Optimize Biomanufacturing Facility ROIC

Download the PTSI white paper and learn from PTSI’s 35 years of expertise.

 

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A Guide to Biomanufacturing Facility & Site Design: Optimize ROI via Purposeful Design

Whitepaper

Pharmaceutical Technical Solutions, Inc. (PTSI), a leading US-based biomanufacturing facility design, construction management, and CQV services firm, has just published a white paper outlining key considerations and learnings that can help you maximize the ROIC of your next facility.  Backed by PTSI’s facility design expertise and real-world data, the white paper highlights a clear opportunity to improve capital efficiency and accelerate time to market by removing in-house high-purity water systems, and media and buffer prep suites.

 

By focusing the biomanufacturing facility on core drug substance and drug product manufacturing, biomanufacturers can realize:

      • 17% average CapEx savings by reducing infrastructure scope (Table 2, p. 11)

      • 20–25% lower ongoing OpEx, due to reduced utilities, labor, and compliance requirements (p. 12)

      • 3–4+ months acceleration in CQV timelines, enabling earlier production starts (p. 10)

GeminiBio – PTSI’s Qualified Supplier

GeminiBio is proud to be one of PTSI’s qualified suppliers and is committed to supporting the success of PTSI’s biologics and advanced therapies clients via outsourced upstream and downstream process liquid manufacturing.  GeminiBio is uniquely positioned to improve biomanufacturers’ speed, agility, and operational efficiency, with capabilities including:

        • ISO 13485:2016 certified and cGMP compliant upstream and downstream process solutions

        • Highly scalable capabilities with cGMP lot sizes ranging from 10L to 10,000L, and fill sizes ranging from 500mL bottles to 1,000L pallet tanks

        • Segregated AOF and AO manufacturing facilities to support diverse upstream and downstream solutions

        • cGMP warehousing, including –20°C, 2–8°C, and CRT

        • Custom buffer formulation support and validation runs to meet release specifications and regulatory requirements

        • Stability study design and management for accelerated and real-time data to support development and commercialization

        • Scalable partnership model enabling clinical-to-commercial supply through a single supplier and quality system

    Explore Media and Buffer Prep with GeminiBio

GeminiBio is proud to be one of PTSI’s qualified suppliers and is committed to supporting the success of PTSI’s biologics and advanced therapies clients via outsourced upstream and downstream process liquid manufacturing.  GeminiBio is uniquely positioned to improve biomanufacturers’ speed, agility, and operational efficiency, with capabilities including:

        • ISO 13485:2016 certified and cGMP compliant upstream and downstream process solutions

        • Highly scalable capabilities with cGMP lot sizes ranging from 10L to 10,000L, and fill sizes ranging from 500mL bottles to 1,000L pallet tanks

        • Segregated AOF and AO manufacturing facilities to support diverse upstream and downstream solutions

        • cGMP warehousing, including –20°C, 2–8°C, and CRT

        • Custom buffer formulation support and validation runs to meet release specifications and regulatory requirements

        • Stability study design and management for accelerated and real-time data to support development and commercialization

        • Scalable partnership model enabling clinical-to-commercial supply through a single supplier and quality system

    Explore Media and Buffer Prep with GeminiBio