The last four years have been a period of uncertainty and volatility the world over. This has especially been true of life science and biopharmaceutical industries, which have faced an extraordinary period of change and growth.
An unprecedented number of people have been affected by illness and chronic disease, and there has never been a higher demand for targeted, patient-centred treatments. And, just as vital, the tools and technology to meet that demand exist.
New demands on parenteral fill-and-finish production
This new reality has also meant a change in orientation for the CMO/CDMO landscape. The rise of highly targeted cell and gene treatments requiring small batch production at a record pace requires a new path forward for biologics manufacturing.
The demand represents good news: More and more people are getting life-improving and life-saving results from these innovative treatments. This also represents a high mandate for the pharmaceutical industry at large and for CMOs/CDMOs in particular. As a result, the sea change happening in the biopharmaceutical manufacturing sector has been profound.
CDMOs are now being looked to as leaders, asked to provide groundbreaking production solutions that are modular and flexible and able to produce a wide variety of recipes for novel cell and gene treatments with a complete range of fill and finish options.
And where there’s challenge, there’s opportunity. A recent report forecasted that the biopharmaceutical CMO market was slated to increase by as much as $51.5 billion by 2032, with American-led innovation and growth accounting for 34.2 percent of that projection.
Integrating flexibility with capacity in aseptic manufacturing
For CDMOs looking to meet the market demand, the considerations are many. Can low operating expenses be achieved and maintained? Can manufacturers optimise for recipe adaptation while keeping an operation scalable, from R&D through to commercial production, with minimal changeover time? Can CDMOs meet the product demands of their clients with zero compromise to cGMP regulations?
AST is here to help CDMOs answer those questions with a resounding “Yes!” The company supports the “small-batch revolution” with the latest in robotic and automated technology to provide aseptic solutions that are innovative and up to the production challenge, and the only product of its kind to be made in the USA.
The product line specialises in semi-automatic and fully automated aseptic fill-and-finish systems that produce sterile, ready-to-fill vials, syringes, and cartridges. Whatever the stage of the product lifecycle, both the ASEPTiCell and GENiSYS manufacturing solutions provide CDMOs with the adaptable tools they need to serve a diverse customer base.
The approach combines simplified, modular designs with advanced robotics to create a highly efficient, low-risk fill/finish solution. Minimal downtime. Minimal waste. Maximum flexibility. That’s how AST helps its CDMO partners meet the production demands of the now, and scale for a very exciting future.