Manufacturing Procedure of Products of Bio-Works Company

Introduction

Biotechnology companies have has different types of departments like Manufacturing (Production), Quality assurance, Quality control, Research & Development, Microbiology, and financial & Procurement departments. Manufacturing (Production) department acts as the heart of the Company [1]. This department is responsible for converting raw materials and other recipients of finished products. All process to involve in the preparation of the product of the receipt of material through Processing, Packaging, and labeling with a finished product. The Manufacturing department provides guidance for the development of quality products in order to estimates that finished products could safe for animal and human use [2].

Some basic principles are manufacturing area would be clean and hygienic. The Area will be maintained by different environmental conditions to avoid cross-contamination from containment. Used processes should be controlled and if any marked changes in the procedure must be evaluated. Instructions and procedures should be written in an understandable and unambiguous language. During manufacturing Records must be prepared by manually or electrically.

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 Separation of the product could decrease the possibility of risk of their qualities [3].

Bio-works carry out R&D, manufacturing, and supply with agarose-based resins used to separate proteins and other biomolecules. Products of bio works are manufactured at ISO 9001:2015 certified Plant Locate in Uppsala, Sweden. Agarose is a polysaccharide that is carefully extracted from the seaweed species Gracilaria and flexible and elastic in nature [5]. The agarose base matrixes are chemically very stable and cost-efficient, and sanitization method based on sodium hydroxide. Agarose is used in molecular biology for the separation of large molecules by the process of electrophoresis [4].

Agarose manufactured as beads to use in various chromatographic methods of protein purification. They are gel filtration chromatography, affinity chromatography, ion-exchange chromatography. However, these are manufactured into beads or resins of different sizes. The prepared beads are porous, so the protein flow may be passing directly through the beads [3]. Principally, these agarose based beads are soft and crushed easily, so beads would be used under gravity flow, low-speed configuration, and low pressure. The key advantages of the resins are it can be developed by increase the cross-linking process and hardening of the agarose resins. Agarose is naturally, useful material for chromatography it did not absorb biomolecules to any flow properties and stabilized PH and ionic strength [8].

Procedure

Bio-works carry a large scale manufacturing of agarose beads with high porosity and rigidity. Production department facilitated as per ISO certified quality management system guidelines. They are maintaining ambient temperature and pressure limits to provide suitable consistency to the product, air control by using air handling units (AHU) [7]. In bio works, they are maintaining a class-B in the manufacturing area.  Installation of instrumentation is followed by the current validation and qualification parameters like design qualification (DQ), installation qualification (IQ), Operational Qualification(OQ), Process qualification(PQ)  [6]. Documentation maintained as per the good documentation practice guidelines (GDP) [8]. BioWorks is focusing on examining the impact on the length of the carbonic link which called the linker; this chain connects the agarose beads with the functional group. The length of this chain performs a crucial role in making the functional group available to protein molecules in ion-exchange chromatography which increases the effectiveness and productivity of the purification [7].

Here is the general method for the making of agarose beads. Agarose is a solid dissolved in distilled water that heated to about 90C. Next added to a stirred vessel that contains a hydrophobic solution to the emulsifier. Because of including an emulsifier, the solution is immiscible so the constant agitation forms of agarose droplets. The surfactant is added to prevent droplets. Next, the solution is cool about below the gelation point of agarose. The beads are then washed sieved through hydrophobic membranes to narrow the size distribution and cross-linking with a used reagent [6].

Conclusion

The company produces an agarose-based resin bead that provides the market with both, bulk resin or resin Prepacked in the column to be used in chromatography protein purification. The resin is unique since it is shortly cross-linked. Proteins and other molecules are isolated from the complex mixture by liquid chromatography. In this process, small beads of high rigid absorbers are properly packed into the columns. The beads are designed to bind molecules in a sample of the solution to various conditions.

References

• [1] Nicolas Ioannidis et al, Manufacturing Of Agarose-based Chromatographic media with controlled Pore and particle size published on 21 July 2017.
• [2] Mauryn C. Nwekw, et al. Mechanical characterization of agarose-based chromatography resins for biopharmaceutical manufacture published on 21 July 2017.
• [3]Good Manufacturing Practices and its guidelines.
• [4] Agarose characterization.
• [5] Bio-works. ISO certification and guidelines.
• [6] GMP guidelines.
• [7] General Method for making of Agarose beads.
• [8] Richard C. et al, the large scale of Protein Purification in 47907
• [9] Mauryn C. Nwekea, R. Graham McCartneyb, Daniel G. Brace well Etal, Mechanical characterization of agarose-based chromatography resins for biopharmaceutical manufacture published on 20 Nov 2017.
• [10] ISO Medical guidelines.