BD Bionutrients Technical Manual BD Biosciences – Advanced Bioprocessing
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BD Difco™ ™ BD BBL I-452-0160.tif 40 BD Bacto™ BD Bionutrients Technical Manual BD Biosciences – Advanced Bioprocessing Fourth Edition Your Cell Solutions Partner TABLE OF CONTENTS INTRODUCTION .......................................................................1 ANIMAL-ORIGIN PEPTONES .............................................30 Capability ...........................................................................1 Meat Peptones .................................................................30 History ................................................................................2 BD BBL™ Beef Extract Powder....................................30 Product Quality ..................................................................2 BD Bacto™ Beef Extract, Desiccated ...........................30 Service ................................................................................3 BD BBL™ Gelysate™ Peptone......................................32 BD Bacto™ Neopeptone .............................................33 HYDROLYSIS TO HYDROLYSATE .......................................4 BD Bacto™ Peptone ....................................................34 ™ ™ BD BBL Polypeptone Peptone ................................35 Protein Hydrolysis ..............................................................4 ™ BD Bacto Proteose Peptone .....................................36 Peptone Manufacture .........................................................5 ™ BD BiTek Proteose Peptone .....................................37 Ultrafiltration .....................................................................6 ™ BD Bacto Proteose Peptone, No.2 ............................37 ™ BD Bacto Proteose Peptone, No.3 ............................37 ™ CELL CULTURE APPLICATIONS ...........................................7 BD BiTek Proteose Peptone, No.3 ............................37 ™ Introduction .......................................................................7 BD Bacto Proteose Peptone, No.4 ............................37 ™ BD Bacto Tryptose ...................................................40 Base Medium Selection ......................................................8 Casein and Whey Peptones ..............................................44 Supplement and Feed Selection .........................................8 ™ ™ Process Optimization........................................................10 BD BBL Acidicase Peptone ....................................44 BD Bacto™ Casamino Acids........................................45 BD Bacto™ Casamino Acids, Technical ........................45 FERMENTATION APPLICATIONS ......................................14 BD BBL™ Biosate Peptone ..........................................46 Defined vs Complex Media ..............................................14 BD Difco™ Casein Digest ............................................47 Media Design ...................................................................14 BD Bacto™ Casitone ...................................................48 Selecting a Peptone ..........................................................15 BD BBL™ Trypticase™ Peptone ....................................48 Moving to Animal-Free Media Components .....................15 BD Bacto™ Tryptone ...................................................48 BD BiTek™ Tryptone ....................................................48 ANIMAL-FREE PEPTONES AND YEAST EXTRACTS ...17 BD Bacto™ TC Lactalbumin Hydrolysate .....................51 Soy Peptones ....................................................................17 CHEMICALLY DEFINED SUPPLEMENTS AND FEEDS ...54 Yeast Products ..................................................................17 Product Listings ................................................................18 Chemically Defined Supplements .....................................54 BD Bacto™ Malt Extract .............................................18 BD Recharge™ ..................................................................55 BD BBL™ Phytone™ Peptone ......................................19 BD Resurge™ ....................................................................56 BD Difco™ Select Phytone™ UF ..................................19 BD Difco™ Select Soytone ..........................................19 BD Bacto™ Soytone ....................................................20 BD Bacto™ TC Yeastolate ...........................................23 BD Difco™ TC Yeastolate, UF ......................................23 BD Bacto™ Yeast Extract ............................................25 BD BBL™ Yeast Extract ...............................................25 BD Bacto™ Yeast Extract, Technical ............................25 BD Difco™ Yeast Extract, UF .......................................25 bdbiosciences.com/advbio BD Biosciences – Advanced Bioprocessing i TABLE OF CONTENTS BIONUTRIENTS MEDIA .......................................................58 Mammalian Cell Culture Media .......................................58 BD Cell™ mAb Medium, Animal Component Free ......58 BD Cell™ mAb Medium, Quantum Yield .....................58 BD Select™ CHO .........................................................59 BD Select™ CD1000 Medium .....................................60 Microbial Fermentation ....................................................61 BD BBL™ Select APS LB Broth Base ............................61 BD Difco™ Select APS Super Broth .............................. 61 BD Bacto™ Tryptose Phosphate Broth ........................61 BD Difco™ M9 Minimal Salts, 5X ................................ 65 BD Difco™ Yeast Nitrogen Base ..................................66 BD Difco™ Yeast Nitrogen Base, w/o Amino Acids ......66 BD Difco™ Yeast Nitrogen Base w/ Amino Acids and Ammonium Sulfate .............................................66 PROTOCOLS AND DEFINITION OF METHODS ...........68 Supplement Titration and Blending Protocols ...................68 Adaptation Protocols .......................................................71 Definition of Methods ......................................................72 REGULATORY DOCUMENTATION ...................................73 Certificates of Analysis .....................................................73 Change Notification Program ...........................................73 Certificates of Suitability ..................................................73 PRODUCT LISTING ................................................................74 ii BD Bionutrients Technical Manual Fourth Edition INTRODUCTION Introduction The BD Bionutrients Technical Manual is an easy-to-use reference tool to provide guidance in the selection of BD products for use in cell culture and microbial fermentation production, from research and development to the final finished product. It is our commitment to innovation and product consistency that makes BD (Becton, Dickinson and Company) a strong global supplier and partner. Through BD Biosciences – Advanced Bioprocessing (BDAB), we offer a full line of cell culture media, supplements and feeds (bionutrients) for the biotechnology, biopharmaceutical, and animal and human vaccine markets. Our dedication to cell culture and fermentation media markets is exemplified in our wide range of capabilities: • Bioproduction Media and Supplements Manufacturing — As part of BD’s global network of manufacturing centers, BDAB is focused on the development and manufacture of bionutrients. Our full suite of manufacturing services is tailored to meet the needs of your production process—from rapid small-scale medium production to full-scale GMP medium manufacturing. In Sparks, Maryland, our manufacturing plant produces dehydrated culture media (DCM), animal-origin bionutrients, ingredients, stains, and other products for microbiology and cell culture. Our first-of-its-kind, animal-free, antibiotic-free (AF2)™ bionutrients manufacturing facility in Miami, Florida solidifies BD’s commitment to providing high-quality, high-performing animal-free products for the cell culture industry. BDAB bionutrient manufacturing capabilities offer flexibility and capacity without sacrificing quality. Keeping your needs in mind, we are able to customize our processes and testing to meet your requirements, all while adhering to stringent quality standards. • Full Line of Supplements and Feeds for the Biopharmaceutical Market — BDAB has been a pioneer and a trusted partner of leading biopharmaceutical companies around the world. As a result, our products are used in the manufacture of more than 110 animal and human health biopharmaceuticals on the market today. Our offering of animal-free, animal-origin, and chemically defined supplements and feeds are tailored to work in a variety of biopharmaceutical applications to help you achieve optimal production yields with consistent performance. bdbiosciences.com/advbio BD Biosciences – Advanced Bioprocessing 1 INTRODUCTION • Media Design Service — BDAB offers a full of range of services from the development of custom media and feed formulations to the optimization of existing media and feeds. Our experience, combined with our proven methodology and extensive analytical capabilities, allow us to provide customers medium that works with their unique specifications, on time, and within budget. To learn more about BDAB Media Design Services, contact your local BD associate. History Beginning in 1895, Difco Laboratories produced high-quality enzymes, dehydrated tissues, and glandular products to aid in the digestion process.