Introduction of RW Single-use Bioreactor Bag

Rocking motion single-use bioreactor bag has been proven to have good oxygen transfer and mixing effects, in the applications of biopharmaceutical fields such as CGT, antibody, and vaccine production. RW single use bioreactor bag can improve application flexibility while providing sterile assurance.

Developed and manufactured based on the product concept of "quality comes from design", Lifecask RW single use bioreactor bags have good cell compatibility, bag strength, and reliability of key quality parameters, here are the advantages: 

The Excellent Performance of the Body Film Material

The Lifecask RW single-use bioreactor bag adopts the Lifemeta KA film independently developed by Cobetter for cell culture as the main body film (see Figure 1 for details). The following is the detailed data of the self-developed film material.

As shown in Table 1 and Figure 2, compared with the E&L data of common competitors’ films , the total extractable amount of Lifemeta KA film material for Lifecask RW single-use bioreactor bag is significantly lower, and the types of antioxidants and their derivatives are also lower than competitors’ products. At the same time, bDtBPP was not detected in the Cobetter Lifemeta KA film, and it has excellent tensile strength (as shown in Figure 2). All data indicate that the film material quality of Cobetter bioreactor bag products is trustworthy and reliable.

Table 1.  E&L comparison data
Brand	E&L Total extraction number of solvents (ug/cm2)	Antioxidant and its derivative species (Number)	bDtBPP Max extraction amount (ug/cm2)
Brand A	2.1065	11	0.1168
Brand B	1.394	5	0.3112
Brand C	13.2862	14	7.3511
Brand D	1.6993	5	-
Brand E	8.8873	18	1.7994
	3.4587	5	2.7889
Cobetter Lifemeta KA	0.7431	0	-

Figure2. Comparison of Tensile Strength of Film Materials

As shown in Table 2 and Figure 3, the validation results of film and cell co-culture and perfusion bag N-1 cell culture indicate that the Lifecask RW bioreactor bag has no overall cytotoxicity, no inhibitory effect on cell growth, and better cell compatibility.

Table 2. Comparison data of mainstream film materials E&L
Sample	Cell Density					Survive Rate
	0	48h	72h	96h	0	48h	72h	96h
blank-1	0.52	1.62	2.96	4.52	100	95	98	93
Brand X-1	0.51	1.28	2.51	3.49	94	91	95	90
Lifemeta KA-1	0.46	1.78	2.06	3.98	100	90	90	94
blank-2	1.95	4.74	8.84	23.4	90	95	97	98
Brand X-2	1.95	3.49	10.1	20.8	96	98	97	98
Lifemeta KA-2	1.66	4.8	12.1	24.9	91	95	98	98

Figure 3. 20L Infusion Bag N-1 Cell Culture Case

Multiple Processes and Application Choices

There are multiple specifications available for Lifecask RW bioreactor bags, with volumes ranging from 2L to 50L. Each volume of bioreactor bag comes with Basic, Pro, and Infusion standard configurations (refer to Table 3). Cobetter can also customize according to user needs, such as adjusting tubing configuration, intercepting membrane area or pore size, etc. In addition to self-produced main film materials, the self-produced portion of accessories required for the bag body also exceeds 90%. Therefore, Lifecask RW series products from Cobetter have an advantage in supply stability and can meet the growing demand for biopharmaceutical process applications. At present, our supply period is stable at 2-3 weeks, and we have sufficient stock for products and components with high frequency usage.

Table 3. Lifecash RW Bioreactor Bag Product Information
Bag size（L）	2	10	20	50
Suspension cell culture bag
Basic, Pro (with pH, DO electrode), Perfusion ( with pH、DO electrode, Retention membrane)
Operation size（L）	0.2-1	0.5-5	1-10	5-25
Adhesive cell culture bag (sheet-like carrier)
Operation size（L）	1	5	10	25
Carrier amount（g）	30	150	300	750

Note: Carrier addition amount 30g/L 

Strict Quality Management System

Cobetter adopts internationally-recognized quality management system and strictly controls all aspects of production, including product processing condition optimization, contamination, bag integrity and conducts multiple tests. At the same time, based on Cobetter’s fully-equipped and reliable analysis and testing capabilities, we conduct specification parameter testing on each batch of the pH and DO membranes to ensure the process reliability of each bioreactor bag at the user's site.

The production process of Lifecask RW bioreactor bags strictly follows the IS09001-2015 quality management system, ensuring that each batch of products is accompanied by material qualification certificates and batch traceability, and ensuring quality stability to the greatest extent possible. Cobetter can also provide users with comprehensive product validation and quality assurance documents, including validation guide, dissolved substances, MSDS, CoA, and non-animal origin statement, to safeguard the biopharmaceutical products.