The Growing Future of Drug Manufacturing

Posted: 7 May 2024

Pharmaceutical Technology

April 2024, Volume 48, Issue 4, pp. 14, 16-17.

Continuous innovation in the pharmaceutical industry is leading to ongoing introduction of novel therapeutics and vaccines, many comprising new modalities that in turn are driving advances in drug manufacturing. Reducing the time and cost for drug development and manufacturing is also leading to new manufacturing solutions, as is a growing focus on personalized products.

Increasing pressure to bring new medicines to market more quickly at lower cost is being addressed through use of artificial intelligence (AI) for monitoring, predicting, and controlling processes, according to Daniel Spurgin, director of Strategic Partnerships at ReciBioPharm. To implement truly integrated facilities, however, improved IT infrastructure must be developed along with better data aggregation and analytics tools and automation solutions, according to Avi Nandi, head of US Cell and Gene Therapy, SK pharmteco.

Some of the biggest developments in manufacturing technology, says Melanie Langhauser, team lead of Process Development, DSP, and Analytical Development at Ascend Advanced Therapies, are focused on improving the productivity and efficiency of production processes while simultaneously boosting quality and reducing cost, particularly in the advanced therapies space.

Personalized medicines, meanwhile, require small batch manufacturing and tailoring of drug designs, observes Cyrill Kellerhals, COO, Andelyn Biosciences. For adeno-associated viral vectors (AAVs), solutions under development include new engineered AAV serotypes, cell lines designed to produce AAV vectors, more efficient transfection systems and offline assays, and purification technologies, according to Langhauser. Smaller filters and filter holders in single-use format and associated scale-down models are also needed.

Advances in technologies for production of critical raw materials needed to produce next-generation therapies are equally important, according to Spurgin. Cell-free plasmid DNA, for instance, could significantly reduce the time and cost need to manufacture mRNA, cell, and gene therapies. He also points to engineered enzymes as playing a key role in reducing the manufacturing time while increasing the quality of RNA therapies.

Advances such as those described above are needed to help biopharmaceutical companies realize the full potential of novel modalities including cell and gene therapies and mRNA products. In addition to viral-vector-based gene therapies, but CRISPR [clustered regularly interspaced short palindromic repeats]-Cas9-mediated gene editing of stem cells are making treatment of many diseases caused by genetic mutations possible, while mRNA technology represents a new approach for treating challenging diseases such as AIDS and cancer, notes Oladimeji Fashola, chief technology officer, Quantoom Biosciences.

As understanding of these myriad novel therapeutics and vaccines continues to expand, even more and widely diverse new technologies can be expected, from raw materials to cell lines, analytical and IT tools, automation and scalable production platforms, and delivery vehicles, to overcome manufacturing challenges and lead to safe and efficacious advanced medicinal products that are generated in less time, more cost-effectively and at the highest possible quality, Nandi concludes.