capacity well before the pandemic hit. Hovione came into 2020 with a new research center in Lisbon, Portugal, and plans to open a manufacturing building in Loures, Portugal, with new reactor capacity, Villax says. And the firm plans further capacity increases.

The Swiss CDMO Siegfried is among the firms that landed contracts serving vaccine makers. Marianne Späne, chief business officer, says Siegfried had to build a new production line from scratch at its site in Hameln, Germany, to fill and finish vials of Pfizer and BioNTech’s vaccine.

While the company had fill-and-finish capacity, “we had never done vaccines, and in record time we were able to build it up, to validate the process,” she says. Bringing production on line was a matter of close collaboration with Pfizer and BioNTech, Späne says, adding that Siegfried also has a contract to provide Novavax with fill-and-finish services for the vaccine it is developing.

And as it did before the pandemic, Späne says, Siegfried is continually expanding capacity for small-molecule drug manufacturing at all its sites—in Switzerland, Germany, France, Spain, the US, and China—often by debottlenecking or streamlining processes to increase output.

The CDMO is the shock absorber for the pharmaceutical industry. Whenever there is a problem, they ask us to fix it. - Guy Villax, CEO, Hovione

 

Read full article at C&EN.org

 

 

Also in the Press Room

See All

Lisbon, May 21, 2024 – Hovione has placed fourth among the best companies to work in Portugal and was again the best in the Health Sector according to Randstad´s Employer Brand Research. The research, which was published yesterday, identified the 20 best employers in Portugal. This is the ninth annual edition of Ranstad´s study, which is based on a representative sample of the Portuguese workforce. The respondents evaluate companies according to a range of different criteria, including salary and benefits, job security, work atmosphere, and career progression opportunities. Employer branding can have a significant impact on an organization's ability to attract and retain top talent and so is becoming an increasingly important part of a company a strategy to address the talent shortage challenge.  Ilda Ventura, VP of Human Resources at Hovione explains that “Our global HR strategy is built on the need to attract, retain and empower our talented team members. Therefore, our Employer Branding needs to reflect the reality of who we are, so that we don’t just attract new talent but allow current team members to flourish. It also needs to capture the positive impact that Hovione has on the world, and how our innovative work relies on the knowledge and problem solving of our team members. We continue to work on refining and improving the work we do on our EB. This too is an important reflection of our values, and our belief in continuous improvement.” This is the third successive year that has been ranked as the most attractive company to work for in the Health Sector and placed in the top five overall  This recognition comes after Hovione was recognized as a Top Employer in all four of its global sites in January 2024, becoming the first company in Macau to do so.    About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.  

News

Hovione again ranks among best employers in Portugal

May 21, 2024

The new company, which will be located in Portugal, will focus on the development of drug delivery solutions for emerging drug modalities. Cell and gene therapies represent a paradigm shift in modern medicine, offering unprecedented opportunities to address previously untreatable diseases. ViSync solutions will help address some of the manufacturing challenges caused by the complex nature of new modalities, with special focus on stabilization, cell or tissue targeting and drug payload delivery.  Lisbon, 9th May 2024 – The specialist integrated CDMO and leader in pharmaceutical spray drying and particle engineering, and iBET (Instituto de Biologia Experimental e Tecnológica), a private not-for-profit research intensive SME in the area of Biotechnology and Life Sciences, today announced the creation of ViSync Technologies, a new joint venture located in Oeiras, close to Lisbon. The newly formed company will focus on developing innovative technologies and scalable solutions to help pharmaceutical companies address formulation and manufacturing challenges in transformative cell and gene therapies. Hovione has a strong track record in industrializing new technologies and supporting Pharma Companies with their clinical and commercial volume manufacturing needs, while iBET has a strong biological background and a global reputation for its scientific knowledge of the new therapeutic modalities space, particularly cell and gene therapy.  New modalities, such as gene and cell therapies, RNA drugs and other complex biologics, are a rapidly growing segment of the pharmaceutical industry. They promise to bring breakthroughs to the treatment of a wide range of diseases and conditions, including cancer, genetic disorders, rare diseases and neurological conditions.  While this rapid growth has been driven by remarkable efficacy in addressing unmet clinical needs, the complex nature of the new modalities brings challenges, including limited drug administration options, immunogenic responses and off-target effects, issues with high dose delivery and high costs. The poor stability of these drugs is also an issue, resulting in the need for cold supply chains. ViSync will aim to develop novel technology platforms to address the unmet needs of pharmaceutical customers developing these transformative new products. “The creation of ViSync in collaboration with iBET marks an exciting new chapter in Hovione´s commitment to innovation”, said Dr Jean-Luc Herbeaux, Hovione´s CEO. “New therapeutic modalities have the potential to bring radical improvements to current standards of care and we are thrilled to partner with iBET, a world-renowned expert organization in this area, to develop technology platforms that help customers bring transformative therapies to patients worldwide. The first step will be to assemble a team who possesses the knowledge, expertise, and ingenuity needed to navigate the complexities ahead." “The establishment of ViSync in partnership with Hovione represents a pivotal moment in iBET’s dedication to pioneering research in advanced therapies,” stated Dr. Paula Alves, iBET’s CEO. “The immense promise of these new modalities is at our reach and we are delighted to join forces with Hovione, a globally recognized leader in technological industrialization and drug delivery. In this common endeavor, we will gather the scientific and technical competences and skills to support our clients and partners in delivering groundbreaking therapies to patients globally.” ViSync will develop its own lab facility in Lisbon and expects to be able to start its research and development work by the end of 2024.   About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices.     Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About iBET iBET is a private non-profit institution devoted to biotechnology research, with 35 years of experience creating and transferring knowledge to the global biopharma and biotech sectors. iBET’s core expertise lies on the development of bioprocessses and analytical tools for Advanced Therapeutic Medicinal Products (ATMPs), including cell and gene therapies, vaccines, antibodies and other innovative therapeutic products. Leveraged by the emerging areas of Data Science and Translational Immunology, we offer bespoke R&D services from early-stage R&D to GMP manufacturing.  iBET’s infrastructure comprises cutting-edge laboratories, a GMP certified Analytical Services Unit, and a Late-Stage R&D and Bioproduction Unit, covering upstream and downstream process development, bioanalytical tools for critical quality attribute monitoring, to scale-up and tech transfer. iBET also hosts satellite laboratories of major pharmaceutical companies and serves as an incubation platform for start-up/spin-off companies. iBET is driven by its innovative and agile culture of continuous improvement and a strong sense of ambition, ownership and commitment in developing and delivering the best solutions to our stakeholders.  

News

Hovione and iBET announce the creation of ViSync Technologies, an innovative new company that will develop solutions for unmet needs in cell and gene therapy

May 09, 2024