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GMP-grade vaccineux extractants and unprocessed materials
Usually, inactive antigens from bacteria or viruses are included in vaccines. These antigens trigger an immunological response by activating the immune system. As a result, antibodies that are complementary to the target organism are produced, providing defense against it. In addition to inactivated viral or bacterial antigens, vaccines also contain excipients to improve their safety and effectiveness. Certain vaccine excipients, intermediates, and process solutions are removed from the final product during downstream vaccine processing, even though they are still required for the vaccine’s final formulation.
Vaccine manufacturing
The two fundamental categories into which vaccine manufacturing can be separated are downstream and upstream manufacturing. Controlled bacterial or viral growth is a component of upstream processes. The next stage of the downstream processing process is to gather and purify antigens before producing the final vaccine after acquiring the required pathogens. Before the final product is assessed for safety and efficacy, a variety of intermediates, process solutions, and vaccine excipients are used in the downstream process. Downstream processing is an important and complex process because it directly affects the safety, efficacy, and quality of the final vaccine product. All downstream processing intermediates, process solutions, and vaccine excipients must be prepared in strict accordance with GMP standards and pass stringent quality checks outlined by pertinent regulatory agencies in order to guarantee the safety and effectiveness of the finished products.
Learn additional details about our GMP-grade excipients. Different GMP-grade vaccine excipients are required for different uses in the following downstream vaccine manufacturing processes:
Inactivating agents:
Using inactivating chemicals, diseases' toxins can be rendered inactive, and bacteria and viruses can be weakened. Inactivating chemicals are needed to lower the pathogenicity of bacteria or viruses to a safe level. GMP classifications Among the vaccine excipients that are commonly used as inactivating agents are polysorbate 80 and formaldehyde. Once viruses or bacteria have been successfully inactivated, these compounds are removed before vaccine formulations are processed further.
Purification agents:
After bacteria or viruses have been rendered inactive, antigens must be extracted from the co-precipitated material. The acquisition of high yields of antigens for subsequent processing depends on this purification stage. Among the vaccine excipients utilized as purification agents are Benzalkonium Chloride and CTAB in GMP grades.
Buffers and process solutions:
Phosphate fluctuations during multi-stage vaccination manufacturing processes can degrade inactivated antigens, reducing their efficacy. In order to maintain the pH in the intended range and prevent pH fluctuations, buffers are used in media. GMP-grade potassium phosphate, sodium citrate, and sodium phosphate buffers are some of the commonly used buffers.
Stabilizers:
Vaccines are supplemented with vaccine excipients that function as stabilizing agents, such as GMP grade , to withstand environmental elements during storage, transit, and 2-PhenoxyethanolSucrose and urea.Vaccines are supplemented with vaccine excipients that function as stabilizing agents, such as GMP grade , to withstand environmental elements during storage, transit, and 2-PhenoxyethanolSucrose and urea.
Tonicity adjusters:
Vaccines must dissolve and distribute quickly after being administered, and they must be isotonic to body fluids. A number of salts, including GMP grades of Sodium Chloride and Calcium Chloride, are extensively used in vaccines to achieve required tonicity of vaccines matching bodily fluids, for optimum dosage delivery.
Preservatives:
Small quantities of preservatives are also added to the final vaccine to prevent bacterial and fungal contamination during storage and usage, particularly for multi-dose vials. Some of the approved preservatives include GMP grades of Thimerosal, Formaldehyde, Phenol, Benzalkonium Chloride and 2-Phenoxyethanol.
A&C has been providing services to the vaccine sector for a number of years. We provide vaccine manufacturers worldwide with a broad selection of GMP grade vaccine excipients, intermediates, and process solutions. Some of the top vaccine manufacturers in the world have developed and marketed a number of novel vaccines that contain our vaccine excipients.
We provide GMP custom development of niche and novel excipients , GMP custom manufacturin, GMP packaging and down packing of liquid and powder raw materials. A&C provides customized GMP solutions for raw materials and excipients, from formulation development in the early stages to supply on a commercial scale in the later stages.
