< PreviousTEMPERATURE CONTROL 30 Pharma Business International www.pbiforum.net © stock.adobe.com/Aliaksei Unyielding integrity 30-33.qxp_Layout 1 08/12/2021 12:25 Page 1Pharma Business International 31 www.pbiforum.net TEMPERATURE CONTROL Maintaining the cold chain is vital to ensure the efficacy of vaccines and vital medical products. As well as an upsurge in growth over the last decade, the sector was called on in the safe delivery and transportation of COVID-19 vaccines. The role of temperature control in the pharmaceutical supply chain is utilised right across the life cycle of a medical or drug product. From manufacture to the delivery to an end user or patient, many of the products and substances are temperature sensitive, requiring specific parameters to stay stable, active and predictable. Currently, the global pharmaceutical cold chain logistics industry is worth $159.9 billion but, according to the latest figures, the industry is forecast to reach $585.1 billion by 2026. This substantial growth is being driven by strict requests for the increase in biologics in international life sciences shipments and demand in the wake of the COVID-19 pandemic (more on that later). Despite the surge in growth, emerging market challenges, from regulatory requirements to partner selection, put roadblocks up. The last decade has seen an upsurge in the number of logistics hubs worldwide, creating a more connected, around-the-clock pharmaceutical supply 32 Á 30-33.qxp_Layout 1 08/12/2021 12:25 Page 2TEMPERATURE CONTROL 32 Pharma Business International www.pbiforum.net chain. As biologics become ever more fragile and sensitive to a greater number of environmental factors, the industry needs to forge links for the sector’s overall wellbeing. Combining specialist packers with a temperature-controlled fleet, for example, will help alleviate the stress of product contamination or breakages whilst also ensuring sensitive materials stay within the desired temperature parameters. The need for temperature-controlled logistics in both the food and pharma sectors has caught the attention of mainstream transport companies looking to diversify their offering or expand their capabilities. Many of these companies are integrating cold trucks into their fleets, while some of the biggest players, such as FedEx and UPS, have entire branches dedicated to healthcare logistics. New technology is opening up new frontiers and opportunities for cold chain logistics, from driverless vehicles to greener fuel options, blockchain technology and other means of tracking and tracing. Being able to track a shipment in real time allows a company to follow a product through the supply chain, so should a problem arise, such as a fault in manufacturing, the shipment can be immediately located and stopped before delivery, thus preserving the health of patients. It can also allow for insightful analytics so any detriments to efficiency can be identified and rectified. There are limitations to road haulage and although arguments to the contrary, driverless technology is unlikely to lessen the strain of congestion and road accidents – certainly not for the foreseeable future. The unpredictability of road infrastructure can also wreak havoc © stock.adobe.com/philipus 30-33.qxp_Layout 1 08/12/2021 12:25 Page 3Pharma Business International 33 www.pbiforum.net TEMPERATURE CONTROL with tightly regimented schedules; so many pharmaceutical companies are increasingly turning towards ocean container lines to service their refrigerated supply chains. Air transport is an altogether more reliable and safer mode of transport, but it is losing a portion of market share from the global pharma products transport market due to a mixture of market challenges. There’s a lack of compliance, standardisation, accountability and transparency across the air transport supply chain, and annual product losses have been estimated as being anywhere between $2.5 billion and £12.5 billion. As the single biggest vaccination programme ever, the transportation and distribution of the myriad COVID-19 vaccines was a trial by fire for the pharmaceutical cold chain. Each vaccine may have a different profile, but what unites them all is the need for cold chain storage. This ranges from around –70°C during specialised shipping to around 2 to 8°C when administered. Some manufacturers are working on more thermostable versions of their vaccines, but, according to management consulting company McKinsey & Company, for now, countries are having to consider how best to plan for distribution to their citizens based on existing thermal- stability profiles and available supply- chain solutions. Though the market is vulnerable to regulatory challenges, the cold chain logistics industry is tipped for massive growth over the coming years. Along with logistics companies looking to diversify their offering and get in on the action, as well as the ever-expanding pharmaceutical industry, the future is looking cold indeed. © stock.adobe.com/Kaspars Grinvalds 30-33.qxp_Layout 1 08/12/2021 12:25 Page 4ALMAC PHARMA SERVICES Q&A 34 Pharma Business International www.pbiforum.net With the industry moving to more personalised medicine and delivering genetic material to patients to treat conditions resulting from genetic mutations, we speak to Sean Canavan, Operations Manager at Almac Pharma Services’ ATMP Centre of Excellence facility in Dundalk, on the impact this is having on the packing, labelling, and distribution of the specialised drug products. What are the ultimate differences in the packaging process for Advanced Therapy Medicinal Product (ATMP) compared to more conventional dosage forms? The ultimate difference for the packaging of ATMP is concerning the handling of the product and their special temperature requirements. Due to the genetic materials, these drug products often need to be stored at ultra-low temperatures, ranging anywhere from -20°C to -80°C and typically only have a very short window of time out of that condition, sometimes none at all. The time spent out of temperature can have a major impact on the efficacy of the ATMP and as such, maintaining