GMP GRADE VACCINE EXCIPIENTS AND RAW MATERIALSs

Vaccines typically contain inactivated viruses or bacteria antigens which stimulate the inherent immune system, triggering an immune response. As a result, corresponding antibodies are produced which provide immunity from the actual pathogen for which the vaccine is designed. In addition to inactivated viruses or bacteria antigens, vaccines also contain some excipients aimed at increasing their efficacy and safety. Some vaccine excipients, intermediates and process solutions used in downstream vaccine processing are removed from the final vaccine, whereas the rest are essential ingredients for the final formulation.

 

Vaccine manufacturing can be broadly classified into two parts: upstream and downstream manufacturing. Upstream process involves growing virus or bacteria under controlled conditions. When the required pathogens are obtained, downstream processing begins with harvesting and purifying antigens, followed by formulating the final vaccine product. Downstream process utilizes several intermediates, process solutions and vaccine excipients before the final product is tested for safety and efficacy. Downstream processing is complex and critical, as it directly affects the quality, efficacy and safety of the final vaccine product. All downstream processing intermediates, process solutions and vaccine excipients are required to be manufactured under full GMP compliance to pass stringent quality checks laid out by relevant regulatory bodies, to ensure safety and efficacy of the final products.

 

Downstream vaccine manufacturing processes require different GMP grade vaccine excipients for specific purposes as described below:

  • Inactivating agents: Inactivating agents are used to attenuate viruses and bacteria or to inactivate disease toxins. Inactivating agents are essential to reduce pathogenicity of viruses or bacteria to safe levels. Some of the vaccine excipients widely used as inactivating agents include GMP grade Polysorbate 80 and GMP grade Formaldehyde. After successful inactivation of viruses or bacteria, these agents are removed before further processing of vaccine formulations.
  • Purification agents: Following deactivation of viruses or bacteria, antigens are required to be separated from the co-precipitated material. This purification step is crucial in obtaining high yields of antigens for further processing. Some of vaccine excipients used as purification agents include GMP grades of CTAB and Benzalkonium Chloride.
  • Buffers and process solutions: pH changes during multi-stage vaccine manufacturing processes can degrade inactivated antigens and thus reduce their efficacy. To maintain pH of media within the required window, buffers are employed to resist change in pH. Some of the widely used buffers are GMP grades of Sodium Phosphate, Potassium Phosphate and Sodium Citrate buffers.
  •  Stabilizers: To withstand environmental elements during storage, transport and handling, vaccines are added with vaccine excipients that work as stabilizing agents, such as GMP grade 2-Phenoxyethanol, Sucrose and Urea.
  • Tonicity adjusters: For rapid dissolution and distribution after administration, vaccines are required to be isotonic to bodily 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 servicing the vaccine industry for several years. We supply a wide range of GMP grade vaccine excipients, intermediates and process solutions to vaccine manufacturers around the world. Our vaccine excipients are used in a number of novel vaccines developed and marketed by some of the world’s leading vaccine manufacturers.

We provide GMP custom development of niche and novel excipients ,  GMP custom manufacturin, GMP packaging and down packing of liquid and powder raw materials. At A&C, we offer tailor-made GMP solutions for excipients and raw materials, from early-stage formulation development to late-stage commercial scale supply.

 

Below is a list of the main vaccine excipients, raw materials, buffers and process solutions that A&C offers for your vaccine manufacturing needs.

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