The following is a list of the main vaccine excipients, buffers, process solutions, and raw materials that A&C offers to meet your needs for vaccine manufacturing.
| Sku | Cas | Product Name | Category | Description | Spec | SDC |
|---|---|---|---|---|---|---|
| P1820214 | 122-99-6 | 2-PHENOXYETHANOL MULTI-COMPENDIAL A&C GRADE | Stabilizer / Preservative | A&C’s 2-Phenoxyethanol is used as an excipient and meets USP-NF, EP and BP monographs. | ||
| P1820214 | 122-99-6 | 2-PHENOXYETHANOL MULTI-COMPENDIAL A&C GRADE | Stabilizer / Preservative | A&C’s 2-Phenoxyethanol multi-compendial is a preservative meeting USF-NF, EP and BP monographs. It is used as a preservative and cosmetic raw material. It is a bactericide and chemical preservative used in dermatological products like sunscreen and skin creams. 2-Phenoxyethanol is also used as a preservative in vaccines and various pharmaceuticals. | ||
| P1820224 | 122-99-6 | 2-PHENOXYETHANOL MULTI-COMPENDIAL API GRADE | Stabilizer / Preservative | A&C’s 2-Phenoxyethanol API multi-compendial is an active ingredient which meets current USP-NF, EP and BP specifications. It is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs. It is a broad spectrum anti-microbial agent with low toxicity and has been used as a preservative in pharmaceutical applications. | ||
| P182022 | 122-99-6 | 2-PHENOXYETHANOL PHEUR | Stabilizer / Preservative | A&C’s 2-Phenoxyethanol is used as an excipient and meets the EP monograph. | ||
| B1416 | 8001-54-5 | BENZALKONIUM CHLORIDE 17% USP NF | 17% USP NF Purification agent / Preservative | A&C’s Benzalkonium Chloride 17% is a preservative which meets the NF monograph. | ||
| B14155 | 8001-54-5 | BENZALKONIUM CHLORIDE 50% MULTI-COMPENDIAL | 50% MULTI-COMPENDIAL Purification agent / Preservative | A&C’s Benzalkonium Chloride (BKC) 50% is an effective biocide that meets current USP-NF and EP requirements. | ||
| B1415 | 8001-54-5 | BENZALKONIUM CHLORIDE 50% NF | BENZALKONIUM CHLORIDE 50% NF | A&C’s Benzalkonium Chloride 50% is a preservative which meets the NF monograph. It acts as a quaternary ammonium compound, which is applied as a disinfectant and as a preservative in ophthalmic topical solutions. It is widely used as a preservative in eye drops and in the pharmaceutical industry it is employed as an antimicrobial preservative, antiseptic, disinfectant, solubilizing agent, and wetting agent, burn sprays, skin and wound cleaning. | ||
| C246901 | 57-09-0 | CTAB | Purification agent | A&C’s USP-NF grade CTAB meets the requirements of the NF monograph. It acts as a quaternary ammonium compound. As an effective surfactant, it is widely used as an antigen purifying agent in downstream vaccine manufacturing process. | ||
| F151 | 50-00-0 | FORMALDEHYD | Inactivating agent | Inactivating agent | ||
| P1384 | 217182-78-0 | PHENOL LIQUEFIED 90% USP | Preservative | A&C’s Phenol Liquefied 90% is an Active Pharmaceutical Ingredient (API) that conforms to the current USP-NF monograph. It is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs. | ||
| P13840 | 217182-78-0 | PHENOL LIQUEFIED 90% USP STABILIZED | Preservative | A&C’s Phenol Liquefied 90% is an Active Pharmaceutical Ingredient (API) stabilised with 20 ppm Citric Acid USP. It conforms to the current USP-NF monograph, and is manufactured and distributed according to Health Canada's GMP guidance (GUI-0104) in line with ICH Q7 GMPs for APIs. | ||
