Bioneedle Technologies Group is working on a smart and safer way to administer vaccines using biodegradable mini implants.
The existing way of delivering vaccines using needles and syringes poses many problems. They are painful to begin with; they have to be sterilized properly and must be disposed off carefully to avoid any contamination. And the vaccinators need to have a medical background and training to administer vaccines.
That’s not all. The biggest problem is managing the long cold chain that precedes the administration of the vaccine. The vaccines have to be stored at temperatures ranging from +20C to +80C throughout the vaccine delivery chain right from the manufacturer to distributor to vaccine depots to provider office and finally to the client. This raises costs, reduces efficiency, necessitates training and makes it difficult to vaccinate in hard-to-reach areas.
Now, a Dutch company called Bioneedle Technologies Group is working to change all this by radically altering the way vaccines are manufactured, stored, transported and administered. At the heart of this new technology is a novel and unique pharmaceutical polymer, using which very tiny, soluble and biodegradable implants – called bioneedles –are manufactured to deliver vaccines.
These needles measure 1.5 cm in length and are pre-filled with thermo-stabilized vaccines that do not require any refrigeration or cold chain management. The needles are then loaded into an applicator, powered by compressed air, which shoots the implant into a person’s arm without even making contact with the skin.
“When using the bioneedle system there is no need for the vaccinators to have medical background. The application of a bioneedle beneath the skin takes less than one millisecond which means that the application of bioneedle is pain-free,” says Dr. Gijsbert van de Wijdeven, Co-founder of the Bioneedle Technologies Group.
Once inside, the polymer starts absorbing the body fluids within seconds and dissolves within minutes, thereby delivering the vaccine. The delivery is safe, painless and has no contamination issues. A single bioneedle has the loading capacity to deliver multiple vaccines in one go.
Conceptually this may seem simple but it took more than a decade for the company to develop pharmaceutical-grade biopolymers, soluble bioneedles, thermostable vaccines and subcutaneous injectors. The technology development is now past the proof of concept at preclinical level and proof of principal at the clinical level.
The company also completed a Phase 1 study that demonstrated the safety of bioneedles on humans and is looking to secure FDA’s CGMP-compliant approval to its manufacturing processes to begin clinical trials with the actual vaccines. Van de Wijdeven estimates that it may take four more years to complete all the necessary trials and get to market-ready bioneedles.
The product may be years away but the idea is already attracting much appreciation. Bioneedles were one of the four path-breaking technologies identified by 700 for Science, a global nonprofit organization comprised of scientists, industry leaders and investors in early-stage biotech and clean technologies with potential far-reaching social impact, for its 2014 Portfolio 700.
Dr. Van de Wijdeven believes that the technology is suitable to develop all types of vaccines including protein-based vaccines, composite vaccines and RNA-based vaccines. If bioneedles live up to the expectations, they can potentially change the whole vaccine delivery system from end to end.
They produce zero biomedical waste, reduce preventable deaths from contaminated needles, do away with the cold chain and manpower training issues and help the government health service systems to vaccinate people in an efficient and effective way.