Cell Culture Solutions

40 products found for Cell Culture Solutions in Pharmaceuticals & Nutraceuticals
Roquette Dextrose Anhydrous Biopharma product card banner

Roquette

Roquette Dextrose Anhydrous Biopharma

Applications: Other Pharmaceutical Manufacturing Applications

Product Families: Cell Culture Solutions

Dextrose Anhydrous BioPharma from Roquette is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins. Roquette's in-process quality controls ensure a consistent supply of raw materials and excipients to help bring your biologics to life. Through our integrated supply chain and rigorous quality systems, we reduce the risks associated in biopharmaceutical manufacturing. Dextrose Anhydrous BioPharma is a multi-compendial material - USP, EP, JP. We are ready to help you with your upstream application needs for cell culture ingredients.

Biospectra Tris Excipient Multi Lble Tr3255 product card banner

Biospectra

Biospectra Tris Excipient Multi LBLE TR3255

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product

Biospectra Guanidine Hydrochloride 6M Bio Pharma Gh4120 product card banner

Biospectra

Biospectra Guanidine Hydrochloride 6M Bio Pharma GH4120

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Other Excipients

Guanidine Hydrochloride 6M solution can be used to denature proteins which become randomly coiled with no residual structure. This concentration is also used to decrease enzyme activity. The denatured proteins can be modified or analyzed using mass spectrometry, electrophoresis and enzymatic digests. As a chaotropic agent, Guanidine Hydrochloride solution is also used to break the hydrogen bonds in the structure of proteins and increase the solubility of hydrophobic molecules. The manufacturing of Guanidine Hydrochloride GH4120 is performed at BioSpectra’s Stroudsburg, PA facility utilizing dedicated equipment. Equipment used in the manufacturing of GH4120 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. Guanidine Hydrochloride 6M is a clear colorless solution. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra L-cystine Dihydrochloride Bio Pharma Cy4250 product card banner

Biospectra

Biospectra L-Cystine Dihydrochloride Bio Pharma CY4250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

L-Cystine is a dimer of two Cysteine residues and is a non-essential amino acid. It is synthesized from non-animal derived raw materials under appropriate controls for use in Pharm and Bio-Pharm production under a fully validated GMP manufacturing system. It is also suitable for cell culture media component for the commercial biomanufacturer of therapeutic recombinant proteins and monoclonal antibodies. The manufacturing of L-Cystine dihydrochloride CY4250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of L-Cystine dihydrochloride is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. L-Cystine dihydrochloride is a White to Pale Yellow Crystalline Powder.

Biospectra Sodium Hydroxide Solution 10N Gmp Pharma Nh4150 (Low Chloride) product card banner

Biospectra

Biospectra Sodium Hydroxide Solution 10N GMP Pharma NH4150 (Low Chloride)

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

High Purity Sodium Hydroxide (NaOH) 10N 30% is intended for use in critical Pharmaceutical process both upstream and downstream. This product is manufactured utilizing a proprietary, fully dedicated, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets. The manufacturing of Bio Pharma Grade Sodium Hydroxide NH4150 is performed at BioSpectra’s Bangor, PA, USA FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment Sodium Hydroxide is a Clear / Colorless Liquid.

Biospectra Sodium Decanoate Excipient Nd3220 product card banner

Biospectra

Biospectra Sodium Decanoate Excipient ND3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

Sodium Decanoate, or sodium caprate, is the sodium salt of caproic acid, a 10-carbon saturated fatty acid. It has amphiphilic character and can form micelles and liquid crystalline phases in aqueous solution. Sodium decanoate’s properties may help elucidate the transport of biologically active molecules and as a final component of a finished drug product, it may serve to enhance the bioavailability of the API. BioSpectra’s Bio Excipient Grade of Sodium Decanoate is supported by a Type IV drug master file submitted with the FDA. The manufacturing of Sodium Decanoate ND3220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Sodium Decanoate is a White to off-white powder.

Biospectra Tris Excipient Tr3220 product card banner

Biospectra

Biospectra Tris Excipient TR3220

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tris, commonly used as a buffer in biochemistry and molecular biology, stabilizes the pH of solutions in electrophoresis and other biological applications. It is also an enzyme inhibitor used in the biopharmaceutical industry and is commonly utilized in electrochromatography, UV analysis and HPLC applications. Tris is extensively used as a biological buffer or a component of buffer solutions. Tris can be used as a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product.

Biospectra Tris Gmp Bio Pharma Tr4220 product card banner

Biospectra

Biospectra Tris GMP Bio Pharma TR4220

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

TRIS or Tromethamine, commonly used as a buffer in biochemistry and molecular biology, stabilizes the pH of solutions in electrophoresis and other biological applications. It is also an enzyme inhibitor used in the biopharmaceutical industry and is commonly utilized in electrochromatography, UV analysis and HPLC applications. TRIS is extensively used as a biological buffer or a component of buffer solutions. TRIS can be used as a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR4220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product.

