Downstream Processing in the Age of Precision Medicine: Trends and Challenges

In the last two decades, the research and production of drugs have experienced seismic change, moving from highly tailored biologics and cell and gene treatments to mega-small molecules. These medicines don't require the types of large-scale manufacturing processes that many businesses and contract development and manufacturing organizations (CDMOs) have developed since they get constructed for real-world data advanced analytics.

This article discusses health economics and outcomes research where research is necessary, that is, downstream processing.

Drug Development | Trends

New Medication Delivery Systems

Precision medicine focuses on providing personalized medical care to each patient to enhance results and minimize adverse effects. Over the past two decades, this discipline has evolved quickly because of highly selective biologics and innovative treatment modalities comprising bi-specifics, trip specifics, antibody-drug conjugates (ADCs), cytokines, and customized cell and gene treatments (CGT). Each of these modalities brings new manufacturing difficulties, many of which are connected to the strength of the medicines.

Technologies With A Single Usage

The efficiency and procedures of downstream production have also been affected by the growth of "disposable" single-use technology. Reactors, membranes, and single-use chromatography systems reduce the need for time-consuming cleaning procedures, providing businesses and CDMOs more flexibility to manage various projects. They can more easily replace single-use goods and transition to a new treatment for manufacture on a smaller scale. This capacity to switch between processes lessens cross-contamination, improves bioburden management, and guarantees that businesses make high-purity goods by real-world data advanced analytics. Overall, single-use solutions increase operational efficiency by reducing the time and resources needed for clean-up and setup between different medications.

Upstream Processing Ongoing

Continuous chromatography procedures are essential for producing high-purity products in continuous bioprocessing. While loading gets done in the first column, the other steps—washing, elution, regeneration, and re-equilibration—get done in the other columns. It is known as a continuous chromatography process. Research that compared the costs of conventional batch processing with constant processing for the manufacturing of 200 kg of monoclonal antibodies (mAbs) discovered that the latter lowered the outlay of goods for downstream processing by around $9/kg.

Precision Medicine's Transition

Technologies such as next-generation sequencing (NGS) offer essential new perspectives on the causes of disease- 6, 7, and how people react to treatments. This knowledge has ushered in a new age of precision medicine during the past two decades, focusing on particular cancer mutations or disease-specific pathways in uncommon or autoimmune disorders. These so-called "orphan" pharmaceuticals are often created in limited quantities since they are treatments that cure diseases in a specific demographic.

Drug Development | Challenges

Issues That Arise In Supply Chain

While competing for production space with larger-scale pharmaceuticals, smaller biotech and biopharma businesses, without in-house manufacturing capabilities, rely on CDMOs risk getting ranked lower or paying a higher price.

Many organizations are proactively finding a second source for essential commodities to help reduce these risks. Manufacturers should look for backup goods that contain a resin or membrane that is similar if they need a particular polish to remove a known impurity, for instance. Companies may find it easier to meet deadlines for clinical studies or the most vulnerable patients if they have more security.

Facility Fit Concerns

Facility fit is indeed a difficulty, and future thinking is required. A high number of manufacturing partners get curated for standardized or generic processes comprising far higher capacity. Finding partners that provide a range of operational sizes and offer services for pharmaceuticals that need high-potency handling and integrated processes, as well as analytical development and release activities, is laborious. It can also get laborious to find a manufacturing partner who can manage IND-enabling activities and production requirements under tight deadlines. majority

Conclusion:

From 2022 to 2030, the size of the global downstream processing market is expected to increase by 15.0%.

Therefore, bottlenecks will be reduced, and productivity will eventually scale higher as biopharma producers continue to look for alternative approaches to optimizing downstream processes and adopt solutions that prove to be the most viable and effective. As manufacturers turn their attention to advancements in precision medicine, patients will eventually have access to a great selection of treatments for different kinds of illness conditions, which will have a favorable effect according to health economics and outcomes research.