On a commercial scale, biological molecules and materials are produced within the living systems like micro organisms and cell cultures through biomanufacturing. In the 1970s molecular biology was inculcated in biomanufacturing which made the genetic recombination of microorganisms like E.Coli possible.
This resulted in obtaining several important drugs like insulin. It is a rapidly progressing industry with tremendous growth potential. In the coming future, biomanufacturing is moving towards generation of standardized health care products. This includes cell therapies, genetic engineering, new medical devices like 3D printing, innovations in already formulated processes like downstream and upstream development biotech, as well as discovery and research.
Building Good Manufacturing Practice (GMP)
The essential reagents for vaccines, drugs and antibodies are manufactured in GMP facilities. In future, there will be more investments to support research and development with facilities and upgrade manufacturing and engineering to enable better GMP biomanufacturing. Upgrading GMP facilities include improving the infrastructure, increasing the quality of management and reform expertise. Part of this trend will include installing a fill/finish facility which is in worldwide shortage. GMP training is also part and parcel of this capacity build up.
Distributed Production:
There is an increased inclination towards manufacturing of raw materials for vaccines and therapies in distributed industries instead of in a centralized facility. It has many benefits including exploration of multiple new undertakings without being restricted by manufacturing constraints in one place. These new initiatives are the best shot at stumbling upon important innovations. A distributed approach ameliorates the supply chain issues and makes it easier to control quality and ensure homogeneity.
Increased Productivity:
Biomanufacturing productivity is increasing by leaps and bounds in the present especially in the form of upstream titers and to a lesser extent in the form of downstream yields. The titers for monoclonal antibody production has increased upto 3.53-3.96 g/L in 202 which is a radiant success as compared to titers back in 1980s which amounted to less than 10 percent (100s of mg/L) of the present amount.
Hiring Challenges:
As the biomanufacturing industry expands, there have been some challenges in hiring new employees. According to a survey, the most difficult position to be filled is downstream process development staff. Next to this is process development staff. Due to the hiring problems, more and more companies are investing in streamlining their processes, making them more efficient and automated; hence’ less expensive. It will take some burden off the already reduced staff.
The Holistic Approach:
The world is rapidly moving towards personalized medicines. The developments in biotechnology and biomanufacturing have changed the way many diseases are classified and treated. Personalized medical products will be manufactured according to specific needs of a particular patient. Advanced manufacturing techniques along with effective drug delivery systems and drug device combinations are necessary for this new innovation to work. Investment in biomanufacturing will ultimately lead to cost reduction and democratization of medical breakthroughs for the next generations to come.
Advanced Bioreactor Technology:
Bioreactors are crucial in biomanufacturing and the improvements and innovations in this area are essential for overall growth of the industry. The research and development spending on bioreactors is speculated to increase sharply in the coming future. The challenge of mass transport, bioreactors for large scale production, incorporation of disposable sterile bag systems, improved human and industrial factors are some of the areas where bioreactor technology has potential to be worked on.
