A menudo leemos que, en el mundo moderno actual, una de cada dos mujeres y uno de cada tres hombres desarrollará un cáncer durante su vida. Estas cifras ponen de manifiesto que el cáncer —del que existen más de 200 tipos diferentes— no es, en efecto, raro y es algo a lo que se enfrenta una gran parte de la población mundial en algún momento de su vida. Estas cifras varían según la geografía y la demografía; y, a primera vista, el panorama parece bastante aterrador. Pero, ¡no todo son malas noticias! Como resultado de los avances en la detección, el diagnóstico y el tratamiento del cáncer con terapias de vanguardia, muchos pacientes se recuperan de la enfermedad y pasan a llevar una vida normal. En el Reino Unido, por ejemplo, la supervivencia al cáncer está mejorando y se ha duplicado en los últimos 40 años. Ya no es una enfermedad terminal.

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.

Prevención y tratamiento

Desde un punto de vista mucho más positivo, los avances en los programas de cribado, las herramientas de diagnóstico, las tecnologías de imagen y los procedimientos de biopsia significan que la detección precoz aumenta masivamente las posibilidades de encontrar cualquier célula rebelde antes de que sea intratable. Si el cáncer se identifica en una fase temprana, antes de que aparezcan los síntomas, es más probable que los tratamientos funcionen y que más personas sobrevivan.

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.

El corolario COVID

Curiosamente, uno de los factores clave que permitió a los científicos desarrollar una vacuna de ARNm contra el coronavirus SARS-CoV-2 con tanta rapidez es que ya estaban utilizando el mismo marco para crear tratamientos similares para ciertos tipos de cáncer. La futura tecnología de las vacunas de ARNm podría permitir que una sola terapia proporcionara protección contra múltiples enfermedades e incluso utilizar estas “instrucciones de codificación de proteínas” para activar el sistema inmunitario y dirigirlo a células cancerosas específicas. Otras investigaciones han revelado cómo las células de nuestro sistema inmunitario se reúnen y comunican entre sí para identificar y erradicar los tumores, una idea que puede ayudar a mejorar estos resultados.

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.

Trabajar con la industria

GEA lleva mucho tiempo trabajando en el mercado de la oncología. Entendemos que la producción segura, eficiente y rentable de formas farmacéuticas para tratar el cáncer nunca ha sido más crítica para los fabricantes de productos farmacéuticos. De hecho, GEA puede proporcionar una solución especializada cuando no exista otra solución estándar, en particular para medicamentos citostáticos y oncológicos tóxicos o muy potentes.

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.

Más allá de la maquinaria

La protección de la salud y la seguridad de los operadores farmacéuticos es primordial. Con GEA, no hay duda de ello. Al mismo tiempo, ayudamos a las empresas a maximizar su producción, evitar onerosas pérdidas de productos y reducir los tiempos de ciclo. Las soluciones disponibles incluyen soluciones de contención sin EPI —desde las interfaces de manipulación de polvo hasta la compresión y el revestimiento de comprimidos— y desde HVAC hasta los sistemas de lavado y esterilización. Una adición reciente es la válvula de mariposa dividida BUCK^® AC, resistente a los disolventes, para la transferencia contenida de polvos activos de un recipiente a otro en entornos físicamente exigentes.

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.