Top Challenges for Biopharmaceutical Process Development Industry in 2019

Biopharmaceutical is one of the most elegant and sophisticated achievements of modern science. The large, composite structures of these drugs look extraordinary in the 3-D modeling systems. Additionally, they also perform their tasks incredibly well, offering high value with fewer side effects.

Today, various multinational pharmaceutical firms are slowly moving to biopharma on a large scale. However, with this comes several challenges. Considering the growth the industry has seen and the intricacies of biopharma, it is not surprising that major changes are needed to equip laboratories and operations in biopharma.
Here are some of the major challenges that the biopharmaceutical Process Development industry is facing right now:
  • Some of the leading nations that produce biopharmaceutical drugs lack research components and best manufacturing practices. Pharma firms must be built in a way that they are equipped with the best operational facilities.
  • Cost pressure is expected to grow further as healthcare systems find it hard to balance growing demand with declining budgets.
  • The industry is mostly dependent on imports for raw materials for generic drug production. 
  • With the introduction of new process technologies such as continuous manufacturing and with a growing range of products, the complexity of biopharmaceutical process development and biopharma operations is likely to increase.
  • Functional testing laboratories are not widely present, which is critically needed to fast-track the specification work of raw materials.
  • The new categories of molecules, from drug conjugates to cell and gene therapies coming in the next five years, will require its biopharmaceutical manufacturing, quality assurance, and supply approaches.

  • Many pharmaceutical companies in India struggle to earn profits in comparison to their counterparts in countries such as the USA.
  • Quality functions are finding it difficult to cope with the growing demands of regulators. The industry is getting a record number of remediation programs and warning letters in the last five years, and the scrutiny is likely to continue.
The biopharmaceutical industry is moving to large molecule biological drugs from small molecule drugs. The sales have already touched $218 billion two years back, with a CAGR of over 8%. Biopharmaceutical medicines target disease pathways and offer greater value and safety. 
With biologics contract cGMP manufacturing, the previously untreatable diseases have become treatable. It has made biologics widely acceptable among people, driving the demand for investment in R&D. Biotech patents are growing each year at a rate of 25%. Presently, more than 33% of all new drugs in clinical trials are biologics and their success rates are higher than small molecule drugs. According to a survey conducted by global biopharma lab managers, 53% look to improve system efficiency and 56% stated gaining higher productivity and throughput in their labs as their main goal.

Moving from traditional pharma to biopharma can be very challenging. Biological drugs are intricate and tough to manufacture. Recombinant proteins are produced using genetically modified cells and cGMP manufacturing them frequently on a large scale is expensive. Controlling the manufacturing conditions and monitoring the protein production and cell growth is essential to maintain the quality of the drugs produced.
The industry today must produce the capabilities to reliably manufacture small batches of drugs needed to deliver cell therapies. Additionally, it requires the low-cost and high-volume manufacturing skills needed to deliver low-priced vaccines. Only with a combination of extensive operational excellence and science will the industry be able to change the health of a large number of people around the world, effectively steering both the challenging and promising elements.

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