Biospectra Tris Excipient Lble Standard Tr3254 product card banner

Biospectra

Biospectra Tris Excipient LBLE Standard TR3254

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3254 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Hepes Free Acid Excipient He3220 product card banner

Biospectra

Biospectra HEPES Free Acid Excipient HE3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

HEPES is a zwitterionic buffer used to maintain pH of media used in cell cultures. It is one of Good’s twelve buffers that has a pKa value similar to its pH value making it an ideal buffer for pH maintenance. It has only one restriction, it interferes with the Folin protein assay. This buffer can form radicals so it is not suitable for redox studies. HEPES is used as a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of HEPES HE3220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HE3220 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. HEPES is a White Crystalline Product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Tris Hcl Buffer Gmp Bio Pharma Th4220 product card banner

Biospectra

Biospectra Tris HCl Buffer GMP Bio Pharma TH4220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions. BioSpectra manufactures Tris Hydrochloride TH4220 in its Stroudsburg, PA facility. Tris Hydrochloride is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Mops Free Acid Excipient Mp3220 product card banner

Biospectra

Biospectra MOPS Free Acid Excipient MP3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

MOPS is a zwitterionic buffer used as a running buffer for denaturing gel electrophoresis and as a buffering agent in many biological and biochemical applications. MOPS interferes with the Folin protein assay and partially decomposes when autoclaved in the presence of glucose. MOPS can be used as a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The Manufacturing of MOPS MP3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. MOPS is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Guanidine Hydrochloride Excipient Gh3220 product card banner

Biospectra

Biospectra Guanidine Hydrochloride Excipient GH3220

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Other Excipients

Guanidine Hydrochloride is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic agent, it breaks down the structure of proteins. Guanidine Hydrochloride is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride decreases enzyme activity. It is also used to increase the solubility of hydrophobic molecules. The manufacturing of Guanidine Hydrochloride GH3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Tris Excipient Bet-cp Tr3251 product card banner

Biospectra

Biospectra Tris Excipient BET-CP TR3251

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3251 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Tris Lble Api Active Tr2250 product card banner

Biospectra

Biospectra Tris LBLE API Active TR2250

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions. The manufacturing of Tris Hydrochloride TH3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tris HCl is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Mes Monohydrate Excipient Me3220 product card banner

Biospectra

Biospectra MES Monohydrate Excipient ME3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

MES Monohydrate is a zwitterionic buffer that is not absorbed through cell membranes and is virtually transparent in UV light. MES is a buffering agent used in many biological and biochemical applications. It is also used as a running buffer for denaturing gel electrophoresis. The characteristics of low UV absorptivity, minimal reactivity, stable pH and solubility in water allow MES Monohydrate Excipient to be used as a Good’s buffer. The manufacturing of Bio Excipient Grade MES, Monohydrate ME3220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Excipient Grade MES, Monohydrate is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.

Biospectra Tris Hcl Excipient Th3220 product card banner

Biospectra

Biospectra Tris HCl Excipient TH3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions. The manufacturing of Tris Hydrochloride TH3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tris HCl is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Mops Free Acid Gmp Bio Pharma Mp4220 product card banner

Biospectra

Biospectra MOPS Free Acid GMP Bio Pharma MP4220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

MOPS is a zwitterionic buffer used as a running buffer for denaturing gel electrophoresis and as a buffering agent in many biological and biochemical applications. MOPS interferes with the Folin protein assay and partially decomposes when autoclaved in the presence of glucose. MOPS can be used as a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Bio Pharma Grade MOPS MP4220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. MOPS is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Guanidine Hydrochloride Gmp Bio Pharma Gh4220 product card banner

Biospectra

Biospectra Guanidine Hydrochloride GMP Bio Pharma GH4220

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Other Excipients

Guanidine Hydrochloride is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic agent, it breaks down the structure of proteins. Guanidine Hydrochloride is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride decreases enzyme activity. It is also used to increase the solubility of hydrophobic molecules. The manufacturing of Bio Pharma Grade Guanidine Hydrochloride GH4220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Guanidine HCl is a White Crystalline product.