the temperature must be kept in mind during the labelling and packaging process. How do you determine time out of temperature allowances? In general, this is a challenge faced by our clients. It’s difficult to run trials to establish allowable time out of frozen conditions due to the low volume, orphan designation, and extreme expense of the product. Our clients often have limited data when they come to us to commercially launch and pack their ATMP. Working with our client partner, reviewing whatever data they have available, we then devise a bespoke process to reduce the risk of temperature excursions as much as possible, and ensure that all goes smoothly once a solution has been determined. What are the key considerations for developing a packaging process for an ATMP? We have found that every client’s ATMP has unique requirements, which leads to very distinct packaging processes. So, we work collaboratively with our clients to define a robust and commercially scalable process that meets their needs, there is not a one size fits all answer. When working with our clients to determine a bespoke process, we will consider: * Temperature requirements (- 20°C, -40°C, -80°C) * Allowable time out of condition (ambient/dry ice packaging) * Conditioning time requirements * Material specifications for labels and cartons * Label design * Overprinting of labels and cartons * Final pack-out configuration (inc. ancillary components) * Level of serialisation aggregation required Is there any commonality amongst ATMP client needs? To be honest, not really. We work with a variety of ATMP, all with very unique processes. Though most are centered on using a dry ice solution, and to help prevent temperature excursions and limit the time out of condition, we pre- print as much as possible in terms of labels, cartons, and condition packaging components. I would say, one common requirement, is the need for responsiveness and the flexibility to be able to label, pack, and QP release the drug product as soon as an order is received. Quite often, we receive orders on one day and the ATMP is ready for dispatch the next day, or sometimes on the same day depending upon the time of order receipt. This responsive Just in Time (JIT) processing ensures the lifesaving drug product is with the patient as soon as possible. Q&A Exploring Ultra Low Temperature Packaging Solutions Q&A with Sean Canavan, Operations Manager, Almac Pharma Services 34-35.qxp_Layout 1 08/12/2021 12:26 Page 1Pharma Business International 35 www.pbiforum.net ALMAC PHARMA SERVICES Q&A Can you explain a bit more about the Just in Time processes at Almac? With Gene Therapies typically being patient specific, implementing a JIT process allows the product to be labelled and packed upon order receipt in line with that particular patient’s dosing requirements. For example, we have an ATMP where treatment is weight- based, and the weight of the patient translates into how many vials need to be packed. The product is for the EU market, so the product needs to be placed in country-specific packaging with the patient’s specific information on the pack and distributed accordingly. Between the varying weights and country information, at last count, this ATMP had over 420 SKUs for one product. For this particular product our client has a dedicated GMP footprint within our facility with reserved frozen storage resources. This is so that when an order is received which could be as niche as one vial per batch, our specialist team picks the product from the client dedicated freezers, labels and packs over dry ice, the product is QP released in real time and ready for distribution direct to the patient within 24-48hrs. What other key aspects are involved in ULT packaging for ATMPs? There are a number of expert teams across Almac Pharma Services which collaborate efficiently to ensure our clients receive a best-in-class, expedited and tailored solution for their individual product. For example, our Project team continually liaise with our clients to establish order requirements, scheduling and planning. Our specialist Quality teams ensure product integrity and documentation accuracy throughout the JIT process whilst our dedicated logistics teams provide the logistical expertise necessary to enable the safe transportation of the ATMP to its final destination on time and in optimum condition for the patient. For more information visit: www.almacgroup.com To contact Almac call: Global HQ +44 28 3836 3363 EU HQ +353 42 932 0718 Audubon, PA, USA +1 610 666 9500 Or email: pharmaservices@almacgroup.com About the Author: Sean joined the Almac Group in June 2020 as Operations Manager at its European Campus in Dundalk. He is responsible for the direct management of the Packaging and Logistics Operations at Almac Pharma Services’ ATMP Centre of Excellence Facility. With over 20 years’ experience in the pharmaceutical industry, Sean has been responsible in managing departments that have delivered multiple products in global markets including Europe, USA, Canada, Japan, Australia, New Zealand, Brazil, and Africa. Sean has extensive experience within the packaging industry and has worked very closely with some of the world’s biggest pharmaceutical equipment manufacturers over the years. He has also worked with some of Europe’s leading packaging suppliers to develop customer specific packaging solutions, helping launch client products on time and ensuring first to market. Prior to joining Almac, Sean worked for one of the world’s largest veterinary companies where he was responsible for the management of all packaging operations across several sites working with 300 products marketed in 110 different countries. 