The passion started with a talk I attended with a speaker who very enthusiastically shared his experience of translating a CAR-T therapy from bench-to-clinic and the success story of treating an acute lymphoblastic leukemia (ALL is a malignant form of blood cancer usually in children) patient, Emily Whitehead. He was very animated and very proud of his involvement in the project, and reasonably so - Emily Whitehead was one of the first acute lymphoblastic leukemia patient treated back in 2012 and still in complete remission (i.e. the cancer didn’t come back). It was a powerful message that I hold very close to heart and I knew this is something I want to be part of.
Whilst scientists focus on finding out how things work and create theories, engineers are responsible for implementing them. Between a biochemist and a biochemical engineer, the biochemist may be responsible for discovering a new drug or a new form of energy, and the biochemical engineer finds a safe and cost-effective way of making the drug or biofuel. In the biopharmaceutical area, engineers actively seek to scale up laboratory-scale processes and look for cheaper and more efficient ways of making safe and effective therapies. The production of these therapies is highly regulated to ensure safety which adds an additional fold of complexity for the manufacturing of such products.
An illustrative example would be the commercialisation process of a bio-engineered cornea. In China, due to traditional beliefs, people are reluctant to donate their organs after death. There are currently more than 4 million people waiting for corneal transplants in order to regain their sight and the queue for corneal transplantation can be more than 2-3 years. A scientist in China discovered a way to remove cells in a pig’s cornea in order to produce an immunologically inert cornea. To commercialise such a product, there are several things engineers have to do. First, the manufacturing process must be robust and produce the same safe and effective product every time. Engineers look into ways to characterise the process, i.e. find out everything they can about the process such as the temperature and pH range that can be tolerated. This can affect the product quality, safety profile, yield and hence the cost of the product. After gaining enough process understanding, engineers look into ways of producing more at the same time and lower the cost per cornea. For instance, in the bio-engineered cornea manufacturing process, the decellularization of pig cornea was identified as the most labour intensive step. Therefore, engineers at the University of Oxford were commissioned to design an automatic process to enhance manufacturing efficiency. This allows several thousand pieces of corneas to be processed at once under the supervision of two operators only.
Secondly, the process must comply with safety regulations set forth by the government. The process must be conducted in a strictly controlled manner in a strictly controlled environment. Designing a facility to house such highly-controlled processes are highly specialized and bad designs can lead to contamination issues that can cause serious adverse reactions in patients. It all sounds like very difficult and meticulous work but the satisfaction of meeting patients that get benefitted from such work is unbelievable. Patients with serious corneal infections would come to hospitals with nearly no vision. Opaque botches or lesions on the cornea can completely block their sight and this causes a huge impact on the daily lives not just of the patients, but also of their families. I vividly remember meeting a patient who lost his job as a security guard due to a corneal infection and his joy of finally being able to see properly and take charge of his life again.
Whilst our universities rank highly in international research, these high-quality researches are not readily translated into products that benefit patients. Getting these products commercialised not only requires a good business model, but also skilled engineers that can develop the technology into a product and manufacture it in a safe and cost-effective manner. In Hong Kong, there are a few of pharmaceutical and biopharmaceutical companies in Shatin, Tai Po and Hong Kong Science Park that actively engage in manufacturing of drugs. The Hong Kong Institute of Biotechnology engages skilled engineers to provide manufacturing consultation services and scale-up expertise for biotechnology companies. Hong Kong Science Park serves as an incubation platform with plenty of biotechnology companies such as Novoheart which are developing bioartificial human heart prototypes and BioCell Technology Limited which provides contract manufacturing services for cellular therapies.
Biochemical engineering is a very niche profession which requires a scientific and analytical background. Problem solving and team-working skills are crucial in delivering a successful project. Whether it is building a facility that is compliant with safety regulations or scaling-up a manufacturing process from lab-scale, there are no lack of problems to solve and a lot of cross-functional discussions are required. For biochemical processes, you may have to talk to the biologists to better understand the physiological requirements in order to design the optimal manufacturing process. For facility design projects, you may need to talk to architects, electrical engineers, suppliers, regulatory experts, etc. to design a facility that can do what you need it to do whilst complying with local regulations. Being a very fast moving field, it is very important to keep up with innovations and advances in the industry. If you are up for the challenge and passionate about solving world issues using biology, why not consider biochemical engineering as a profession?
Written by Ms Gloria Lam from the Mechanical, Marine, Naval Architecture & Chemical Division of the HKIE
