To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.
“Digital transformation” is a common buzzword across industries today, but is it more than just jargon? Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.
It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages, including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiency, ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and availability of production systems capable of generating high virus titers.
The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?
With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.
A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification.
With mergers/acquisitions and cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.
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