34-35.qxp_Layout 1 08/12/2021 12:26 Page 2PROMOTION 36 Pharma Business International www.pbiforum.net Pharmaceutical promotion at the time of social media and COVID-19 Pharmaceutical companies invest large capitals on the promotion of their products but the new challenges rising might be the proof that a new direction is needed 36-39.qxp_Layout 1 08/12/2021 12:27 Page 1Pharma Business International 37 www.pbiforum.net PROMOTION © stock.adobe.com/Halfpoint The pharmaceutical industry is not only one of the most profitable ones in the global market, but it is also an industry destined to be constantly and steadily growing in the future. Its global revenue was valued 1.27 trillion USD in 2020 and it will most likely register a growth in 2021, as a result of COVID-19 and the distribution of new therapies and drugs. The creation of a new medicinal drug requires a very long developmental time, there is a lot of research behind it, clinical trials and long manufacturing times, that involve expensive equipment and technologies. Making sure the new drug is marketed in the right way and it will reach healthcare professionals, first, and patients and customers, later, is a priority, and companies tend to invest more money on the promotion of a drug than they invest on the development and research to ensure high returns on investments. The pharmaceutical industry is also extremely innovative and constantly evolving. New drugs are being developed and produced every day and companies are constantly investing more resources in new research and in new equipment and expertise. The innovative nature of the industry makes it particularly competitive and companies, whether they are big established brands or small generic ones, need to constantly watch out for new and less expensive competitor drugs being released in the market. The competitiveness of the business drives it to be constantly innovating and developing new drugs, but the innovative 38 Á 36-39.qxp_Layout 1 08/12/2021 12:27 Page 2PROMOTION 38 Pharma Business International www.pbiforum.net © stock.adobe.com/Atstock Productions nature drives it to be competitive, creating a never-ending cycle of external and internal factors that put a considerable pressure on a company to invest in the marketing and promotion of their products. They want to make a profit and, because of all the competing players in the industry, they want to make sure their products are marketed at the highest of standards. Promotion and marketing are not easy in the pharmaceutical industry: it is all about finding the right messages, identifying the appropriate communicational channels and delivering engaging content that differentiate you from other companies. Due to the delicate nature of the products, pharmaceutical marketing is strictly regulated in most countries, and companies are not allowed to advertise directly to consumers, and instead focus all their marketing efforts on healthcare professionals. In the last couple of years, new challenges have developed, and between the rise of social media and a global pandemic, pharmaceutical companies have found themselves having to re- direct marketing efforts towards very specific directions. Social media platforms allow people to share their views, opinions and experiences on any subject without imposing specific filters on them. The pharmaceutical world is a very popular topic among social media users, but because of its very delicate and very personal nature, this popularity represents a risk for both single users and entire communities. For example, anti-vaxer propaganda has been dominating most social media forums for more than a decade now but, as a consequence of the COVID-19 pandemic and the release of the new vaccines, it is now on the news agenda on a daily basis. People can easily post misleading, or completely false, information across all kinds of platforms that can have a dangerous impact on people’s lives, and often resulting in promoting dangerous therapies, or counterfeit or black-market drugs. But because there are very strict regulations that dictate what information pharmaceutical companies can and cannot share and publish on social media, the misleading content reaches people with no or little supervision. 36-39.qxp_Layout 1 08/12/2021 12:27 Page 3Pharma Business International 39 www.pbiforum.net PROMOTION The main risk of false information is obviously to people’s health, but it has a very strong impact on the pharmaceutical market and revenue. Most pharmaceutical companies marketing strategies do not target the end-users, customers and patients, but instead focus on healthcare professionals and providers for doctors, pharmacies, and hospitals. However, healthcare professionals today are increasingly finding themselves facing patients who refuse determined prescriptions or demand something specific because of what they have read on the internet. COVID-19 has been a very good driving force behind these types of behaviours; people have been refusing the recommended therapies and asking practitioners to be prescribed drugs that could, in the best of cases, do nothing or, in the worst cases, be very dangerous of their health. Additionally, COVID-19 has been boosting the black market for counterfeit medicines and vaccines, resulting in an even bigger danger for public health. Misinformed people tend to reach their doctors and other healthcare professionals with all sorts of information and requests for medicines that will inevitably affect demand for certain drugs in favour of others and that can potentially cost pharmaceutical companies a lot of money. Unfortunately, despite their efforts to promote and marketing their products in the most efficient and successful way, pharmaceutical companies usually only have a direct line with healthcare professionals and providers and have little, if no power at all, on what kind of information is being spread across social media. Regulations about direct- to-consumer marketing are rightfully strict when it comes to healthcare information and drugs, as it could influence people’s behaviour on matters that require the consultation of a professional. However, changing these regulations in a way that would allow pharmaceutical companies to neutrally inform and educate their customers without influencing their judgment could not only help the spread of more responsible practices and better medicinal drug use, but it would also allow companies to redirect their marketing efforts on the real end-users and, hence, boost their profits. 36-39.qxp_Layout 1 08/12/2021 12:27 Page 4Next >