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Single Use System: Future of Biopharmaceutical Industries

Overview

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Date: 27 Jul,2022

Introduction:

Biopharmaceuticals include a wide range of products, such as vaccines, therapeutic proteins, blood and blood components, and tissues. In contrast to small molecule chemically synthesized drugs, which have a well-defined structure, biopharmaceuticals derive from living materials (human, animal, microorganism, or plant) and are much larger and more complex in structure. Because biopharmaceuticals work with the immune system and do not contain chemical-based drugs, there is a rapidly expanding acceptance of biopharmaceuticals to treat a range of diseases, and the market is growing quickly. The biopharmaceutical method of making drugs is an especially high-profile topic due to the global COVID-19 pandemic and the use of the mRNA vaccine, which is made using the biopharmaceutical process.

Single-use systems represent the future in biopharmaceutical processing of therapeutic drugs with significant advantages over traditional reusable stainless-steel systems and partly disposable systems. Seemingly the antithesis to a whole world trying to move away from disposable products and processes, Single-use systems promote sustainability by eradicating the chemicals and resources, like water and energy, needed to sterilize reusable systems. Perhaps, most importantly and critically, this is with little cost and process time, and virtually eliminates the risk of cross-contamination, since the product flow path is discarded and replaced after each batch.

Manufacturing process systems:

In biopharmaceutical industry, three types of processing systems create therapeutic drugs molecules.

Stainless-steel system: These are reusable, durable, and able to withstand exposure to the chemicals used to sanitize pharmaceutical processing systems, usually at extreme temperatures.

This necessitates stringent sterilization regimes potentially involving harsh chemicals and steam, resulting in considerable energy consumption to bring systems up to the extreme temperatures required for effective sterilization.

Partly disposable systems: These utilize some parts of the processing system more than once, depending on the therapeutic produced. Reused parts undergo cleaning and sterilization regimes like those used in stainless-steel systems, and maintenance is required as reusable elements deteriorate over time. Both stainless-steel systems and the reusable parts of disposable systems have the inherent risk of contamination, even with validated cleaning and sterilization programs.

Single-use systems: Single use products designed for use for the duration of the production process of a single batch of therapeutics and then discarded. Single use products manufactured in a cleanroom, double bagged and then sterilized by gamma or x-ray sterilization methods, these systems ensure a sterile system for every batch, as well as being highly efficient and cost effective.

Benefit of Single Use System

Reduction in:

1.Cleaning

2.Sterilization

3.Engineering cost

4.Equipment lead time

5.Utility requirements

6.Validation Activities

7.Quality / Regulatory burden

8.Space

9.Labour

Improvements in:

1.Manufacturing quality

2.Capital investment

3.Facility buildout time

4.Cycle time

5.Flexibility

6.Environmental impact

7.COGS

Anatomy of Single Use System:

A solution toward Single Use Systems:

Ami polymer offers wide range of gamma irradiated single use assemblies for various critical applications in biopharmaceuticals. These are range from simple tubing with connector to complex manifold with several joint/connection. All the assemblies are manufactured and packed in Class 7 certified clean room. We cover the whole upstream and downstream bioprocess, ranging from laboratory scale and pilot plant scale to production scale. Few applications of upstream and downstream production in Biopharmaceutical industries where Ami polymer supplying assemblies listed below:

1.Buffer and media transfer (feeds, the addition of base/acid, antifoam, growth medium, and other liquids),

2.Collecting samples with zero risk of contamination assemblies,

3.Media filtration assemblies,

4.Inoculation assemblies,

5.Removal of liquids from bioprocess assemblies,

6.Carboy/bottle assemblies for cell culture,

7.Product Filtration assemblies,

8.Filter manifold assemblies

9.Single use bioprocessing bag assemblies and

10.Peristaltic pump tube manifold assemblies.