03 Jan 2022
We often read that, in today’s modern world, one in two women and one in three men will develop cancer during their lifetime. These figures highlight that cancer — of which there are more than 200 different types — is, indeed, not rare and something that a large part of the global population faces at some point in their life. These numbers do vary according to geography and demographic; and, at face value, the outlook seems quite scary. But, it’s not all bad news! As a result of breakthrough developments in the screening, diagnosis and treatment of cancer with cutting-edge therapeutics, many patients recover from the disease and go on to live normal lives. In the UK, for instance, cancer survival is improving and has doubled in the last 40 years. It’s no longer a terminal condition.
So, what is cancer? It’s a disease in which some of the body’s cells grow uncontrollably and spread to other organs. It’s known as a genetic illness because it’s caused by changes in our genes (long strands of tightly packed DNA) that control the way our cells function, especially how they grow and divide. And, although the body normally eliminates cells with damaged DNA before they turn cancerous, our ability to do so goes down as we age. Huge steps forward in general healthcare around the world have resulted in longer life expectancies, better medicines and a higher level of overall well-being. But, as we age, the risk of cancer increases. It’s just statistics, but the reason why a larger number of older people succumb to cancer.
On a much more positive note, advances in screening programs, diagnostic tools, imaging technologies and biopsy procedures mean that early detection massively increases the chance of finding any rogue cells before they become untreatable. If cancer is identified at an early stage, before symptoms appear, treatments are more likely to work and more people survive.
As such, screening is critical. The process helps to detect cellular abnormalities before they can turn into cancer, making it easier to treat. By the time symptoms appear, the cancer may have grown and spread. One of the problems with cancer is that it’s unpredictable. But, researchers have taken advantage of this fact by developing therapies that target the atypical features of cancer cells. For example, some therapies prevent blood vessels from growing toward tumors, essentially starving the tumor of the nutrients it needs to survive.
Similarly, we know that the human papillomavirus (HPV) can cause genital warts and cervical cancer. Yet, because we’ve identified this virus as the source of these conditions, scientists have been able to develop a vaccine that, when routinely given to adolescent girls and boys of an appropriate age (which varies according to country but is usually administered between the ages of 9–14), has resulted in a 90% reduction in infection rates. And although only a few approved cancer vaccines exist at the moment, many others are being developed.
Interestingly, one of the key factors that enabled scientists to develop an mRNA vaccine against the SARS-CoV-2 coronavirus so quickly is that they were already using the same framework to create similar treatments for certain types of cancer. Future mRNA vaccine technology may allow for one therapy to provide protection against multiple diseases and even use these “protein-coding instructions” to trigger the immune system to target specific cancer cells. Other research has revealed how our immune system cells congregate and communicate with each other to identify and eradicate tumors, an insight that can help to improve these outcomes.
Surgical procedures have also made huge leaps forward: it’s no longer just a case of having to remove an entire organ or a whole breast, the development of minimally invasive techniques means that surgeons can effectively remove just the affected tissue, resulting in fewer side-effects and post-operative stress (particularly when combined with follow-up screening). Of particular note is the progress made by pharmaceutical companies; the number of clinical-stage cancer programs has risen steeply. For example, at the end of 2020, there were more than 2000 oncology drugs at various stages of the development pipeline. By comparison, therapies for infectious diseases were next with less than half that amount.
Growth in this market has been impressive, particularly in terms of treatments for orphan diseases that have a smaller population base, fast-tracked drugs to expedite time-to-market and the development of gene editing tools (such as CRISPR-Cas) and advanced therapy medicinal products (ATMPs) for extremely rare types of cancer. Which brings us right back to COVID. Because our own genetic make-up wasn’t able to fight off the coronavirus, we needed to enhance it with a vaccine. The same concept applies to cancer: from somatic cell therapies to tissue engineered products and autologous/allogeneic stem cell transplants, a whole host of technologies and treatments is available that includes surgery, radio/chemotherapy, tablets, liquid dosage forms and cutting-edge biologicals.
GEA has long been active in the oncology market. We understand that the safe, efficient and cost-effective production of dosage forms to treat cancer has never been more critical for pharmaceutical manufacturers. In fact, GEA can supply a specialized solution when no standard off-the-shelf one exists, particularly for toxic or highly potent cytostatics and oncology drugs.
Experts in aseptic process management, closed product handling, compliance with cGMP requirements, gentle product treatment and reliable scale-up, we supply modules, components and complete lines for the production of oncology drugs and other aggressive therapeutic agents. From basic engineering to fabrication and qualification, we have a solution that can be tailored to meet specific needs.
Capitalizing on GEA’s experience in the field of designing plant that’s able to safely handle highly potent drugs, for instance, Oncogen Pharma in Malaysia recently invested in an entire suite of equipment for the production of oral solid dosage (OSD) forms to treat cancer. The end-to-end solution comprises a MODUL P rotary tablet press, a granulation line, downstream processing and containment equipment. Not only has the company been able to grow its portfolio and capacity, the deal also represents GEA’s first key oncology reference in the Malaysian market.
Similarly, in India, Caplin Point Laboratories Ltd’s expansion plans included the installation of contained oncology production equipment to expand their reach and deliver the highest quality medicines. With a deadline in place and wishing to launch their first product by March 2022, speed was an absolute imperative. And, while talking to other oncology product manufacturers in India, they found that almost all of them were using GEA solutions. As a result, Caplin selected a complete end-to-end process line from GEA, including an integrated granulator, material handling equipment and a MODUL P tablet press to accommodate a working volume of 12–120 L.
Protecting the health and safety of pharmaceutical operators is paramount. With GEA, that’s a given. At the same time, we can also help companies to maximize yields, prevent expensive product loss and reduce cycle times. Available solutions include PPE-free containment solutions — from powder handling interfaces to compression and pellet coating — and from HVAC to washing and sterilization systems. A recent addition is the solvent-resistant BUCK® AC split butterfly valve for the contained transfer of active powders from one vessel to another in physically demanding environments.
The ConsiGma® line, GEA’s multipurpose continuous manufacturing platform, which has been designed to transfer powder into coated tablets in development, pilot, clinical and production in a single compact unit, offers significant benefits during the small-volume production of orphan drugs and is available for contained environment use. Tablet presses for cleanroom, contained and highly contained applications, including the production of single and bilayer tablets, are also available.
Beyond solid dosage forms, GEA also produces an entire range of equipment for liquid drugs, freeze-dried products and injectables. From therapeutic proteins to monoclonal antibodies (mAbs), GEA specializes in the planning, construction and qualification of sterile process plant for the pharmaceutical and biotechnology industries, including the VarioSys® production system for small batch applications.
With the rising awareness of the risk of cancer and, possibly as a result of COVID-19 that exposed our vulnerability as a species, there is a notable trend towards people taking a more proactive approach to preventive healthcare and improving their overall wellbeing. The global population is becoming increasingly aware of the benefits of a healthier lifestyle, such as eating a better diet, giving up smoking, weight/obesity management and taking more exercise. In the past, cancer was something that happened to other people. Now, it affects everyone.
At the same time, because of the progress we’ve made, the chances of surviving cancer have massively increased. There are many contributors to that fact, with researchers, scientists, doctors and suppliers of equipment, to name just a few, all playing key roles. It’s arguable that innovator pharmaceutical companies are the current heroes of the day. Or, by contrast, it’s those patients that have recovered from cancer or remain in remission that are the most inspirational influencers and drivers of change. Committed to engineering for a better world, GEA is proud to support the people, processes and practices that will continue to make all forms of cancer treatable, meeting the unmet needs of both current and future patients.