Biospectra Guanidine Thiocyanate Excipient Gt3220 product card banner

Biospectra

Biospectra Guanidine Thiocyanate Excipient GT3220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Other Excipients

Guanidine Thiocyanate is a chaotropic agent. As one of the strongest protein denaturants, it inactivates nucleases more than twice as fast as Guanidine Hydrochloride. Guanidine Thiocyanate is preferred for the purification of RNA because it dissociates the RNA into its nucleic acids and protein forms. Higher molarity solutions of Guanidine Thiocyanate irreversibly inactivate RNase. Guanidine Thiocyanate causes proteins to dissolve readily, thus disintegrating cellular structures. BioSpectra manufactures Bio Excipient Grade Guanidine Thiocyanate GT3220 in its Bangor, PA facility. Guanidine Thiocyanate is packaged, stored, tested, and released at BioSpectra’s Bangor, PA facility. Guanidine Thiocyanate is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Trehalose Dihydrate Excipient Lble Te3250 product card banner

Biospectra

Biospectra Trehalose Dihydrate Excipient LBLE TE3250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Emulsifiers & Stabilizers

Trehalose Dihydrate is a non-reducing disaccharide used as an excipient in biotherapeutic applications. Its primary purpose is to protect the protein drug substance both in the liquid and frozen state. It provides tonicity, stabilization, cryo-protection and lyo-protection. Trehalose is superior to other sugars due to the rigidity of the alpha 1,1 bond. Trehalose is also more stable under high temperature and acidic conditions. Due to its non-reducing end, Trehalose does not react with other excipients such as amino acids or aldehydes. The Manufacturing of Trehalose, Dihydrate TE3250 is performed at BioSpectra’s Bangor, PA facility.

Biospectra Tris Hcl Excipient Lble Th3250 product card banner

Biospectra

Biospectra Tris HCl Excipient LBLE TH3250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions. The manufacturing of Tris Hydrochloride TH3250 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tris Hydrochloride is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Hepes Free Acid Excipient Lble He3250 product card banner

Biospectra

Biospectra HEPES Free Acid Excipient LBLE HE3250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

HEPES is a zwitterionic buffer used to maintain pH of media used in cell cultures. It is one of Good’s twelve buffers that has a pKa value similar to its pH value making it an ideal buffer for pH maintenance. It has only one restriction, it interferes with the Folin protein assay. This buffer can form radicals so it is not suitable for redox studies. HEPES is used as a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of HEPES HE3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of HE3250 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. HEPES is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. BioSpectra certifies that all HEPES HE4220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.

Biospectra Mes Monohydrate Gmp Bio Pharma Me4220 product card banner

Biospectra

Biospectra MES Monohydrate GMP Bio Pharma ME4220

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

MES Monohydrate is a zwitterionic buffer that is not absorbed through cell membranes and is virtually transparent in UV light. MES is a buffering agent used in many biological and biochemical applications. It is also used as a running buffer for denaturing gel electrophoresis. The characteristics of low UV absorptivity, minimal reactivity, stable pH and solubility in water allow MES Monohydrate to be used as a Good’s buffer. The manufacturing of Bio Pharma Grade MES, Monohydrate ME4220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Pharma Grade MES, Monohydrate is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. MES is a White Crystalline product.There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. BioSpectra certifies that all MES, Monohydrate ME4220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.MES, Monohydrate manufactured at BioSpectra and any raw materials used in the manufacture of MES, Monohydrate at BioSpectra are not subject to genetic modification.

Biospectra Guanidine Hydrochloride 6M Excipient Solution Gh3101 product card banner

Biospectra

Biospectra Guanidine Hydrochloride 6M Excipient Solution GH3101

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Other Excipients

Guanidine Hydrochloride 6M solution can be used to denature proteins which become randomly coiled with no residual structure. This concentration is also used to decrease enzyme activity. The denatured proteins can be modified or analyzed using mass spectrometry, electrophoresis and enzymatic digests. As a chaotropic agent, Guanidine Hydrochloride solution is also used to break the hydrogen bonds in the structure of proteins and increase the solubility of hydrophobic molecules. The manufacturing of Bio Excipient Grade Guanidine Hydrochloride 6M, GH3101 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Equipment used in the manufacturing of GH3101 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan. Guanidine Hydrochloride 6M is a clear colorless solution. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. BioSpectra certifies that all Guanidine Hydrochloride 6M, GH3101 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.

Biospectra D-galactose Milk Lble Gm3250 product card banner

Biospectra

Biospectra D-Galactose Milk LBLE GM3250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

D-Galactose, Milk derived is intended for use upstream and downstream in biological drug manufacturing process. For this purpose BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. The Manufacturing of D-Galactose, Milk Derived GM3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. D-Galactose, Milk Derived is a White to almost white crystalline powder. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. D-Galactose, Milk Derived at BioSpectra are not subject to genetic modification.

Biospectra D-galactose Plant Lble Ga3250 product card banner

Biospectra

Biospectra D-Galactose Plant LBLE GA3250

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

D-Galactose, plant derived is intended for use upstream and downstream in biological drug manufacturing process. For this purpose BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. The Manufacturing of D-Galactose, Plant Derived GA3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. D-Galactose, Plant Derived is a White to almost white crystalline powder. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. BioSpectra certifies that all D-Galactose, Plant Derived GA3250 manufactured at BioSpectra, and its raw materials, are not derived from or come in contact with animal parts, products, and/or byproducts. D-Galactose, Plant Derived manufactured at BioSpectra and any raw materials used in the manufacture of D-Galactose, Plant Derived at BioSpectra are not subject to genetic modification.

