Single-Use Technology: Revolutionizing Biopharmaceutical Manufacturing

In the dynamic landscape of biopharmaceuticals, the need for agility, cost-efficiency, and compliance with stringent regulations has never been more pronounced. Single Use Technology (SUT) emerges as a transformative approach, reshaping the industry’s production paradigm. Let’s dive into how SUT is revolutionizing biopharmaceutical manufacturing and its impact on facility design and costs.

Addressing Industry Challenges

As the biopharmaceutical sector is evolving, it demands greater flexibility and responsiveness in production facilities. Single Use Technology emerges as a solution by offering:

  1. Flexibility: By decoupling the process train from facility infrastructure, SUT facilitates easy reconfiguration, enhancing process and product flexibility. It allows for faster batch turnarounds, enabling speed to market and rapid capacity expansion to meet increased demand.
  2. Reduced Capital Investment: Shifting the cost structure to variable operating expenses reduces capital investment by over 70%. This significant cost-saving potential applies to both equipment and facility infrastructures.
  3. Increased Speed: SUT accelerates facility construction, commissioning, and launch. With simplified handling and quick turnaround times, it eliminates the need for change-over cleaning and reduces validation requirements between different strains/products.
  4. Safety: SUT minimizes regulatory concerns and reduces validation requirements by over 50%, streamlining processes and lowering labor costs.

Enabling Single Use Technology

The evolution of SUT components and applications has been remarkable. From simple technologies like bags and filters in the 70s, SUT now encompasses all biopharmaceutical process operations, including cell culture, downstream processing, and fill-finish. Recent advancements have led to the availability of complex operations, such as large-scale bioreactors up to 2000 L capacity, and integrated systems offering complete facility solutions.

Impact on Facility Design and Costs

Traditional stainless steel facilities, while robust, are costly to build and validate. In contrast, SUT offers the flexibility to choose between traditional stainless steel, single-use equipment, or a hybrid combination of both. The introduction of SUT significantly reduces capital costs and cost of goods sold (COGs), as evidenced by a reduction of up to 48% in capital costs and 33% in COGs compared to traditional facilities.

Ultimately, embracing Single-Use Technology signals the dawn of a new era in biopharmaceutical manufacturing, characterized by heightened efficiency and unparalleled flexibility. Its capacity to amplify process adaptability, slash operational expenses, and expedite product launches positions SUT as an indispensable tool for companies striving to maintain competitiveness within the constantly evolving industry terrain.

Find Single Use Tecnology Equipment Ready To Use

EquipNet offers a great alternative for companies looking to embrace Single Use Technology. As a global MarketPlace for second-hand equipment, EquipNet offers potential buyers an extensive inventory of pre-owned biopharmaceutical equipment.  Purchasing new brings the chance of delays related to supply chain instability or potential manufacturing disruptions, but the pre-owned equipment market lends itself to a quick turnaround from purchase to delivery.

Here are some of our Top Projects in Europe and North America

EquipNet also offers additional shopping options to meet every buyer’s needs. Auctions allow potential buyers to find high-quality equipment that may not be otherwise available in our inventory. Own It Now is a platform where buyers can find assets available for immediate purchase, often featuring timed price drops.

Categorias: EquipNet , Pharma/Biotech , Uncategorized