| P252058 | 9005-65-6 | POLYSORBATE 80 A&C GRADE MULTI-COMPENDIAL | Inactivating agent | A&C’s Polysorbate 80 multi-compendial is an excipient which meets USP-NF, EP, BP and JP monographs. It is a solubilizing agent that is used in the pharmaceutical industry. Polysorbate 80 (also known as polyoxyethylene-sorbitan-20 mono-oleate) is used as an emulsifier, surfactant and solubilizing in soft gel formulations in the pharmaceutical industry in medical preparations (e.g., vitamin oils, vaccines, and intravenous preparations) and as an excipient in tablets. | ||
| P252060 | 9005-65-6 | POLYSORBATE 80 NF | Inactivating agent | A&C’s Polysorbate 80 is an excipient which meets the NF monograph. It is a solubilizing agent that is used in the pharmaceutical industry. Polysorbate 80 (also known as polyoxyethylene-sorbitan-20 mono-oleate) is used as an emulsifier, surfactant and solubilizing in soft gel formulations in the pharmaceutical industry in medical preparations (e.g., vitamin oils, vaccines, and intravenous preparations) and as an excipient in tablets. | ||
| P4674 | 7778-77-0 | POTASSIUM PHOSPHATE MONOBASIC | Buffer / Process solution | A&C’s Potassium phosphate monobasic multi-compendial is an excipient which meets the USP-NF, EP and BP monographs requirements. It is applied in buffering, which does not require an acidic product, pH adjuster in the manufacturer of finished pharmaceutical products. Potassium Phosphate Monobasic is commonly used as an element during the preparation of phosphate based buffers in pharmaceuticals. Potassium Phosphate buffers are very useful in numerous applications and they are used specifically for protein purification and bioprocessing. Potassium phosphate salts are highly water soluble and provide high-solution clarity. | ||
| P4673 | 7778-77-0 | POTASSIUM PHOSPHATE MONOBASIC NF | Buffer / Process solution | A&C’s Potassium phosphate monobasic multi-compendial is an excipient which meets the USP-NF, EP and BP monographs requirements. It is applied in buffering, which does not require an acidic product, pH adjuster in the manufacturer of finished pharmaceutical products. Potassium Phosphate Monobasic is commonly used as an element during the preparation of phosphate-based buffers in pharmaceuticals. Potassium Phosphate buffers are very useful in numerous applications and they are used specifically for protein purification and bioprocessing. Potassium phosphate salts are highly water soluble and provide high-solution clarity. | ||
| S2655 | 6132-04-3 | SODIUM CITRATE DIHYDRATE | Buffer / Process solution | A&C's Sodium Citrate Dihydrate multi-compendial is a trisodium salt of citric acid manufactured to meet the requirements of the EP, USP-NF and the FCC monographs. It is a white granular crystalline solid or powder, freely soluble in water and pleasantly salty. | ||
| S26660 | 6132-04-3 | SODIUM CITRATE DIHYDRATE | Buffer / Process solution | A&C's Sodium Citrate Dihydrate USP-NF is a trisodium salt of citric acid manufactured to meet all requirements of the USP-NF specifications. It is a white granular crystalline solid or powder, it is freely soluble in water and is pleasantly salty. | ||
| S266 | 6132-04-3 | SODIUM CITRATE DIHYDRATE | Buffer / Process solution | A&C's Sodium Citrate Dihydrate USP-NF is a trisodium salt of citric acid manufactured to meet all requirements of the USP-NF specifications. It is a white granular crystalline solid or powder, it is freely soluble in water and is pleasantly salty. | ||
| S38630 | 7782-85-6 | SODIUM PHOSPHATE DIBASIC 7-HYDRATE MULTICOMPENDIAL LOW ENDOTOXIN | Buffer / Process solution | A&C’s Sodium Phosphate Dibasic 7-H2O Multi-Compendial Low Endotoxin is an excipient which meets USP-NF, EP and BP monographs | ||
