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In our previous blog we discussed the latest trends in bioprocess resins, and how they will shape mAb purification in the biopharma industry in 2022. We don’t have a crystal ball, but we do have the expertise to suggest reasonable, practical steps you can take as a manufacturer to stay ahead of the game in mAb purification for 2022 and beyond.
Many of the challenges which started during the onset of Covid-19 will, unfortunately, linger through 2022. Labor shortages, supply chain issues and increasing competition mean innovation is needed across all areas of the biopharmaceutical industry for manufacturers and suppliers to continue to thrive. As such, new manufacturing techniques, business practices and strategies such as intensified bioprocesses, on-shoring and supply chain optimization are all key focuses to ensure the future remains bright for mAb bioprocessing. Here, we detail the 3 key areas to focus on in 2022.
At present, ports in the USA, Europe and other areas around the world are continuing to deal with record levels of congestion, and workforce shortages are hindering logistics providers in their ability to effectively move goods over land. Additionally, outbreaks of Covid-19 in key manufacturing hotspots, such as China, are causing shortages in labor, disrupting the production of vital raw materials and other product components. This is causing global challenges in procurement, disrupting supply chains, and hindering manufacturing on a global scale. Unfortunately, supply chain experts are predicting that these challenges will continue to be present for some time.
Supply chain resilience, then, is more important than ever for biopharma manufacturing. As a result, manufacturers are continually seeking ways to protect their supply chains against ongoing uncertainties, and other global threats. A key strategy larger manufacturers are employing is to source a second supplier of key raw materials, such as bioprocess resins, as well as ensuring suppliers either have domestic manufacturing capabilities or the ability to manufacture on multiple continents if necessary. This ensures supply risk is mitigated as much as possible, and offers maximum protection against ongoing global uncertainty. In 2022 and beyond, these new strategies could very well become the norm for globally leading manufacturers. We can expect pharma companies to continue to be discerning with their supply networks, and suppliers that can demonstrate an agile approach to addressing these supply chain reliability concerns will continue to thrive.
Increasing competition and industry demand are placing additional pressures on biopharmaceutical manufacturers. To cope with current and projected market conditions, intensifying existing processes will be vital. Whilst they’re reaching a gradual plateau, increasing upstream titres are also driving a strong demand for innovations in downstream purification processes. Currently, CAGR of mAb titres is 2.4% at manufacturing scale and 3.5% at clinical scales. Manufacturers will need to adopt processing methods that achieve sufficient speed, high throughput, and efficient use of facility space.
Considering these factors, it’s therefore vital that your resin has sufficiently high capacity to drive productivity, and that your process model is optimized to maximize capacity utilization – and therefore productivity - of your resin, within your existing facility fit if necessary. Like fine-tuning a car for maximum performance, your process parameters can be given minor tweaks which can make a big impact on performance. Implementing strategies such as continuous purification methods or goal-orientated process modelling such as SMART Cycling with Praesto Jetted A50 will ensure success in 2022.
As mentioned in the previous section, upstream titres currently have a CAGR of 2.4% at manufacturing scale and 3.5% at clinical scales. It’s therefore vital that your chosen resin (and supplier) is able to meet these demands both now and in the future, to account for that continual growth, and to mitigate manufacturing bottlenecks in downstream purification.
As an example, Purolite, are the only global supplier who focus 100% on resin manufacture and innovation. To address continuing demand for higher capacity Protein A resins, our Praesto products have increased in dynamic binding capacity by an average of 17.5% per year since 2015, culminating in the latest-generation Praesto Jetted A50 and Praesto Jetted A50 HipH affinity resins, which provide up to ~60 mg/hIgG/ml resin. These both utilize proprietary manufacturing technology from Purolite not found anywhere else in the agarose bioprocessing resin market to address key challenges and give unique performance benefits vs. competing technologies (learn more).
As global supply chain challenges and unprecedented demand for mAb therapeutics continue through 2022, to future-proof your process it’s important to select a supplier who is able to support you with high-quality products, diversified manufacturing across several continents, a global supply network and an ongoing commitment to innovation and improvement. For expert mAb purification support from clinical to manufacturing scales, contact a Purolite Technical Specialist today.