Jeffrey Kemprecos, director of communications, government affairs, and market access at GSK-Gulf, and a biopharmaceutical-industry expert with more than twenty-five years of international experience, talked with Mike May, PhD, about the do’s and don’ts of working with foreign governments on biopharma projects.
Synthego has adopted Good Manufacturing Practice standards for producing customized GMP-grade synthetic guide RNA (sgRNA) at its facilities, an initiative the company said will benefit its academic and industry customers as they develop advanced cell and gene therapies.
Hackers continue to look for vulnerabilities in pharma IT systems. In particular, unprotected bioprocessing technologies are points of attack for hackers. All manufacturing systems with any form of programmable intelligence in them are hackable. Hacks can be direct via network connections or via local, USB, or file injection methods.
The company's line incorporates technologies designed to maximize yield and minimize risk, in order to safeguard every drop of API. Key line features include robotics, isolator technology, minimal hold up volume, and in-line nondestructive 100% weight checks.
Bioindustry experts say that that support and continuing advances in cell and gene therapy production will kick start innovation and novel approaches in vaccine manufacturing. In influenza vaccine production, the egg definitely came first. Right now, and for most flu shot manufacturing firms, eggs are still the standard production mode.
Sciar Company, which says its product could help manufacturers automatically log product samples and reagents and reduce the risk of errors in manual workflows, reports that the necessary applications for AR and cloud infrastructure for its software are already built but continue to be developed based on customer feedback from pilot studies.
To reduce complications with newly-emerging methodologies, companies are advised to interact with the FDA to get early feedback even before a drug or product candidate associated with their novel technologies is identified.
Univercells NevoLine delivers upstream, downstream and concentration steps in one platform, allowing for commercial scale manufacturing to be carried out using a benchtop setup, according to the company.
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