Pharmaceutical plants cannot be treated like real estate. Instead, they require a detailed assessment of where they are in “operational compliance and production readiness.”
In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.
Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills
The movement of viral vectors, cell therapies and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skill sets can help you maintain the right balance in your facility design to maintain flexibility which is essential to meet diverse processing needs for biopharmaceutical manufacturing.
We are internationally recognized as experts in advanced aseptic processing and risk-based isolation and barrier technologies. Our experience, awareness and understanding of industry trends places importance on time-to-market, plant flexibility and cost control to avoid costly project delays and minimize risk.
Whether the products are new or existing, our Drug Development and Technology Transfer services offer solutions that consistently maintain quality and compliance to effectively accelerate scale-up through market launch. Our experts provide ideas that speed pharmaceutical and biotech products to market.
Our team has the experience and technical knowledge to execute the most complex, demanding laboratory projects. Our unique approach combines the design elements with operational excellence, energy efficiency and risk and safety assessment as required to meet your laboratory needs.
Knowing the technology, industry trends, regulatory environment and manufacturing processes enables our process/bioprocess engineers to identify opportunities to streamline production and maximize efficiency.