Biospectra D-galactose Plant Lble Lei Ga3251 product card banner

Biospectra

Biospectra D-Galactose Plant LBLE LEI GA3251

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

D-Galactose, Plant Derived is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose, BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. The Manufacturing of D-Galactose, Plant Derived GA3251 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. D-Galactose, Plant Derived is a White to almost white crystalline powder. BioSpectra certifies that all D-Galactose, Plant Derived GA3251 manufactured at BioSpectra and its raw materials are allergen free.

Biospectra Tris Excipient Multi-compendial Lble Tr3255 product card banner

Biospectra

Biospectra Tris Excipient Multi-Compendial LBLE TR3255

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product

Biospectra Tris Excipient Free Flowing Tr3252 product card banner

Biospectra

Biospectra Tris Excipient Free Flowing TR3252

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3252 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product. There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

Biospectra Tris Excipient Free-flowing Tr3252 product card banner

Biospectra

Biospectra Tris Excipient Free-Flowing TR3252

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water. The manufacturing of Tromethamine TR3252 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Tromethamine is a White Crystalline product

Biospectra D-galactose Plant Lble-lei Ga3251 product card banner

Biospectra

Biospectra D-Galactose Plant LBLE-LEI GA3251

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients

D-Galactose, Plant Derived is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose, BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. The Manufacturing of D-Galactose, Plant Derived GA3251 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. D-Galactose, Plant Derived is a White to almost white crystalline powder. BioSpectra certifies that all D-Galactose, Plant Derived GA3251 manufactured at BioSpectra and its raw materials are allergen free.

Biospectra Sucrose Excipient Beet Lble Sb3250 product card banner

Biospectra

Biospectra Sucrose Excipient Beet LBLE SB3250

Applications: Parenteral, Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Emulsifiers & Stabilizers

Sucrose Excipient LBLE is a non-reducing disaccharide used as an excipient in biotherapeutic applications. Its primary purpose is to protect the protein drug substance both in the liquid and frozen state. It provides tonicity, stabilization, cryo-protection and lyo-protection. Sucrose can be used as a supplement for bacterial culture media and starting agent in alcohol fermentation. BioSpectra’s brand of LBLE Excipient Grade Sucrose is manufactured specifically for use as a parenteral drug ingredient. The manufacturing of Sucrose SB3250 is performed at BioSpectra’s Bangor, PA facility and utilizes multiuse equipment. Equipment used in the manufacturing of Sucrose Bio Excipient grade is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan. Sucrose is a White to off-white crystalline product .

Cyclolab (2-Hydroxypropyl)-gamma-cyclodextrin product card banner

Cyclolab

Cyclolab (2-Hydroxypropyl)-gamma-cyclodextrin

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Emulsifiers & Stabilizers

Chemical Family: Cyclodextrins

(2-Hydroxypropyl)-γ-cyclodextrin is a gamma cyclodextrin that is a derivative of an 8-membered sugar ring molecule. (2-Hydroxypropyl)-γ-cyclodextrin can crosslink to form longer polymers. This overall is a very useful chemical for supramolecular chemistry. (2-Hydroxypropyl)-γ-cyclodextrin is also used in the solubilization of macromolecules and in cell culture applications. (2-Hydroxypropyl)-γ-cyclodextrin is similar to β-Cyclodextrin (sc-204430), but (2-Hydroxypropyl)-γ-cyclodextrin can work with larger molecules

Biospectra Sodium Hydroxide Solution 0.5N Gmp Pharma Nh4152 product card banner

Biospectra

Biospectra Sodium Hydroxide Solution 0.5N GMP Pharma NH4152

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Low Chloride, Low Iron, Low Endotoxin Made with USP Water for Injection (WFI). High Purity Sodium Hydroxide 0.5N solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, fully dedicated, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.

Biospectra Sodium Hydroxide Solution 0.1N Gmp Pharma Nh4154 product card banner

Biospectra

Biospectra Sodium Hydroxide Solution 0.1N GMP Pharma NH4154

Applications: Pharmaceutical Processing

Product Families: Cell Culture Solutions, Bioexcipients, Formulation & Processing Aids

Low Chloride, Low Iron, Low Endotoxin Made with USP Water for Injection (WFI). High Purity Sodium Hydroxide 0.1N solution is intended for use in critical pharmaceutical processes, both upstream and downstream. This product is manufactured utilizing a proprietary, fully dedicated, validated GMP system that utilizes multiple manufacturing and purification steps to achieve high purity results without the use of pellets.