| S3860 | 7782-85-6 | SODIUM PHOSPHATE DIBASIC 7-HYDRATE US | Buffer / Process solution | A&C’s Sodium Phosphate Dibasic 7-Hydrate is an excipient which meets the USP monograph. | ||
| S3847 | 7558-79-4 | SODIUM PHOSPHATE DIBASIC ANHYDROUS MULTICOMPENDIAL LOW ENDOTOXIN | Buffer / Process solution | A&C's Sodium Phosphate Dibasic Anhydrous multi-compendial low endotoxin is an excipient which meets USP-NF, EP and BP monograph | ||
| S3845 | 7558-79-4 | SODIUM PHOSPHATE DIBASIC ANHYDROUS USP POWDER | Buffer / Process solution | A&C’s Sodium Phosphate Dibasic Anhydrous is an excipient which meets the USP monograph | ||
| S378 | 7558-80-7 | SODIUM PHOSPHATE MONOBASIC ANHYDROUS USP | Buffer / Process solution | A&C’s Sodium Phosphate Monobasic Anhydrous is an excipient, which meets the USP monograph. One or two molecules of water of anhydrous are included in the USP sodium phosphate monobasic anhydrous. Sodium phosphate monobasic anhydrous form consists of a white crystalline powder or granules. Sodium Phosphate Monobasic Anhydrous is employed in various applications which includes the purification of antibodies Its application is combined with Sodium Dibasic Phosphate during the preparation of biological buffers. | ||
| S37580 | 13472-35-0 | SODIUM PHOSPHATE MONOBASIC DIHYDRATE MULTI-COMPEND | Buffer / Process solution | A&C’s Sodium Phosphate Monobasic Dihydrate multi-compendial is an excipient which meets USP-NF, EP and BP monographs. The hydrated form of sodium phosphate monobasic dihydrate consists of odourless, colourless or white, slightly deliquescent crystals. | ||
| S37570 | 13472-35-0 | SODIUM PHOSPHATE MONOBASIC DIHYDRATE USP (B) | Buffer / Process solution | A&C’s Sodium Phosphate Monobasic Dihydrate is an excipient which meets the USP monograph. The hydrated form of sodium phosphate monobasic dihydrate consists of odourless, colourless or white, slightly deliquescent crystals. | ||
| S37553 | 10049-21-5 | SODIUM PHOSPHATE MONOBASIC MONOHYDRATE CRYSTAL USP | Buffer / Process solution | A&C’s Sodium Phosphate Monobasic Monohydrate is an excipient which meets the USP monograph. | ||
| S375522 | 10049-21-5 | SODIUM PHOSPHATE MONOBASIC MONOHYDRATE MULTI-COMP | Buffer / Process solution | A&C’s Sodium Phosphate Monobasic Monohydrate multi-compendial is an excipient which meets USF-NF and BP monographs | ||
| S46835 | 57-50-1 | SUCROSE | Stabilizer | A&C's Sucrose multi-compendial is a pharmaceutical excipient grade meeting the current specifications of USP-NF, EP and JP monographs. It is a crystalline granular sugar. | ||
| T10229 | 54-64-8 | THIMEROSAL USP | Preservative | A&C’s Thimerosal USP is a preservative which meets the USP-NF monographs. It presents as a white to off-white crystalline powder. It is applied in many medical applications of skin test antigens, drug preservatives, antivenins, and ophthalmic and nasal products. It is employed as a preservative in vaccines and antibiotics. | ||
| T102291 | 54-64-8 | THIMEROSAL USP 10% (W/V) AQUEOUS SOLUTION | Preservative | A&C’s Thimerosal USP 10% aqueous solution is a preservative that meets the USP monograph. Thiomersal's main use is as an antiseptic and antifungal agent. In multidose injectable drugs, it prevents serious adverse effects such as the Staphylococcus infection | ||
| U1035 | 57-13-6 | UREA MULTI-COMPENDIAL | Stabilizer | A&C’s Multi-Compendial Urea meets USP-NF, EP, BP and JP monographs. It is one of the vaccine excipients used to improve stability of vaccine formulations |