< Previous20 Pharma Business International www.pbiforum.net Evolving the production line Evolving the production line 20-23.qxp_Layout 1 12/10/2021 13:48 Page 1EFFICIENCY AND OPTIMISATION Pharma Business International 21 www.pbiforum.net The possibilities offered by the fourth industrial revolution to the pharmaceutical industry are among the most exciting, with 3D printing technology enabling scientists, healthcare professionals and medical manufacturers to custom print everything from synthetic bone, to pills and precision equipment. We can all benefit from the promise of personalised medicine that 3D printing is eventually able to offer, but for manufacturers, the future is now with the gains to efficiency and optimisation already a reality. 3D printing is a long way off replacing the traditional medicine manufacturing line, but these first tentative steps are certainly heading in the right direction. Before manufacturers bypass the production line for downloadable alternatives instead, there are still plenty of obstacles to overcome in the present. 3D printing works by building an object layer by layer, meaning this level of precision could be used to print drug tablets with a dosage personalised to a patient. It could even combine several drugs into a single dosage so that patients taking a variety of medicines would now have to rely on a single pill. Beyond precision 22 Á 20-23.qxp_Layout 1 12/10/2021 13:48 Page 2EFFICIENCY AND OPTIMISATION 22 Pharma Business International www.pbiforum.net medicine, there are a great number of other applications that could greatly benefit from this technology. Orphan drugs can be limited due to its market size being too small to justify production costs. 3D printing, however, could be used to minimise the cost. There’s also other financial gains to be had in processing, with tablets being able to be printed in smaller lots, rather than produced in bulk and potentially leading to wasted or detective medicines. Although personalised medicines and even 3D printed organs are still currently in development, there are already a variety of commercial 3D printed products in areas including dental implants and tailored orthopaedics, among others. Funnily enough, one of the biggest hurdles isn’t technological, it’s regulatory. It might come as no surprise that the current framework that governs the manufacturing process is far from conducive to a culture of development, continuous improvement and invention. Although there is a clear prominence on design, it’s somewhat stagnating. The industry should be allowed to commercialise process improvements, in terms of yield, process and operating conditions, operating parameters or cycle time, in the manufacture of approved APLs and their formulations with the need of regulatory re-approval. Just this seemingly simple change would 20-23.qxp_Layout 1 12/10/2021 13:48 Page 3Pharma Business International 23 www.pbiforum.net EFFICIENCY AND OPTIMISATION © Shutterstock /i viewfinder grant manufacturers more responsibility in ensuring that their changes won’t affect a products efficiency and/or performance. Automation is par for the course in terms of any production line. From food to pharma, automation is increasing efficiency and replacing fallible human workers. The logical conclusion of automation is a robotic workforce. Increasing efficiency throughout production labour and equipment is a crucial way that top drug markers break out of the herd. The difference between the top tier companies and the average, as outlined in the findings, was two- thirds processes related. For example, lower performers are much less likely to adopt standardised way of measuring and controlling equipment parameters. The knock on effect from this stance, of course, is a greater yield of wastage from unplanned speed losses caused by line stoppages. Identifying the gap between the industries best and average is a means of improving efficiency across the board. Until production lines are a relic of the past, and personalised medicine is downloaded on-demand, the manufacturing process must be nurtured for best practice and efficiency without stilling innovation and developments going forward. Pharma’s future might be enigmatic at best, but it’s certainly looking streamlined. 20-23.qxp_Layout 1 12/10/2021 13:48 Page 4PPE 24 Pharma Business International www.pbiforum.net Pushing PPE forwards The essential role PPE plays is now recognised more than ever and as a result, it is evolving. 24-27.qxp_Layout 1 12/10/2021 13:49 Page 1Pharma Business International 25 www.pbiforum.net PPE Magnified by the pandemic, the importance of personal protective equipment (PPE) cannot be mistaken in its role as protector against chemicals, bacteria, viruses, and other various hazards. As COVID-19 hit, PPE manufacturers had to meet the challenge of protecting frontline workers and all other sectors, while some pharmaceutical firms pivoted to make the protective equipment themselves and meet shortfalls. Demand for these products surged, creating a global shortage, at a time where employers were already paying more attention to occupational health and safety, and policies across the globe, for example, wearing face masks, have continued to drive sales. The pandemic has propelled forward the evolution of PPE, which covers a wide breadth of items, from safety goggles and face shields to ear plugs, gloves, and shoes. This has occurred on a smaller scale, such as requesting or manufacturing face shields with softer padding to prevent pressure sores experienced with prolonged wear by NHS workers, to a wider look at the sector, at how certain products are used and how this effects the world. For instance, more focus has been placed on the decontamination, reuse and reprocessing of some types of PPE, particularly in response to a desire to promote sustainability, to minimise the carbon footprint and environmental costs connected to