BD Bionutrientsâ„¢ Technical Manual

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RFU RFU 6000 5000 4000 3000 2000 1000 0 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 0 Cell Culture Applications Figure 4 TC Yeastolate UF Titration CHO Line A in Complete Medium 1 0 1 3 5 7 9 11 13 15 17 Peptone Concentration (g/L) Figure 6 Phytone UF Titration CHO Line A in Complete Medium 1 0 1 3 5 7 9 11 13 15 17 Peptone Concentration (g/L) Process Optimization The improved performance obtained through the identification of a new base medium and peptone supplementation will be further enhanced when coupled with an effective feed strategy. 8 Using spent media analysis to understand the cell’s nutritional requirements makes it possible to design a peptone feed strategy that greatly enhances the process performance. In some cases a chemically defined feed may be utilized. However, in many situations a peptone based feed can result in substantial increases in cell proliferation and production. Determining how to apply the peptone is essential to achieving the increased performance. While some processes require that peptone is present from the beginning of the run, others perform best when the peptone is added as a feed later in the process (Figure 11). In some cases, optimal performance is achieved when the process begins with one peptone then another is added as a feed later in the production run (Figure 12). Having a thorough understanding of the production process is critical for maintaining consistent results. There are many potential sources of variability and each needs to be identified and controlled. Sources of variability include base media between manufacturers or lots, key components added at the beginning or as a feed supplement, and the use of generic manufacturing processes that are suboptimal for a particular cell line. Peptones are also cited as a RFU ng/mL RFU ng/mL 12000 10000 8000 6000 4000 2000 0 10000 9000 8000 7000 6000 5000 4000 3000 2000 1000 0 Antibody Yield (ng/mL) Antibody Yield (ng/mL) 0 1 3 5 7 9 11 13 15 17 12 BD BIONUTRIENTS TECHNICAL MANUAL RFU RFU 10000 9000 8000 7000 6000 5000 4000 3000 2000 1000 7000 6000 5000 4000 3000 2000 1000 0 0 Figure 5 Developmental Wheat UF Titration CHO Line A in Complete Medium 1 0 1 3 5 7 9 11 13 15 17 Peptone Concentration (g/L) Figure 7 Phytone UF Titration Hybridoma Line in Complete Medium 1 Peptone Concentration (g/L) RFU ng/mL RFU ng/mL 30000 25000 20000 15000 10000 5000 0 14000 12000 10000 8000 6000 4000 2000 0 Antibody Yield (ng/mL) Antibody Yield (ng/mL)
potential source of variability. Peptones designed for the biopharmaceutical industry are manufactured and released to strict specifications. In general, the variability that is observed when these peptones are used is the result of their use in a poorly understood biopharmaceutical production process. Through a comprehensive analysis of the spent media from multiple production runs using multiple peptone lots, key component concentrations can be identified and maintained at the appropriate levels. Once the process is properly controlled, the expected results will be consistently achieved. BD AutoNutrient Media Design Service (AMDS) Performing thorough optimizations can require significant time and resources, so the decision is often made to eliminate many potentially critical design points. By truncating the design, the desired production goal could be missed. To address this need and ensure the identification of the optimal media formulation that meets production goals, BD offers the AutoNutrient Media Design Service (AMDS). The BD team of dedicated, experienced scientists works with each customer in a highly collaborative process to develop a media formulation that satisfies the requirements. Through the AMDS program, BD offers a library of 45 diverse, chemically defined media, as well as a number of peptones designed specifically for the biopharmaceutical industry. Proprietary DOEs are used to optimize a base medium specifically for the cell line or RFU Antibody Yield (ng/mL) 10000 9000 8000 7000 6000 5000 4000 3000 2000 1000 0 80000 70000 60000 50000 40000 30000 20000 10000 0 Figure 8 Developmental Wheat UF Titration CHO Line A in Complete Medium 1 0 1 3 5 7 9 11 13 15 17 Peptone Concentration (g/L) Figure 10 Peptone Blend Comparison Study CHO Line A in Complete Medium 1 RFU ng/mL Blend 1 1 g/L TC Yeastolate UF No Peptone ADVANCED BIOPROCESSING • THIRD EDITION 0 Day 7 Day 10 30000 25000 20000 15000 10000 5000 Antibody Yield (ng/mL) RFU 4000 3500 3000 2500 2000 1500 1000 500 Antibody Yield (mg/L) 0 1400 1200 1000 800 600 400 200 Cell Culture Applications Figure 9 Developmental Wheat UF Titration CHO Line A in Complete Medium 2 RFU ng/mL 0 1 3 5 7 9 11 13 15 17 Peptone Concentration (g/L) Figure 11 Peptone Feed Study CHO Line B in Complete Medium 3 0 D0 and D3 Peptone Feed D0 Peptone Feed No Feed 4500 4000 3500 3000 2500 2000 1500 1000 500 0 Day 14 Antibody Yield (ng/mL) 13
Page 1: BD Bionutrients Technical Manual A
Page 4 and 5: Table of Contents Meat Peptones 30
Page 6 and 7: Introduction packaging and QC testi
Page 8 and 9: Introduction • BSE/TSE Risk Mitig
Page 10 and 11: Hydrolysis to Hydrolysate Hydrolysi
Page 12 and 13: Hydrolysis to Hydrolysate Figure 2
Page 14 and 15: Cell Culture Applications Figure 1
Page 18 and 19: Cell Culture Applications Antibody
Page 20 and 21: Average OD at 600 nm Average OD at
Page 22 and 23: Availability Animal Free Peptones a
Page 24 and 25: Area Percentage 70 60 50 40 30 20 1
Page 28 and 29: Area Percentage Area Percentage 70
Page 32 and 33: Product Name Animal Free Peptones a
Page 34 and 35: Meat Peptones Meat Peptones Meat pe
Page 40 and 41: RFU 10000 8000 6000 4000 2000 Meat
Page 46 and 47: Product Name Meat Peptones Total Ni
Page 48 and 49: Casein and Whey Peptones Casein and
Page 56 and 57: Casein and Whey Peptones Product Na
Page 58 and 59: BD Bionutrients Media BD Bionutrie
Page 60 and 61: IgG (µg/mL) BD Bionutrients Media
Page 62 and 63: BD Bionutrients Media BBL Select
Page 64 and 65: BD Bionutrients Media Average OD a
Page 66 and 67:
BD Bionutrients Media Difco M9 Mi
Page 68 and 69:
BD Bionutrients Media Yeast Nitrog
Page 70 and 71:
Exhibit 1 Regulatory Documentation
Page 72:
BD Biosciences 7 Loveton Circle Spa
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BD Bionutrientsâ„¢ Technical Manual

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