PPE. A plethora of reprocessing methods have been tested and evaluated around the world - with decontamination methods like treatment with hydrogen peroxide vapour, ultraviolet light, moist heat, dry heat and © Shutterstock /Maridav 26 Á 24-27.qxp_Layout 1 12/10/2021 13:49 Page 2PPE 26 Pharma Business International www.pbiforum.net irradiation - with some even now up for awards, and sanitisation has shown its potential to be more cost effective than manufacturing new PPE while significantly reducing pressure on supplies and waste. The latter is especially important with so much plastic waste being disposed of and incinerated. Simultaneously, PPE manufacturers are looking to source materials responsibly, are making use of bioplastic, are employing innovative manufacturing methods to save plastic, and when shipping are using compact packaging to cut carbon emissions. Furthermore, during the pandemic, researchers have created medical gowns with viral protection made from paper laminated with a coating of polyethylene, a lightweight thermoplastic, in reaction to mass shortages, poorly manufactured PPE and the misuse of PPE, aiming to create a simple, cost-effective, and industrially scalable solution to keep health workers and patients safe. Monash University says the breakthrough could see the mass rollout of high-quality PPE to vulnerable communities across the world. Of course, PPE has always been vital, especially in the pharmaceutical industry where people face a range of workplace hazards every day (chemical, biological, physical), and much like every aspect of the sector, it is an area seeing innovation. More is being invested in research and development for PPE to ensure the highest levels of quality, employee safety, and what is now more important after the pandemic added extra hours and strain to the pharmaceutical and healthcare sectors - comfort. While raw material, design and manufacturing innovation is taking place, PPE is becoming more “high-tech” with wearable technology. Helping to boost productivity and safety, certain forms of PPE are being enhanced with sensors that monitor myriad factors including analysing the external environment, protecting wearers, and alerting them to dangerous situations, which can also prevent accidents. On a simpler level, as an industry where roles require intense concentration, repetitive movements, long periods of standing and awkward postures, pharmaceutical firms are turning to PPE that can offer comfort, breathability, and improve wellbeing: factors that affect performance. Well- fitting PPE that does not irritate the wearer is key here. Offering better foot protection, which is often overlooked, can have a significant effect on employees who are frequently standing, an activity that impacts the feet, causes fatigue, and decreases concentration. Certainly without good foot support, repetitive tasks and constrained postures can heighten the risk of musculoskeletal disorders. To counteract this, ergonomic shoes that support employees are being provided. Meanwhile, in terms of eye protection, the need for safety spectacles with anti- fog coatings is well known, to protect the eyes from dangerous substances and keep vision clear, but eyes are also vulnerable to other, lesser thought of hazards like blue light, which employees are exposed to through LED lighting and the use of screens at workstations. Blue light can have many negative impacts on the eye causing headaches, eye fatigue, impaired concentration and even (at its worst) retina damage. To impede this, safety spectacles that absorb harmful blue light can be worn and employees will have comfortable vision. 24-27.qxp_Layout 1 12/10/2021 13:49 Page 3Pharma Business International 27 www.pbiforum.net PPE © Shutterstock /vichie81 24-27.qxp_Layout 1 12/10/2021 13:50 Page 4COLD CHAIN 28 Pharma Business International www.pbiforum.net All eyes on the cold chain While new public attention is brought on the cold chain due to the distribution of vaccines during the pandemic, the room for improvement is as clear as ever. 28-31.qxp_Layout 1 12/10/2021 13:51 Page 1Pharma Business International 29 www.pbiforum.net COLD CHAIN The complex pharmaceutical industry cold chain has gained new eyes as a result of the COVID-19 pandemic, with articles found across mainstream news covering the difficulties of transporting and administering vaccines for the novel coronavirus. With COVID-19 jabs needing to be kept at temperatures as low as -80?, the supply chain has been presented with a challenge - particularly in low- and middle-income countries. The stakes have increased, and an already growing demand for cold chain capacity pre-pandemic - due to an expanding requirement for drugs of all kinds, more approvals of cold storage drugs and the development of biologic therapies, novel oncology treatments and cell and gene therapies - has been added to. Cold chain logistics has a huge role outside of the pandemic of course as a vital component of the entire industry, maintaining integrity of highly sensitive pharmaceuticals as they are made, stored, distributed and transported. Products sensitive to high temperatures can become less effective and even toxic, while those sensitive to low temperatures often lose their therapeutic properties if frozen, with both of these having a major effect on health. The cold chain must therefore be guaranteed at all times, but there are a plethora of instances in which a product can be exposed to temperature variance, from unloading and loading, to poor packaging and events where equipment or transport breaks down and doors critical to sealing an area get damaged or are ineptly maintained. With the biopharma industry said to lose $35 billion annually because of failures in temperature-controlled logistics, more still needs to be done to mitigate this. Global spending on the pharmaceutical 30 Á 28-31.qxp_Layout 1 12/10/2021 13:51 Page 2Next >