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What is API Contract Manufacturing? - DFDVX187 - 14-11-2022
What is API Contract Manufacturing?
Partnering with the right contractor is one of the most critical decisions a pharmaceutical company can make
The active pharmaceutical ingredient (API) is the foundation of a final drug product and is a crucial consideration when choosing a Contract Development and Manufacturing Organisation (CDMO). To understand API contract manufacturing, first, it is necessary to understand what is meant by an “active ingredient.”
Also called the “bulk active” or “bulk drug substance,” the API is the part of the drug that produces the intended effect in the diagnosis, cure, mitigation, treatment or prevention of disease or that affects the structure or any function of a human or animal. The term includes those components that may undergo a chemical change and be present in a modified form intended to furnish the specified pharmacological activity in a finished drug product.
An API is formulated with other components that don’t perform the intended chemistry or biochemistry in the body. These components are called “inactive ingredients.” Active and inactive ingredients are mixed in various dosage forms (such as tablets, capsules or liquids) to yield a drug product.
The manufacture of APIs is a complex, specialised activity, requiring the expert intertwining of chemistry, biology and engineering. For instance, APIs include substances manufactured by a range of processes, including chemical synthesis, fermentation, recombinant DNA or other biotechnology methods, isolation/recovery from natural sources or through any combination of these processes.
Within the pharmaceutical industry, the entire process of making a drug product is either carried out by the owner of the drug, or by engaging a third party or parties (i.e., CDMOs) to complete the whole manufacturing process, or one or more discrete operations, under contract.
Although some companies are hesitant to outsource because of concerns around data security and quality or issues relating to change management, most drug development companies have realized that the return on investment has been worthwhile and that with the right partner, the advantages outweigh the potential risks.
Outsourcing to CDMOs can also provide companies with access to a flexible workforce comprised of highly-specialized experts. Recently, increased outsourcing to CDMOs has been observed for drug owners from biopharma to pharma companies, from small to large firms, and for early to late-stage development projects.
The quality of APIs has a significant effect on the efficacy (producing the result desired) and the safety of medications. Choosing a CDMO that can provide the right API at the required strength, quality and purity is, therefore, a critical decision for drug development companies.
Favipiravir
Favipiravir (T-705, 6-fluoro-3-hydroxypyrazine-2-carboxamide) is a novel low molecular weight antiviral compound. It has shown activity against many types of RNA viruses (all strains of influenza А, В, С, arenovirus, bunyavirus, flavivirus, alphavirus, norovirus,as well as the Zika, Usutu,and Ebola viruses). The generally good tolerance of human patients to favipiravir and the high barrier to the development of resistant viral strains indicate that this drug holds great promise for clinical use around the world. It should be noted that a representative of the Zhejiang Hisun Pharmaceutical company from China has anounced that this company has received marketing authorization from the Chinese government for favipiravir as a possible medication against the coronavirus causing Covid-19.
Favipiravir was first synthesized in 2000 by a route consisting of seven steps. The starting material was 3-aminopyrazine-2-carboxylic acid. The amination step was catalyzed by a costly (S)-(–)-2,2'-bis(diphenylphosphino)-1,1'-binaphthyl ((S)-BINAP), fluorination required using the highly corrosive Olah reagent, while the overall reaction yield was approximately 0.44%.
Improved methodologies for the synthesis of favipiravir have been reported in recent years. In particular, a fourstep method enabled the synthesis of favipiravir from commercially available 3-hydroxypyrazine-2-carboxylic acid, which was subjected to esterification and amidation. The nitration of pyrazine ring was followed by reduction of the nitro group in the presence of Raney nickel, allowing to minimize the amount of byproducts. After the replacement of amino group with a fluorine atom, the overall yield of the target product 1 was 8%.
Edoxaban versus Warfarin in Patients with Atrial Fibrillation
Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known.
METHODS
We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding.
RESULTS
The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32).
Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391. opens in new tab.)
Nicotinamide riboside Chemical Properties,Uses,Production
Nicotinamide Riboside (NR) is a next-generation vitamin B3 that has been found to be naturally-occurring in milk in trace amounts. The metabolism of NR is unique from that of other more commonly known forms of vitamin B3 , nicotinamide and nicotinic acid. Specifically, NR has been shown in a pre-clinical study to be the most effective form of vitamin B3 at increasing nicotinamide adenine dinucleotide (NAD+)2 .
Nicotinic acid (also known as niacin) and nicotinamide (also known as niacinamide) were discovered in the 1930’s to be the factors that cured pellagra . Niacin is known to cause severe flushing . In 2004, nicotinamide riboside emerged as a newly discovered NAD+ precursor and does not bind to the receptor responsible for flushing.
NR has pre-clinically demonstrated that it is superior to both niacin and nicotinamide, both of which are standard forms of vitamin B3 commonly used in vitamin supplements and foods, at boosting NAD+2 . This is due to the fact that NR is not reliant upon a conversion step requiring the enzyme “NAMPT” , see Figure below. The activity level of NAMPT determines the amount of nicotinamide that is converted into NAD+ , which is why this particular step in the process is often referred to as the “rate limiting step”. As normal aging occurs, the activity of NAMPT is thought to decrease. NR can be used by the cell to make NAD+ without this enzymatic step.
Chemical Properties of Nicotinamide
Nicotinamide riboside (NR) is part of the B3 vitamin family. Like other forms of vitamin B3, nicotinamide riboside gets converted into nicotinamide adenine dinucleotide (NAD+), a coenzyme essential for life. For this reason, it is often called a NAD+ precursor because it is part of the series of chemical steps that are required to create NAD+.
Different biosynthetic pathways are responsible for converting the different B3 vitamins into NAD+. The enzyme nicotinamide phosphoribosyltransferase (Nampt) catalyzes the rate-limiting step of the two-step pathway converting nicotinamide to NAD+. NR kinase enzymes can also function as a salvage pathway for NAD+, but this pathway is not essential.
Uses
Nicotinamide Riboside can be used in biological study of gene circadian reprogramming transcriptome in liver identified metabolic pathways of aging in mouse. It also increases NAD+ in the cerebral cortex and reduces cognitive deterioration in a transgenic mouse model of Alzheimer’s disease.
Definition
ChEBI: A pyridine nucleoside consisting of nicotinamide with a beta-D-ribofuranosyl moiety at the 1-position.
benefits
Nicotinamide riboside (NR) is one of the viable natural precursors for the biosynthesis of NAD+ via two alternative pathways involving the purine nucleoside phosphorylase or the nicotinamide riboside kinase enzymes. Therapeutic benefits of nicotinamide riboside supplementation:
Constant dietary supplementation of nicotinamide riboside has been shown to increase the NAD+ levels in middle aged to elderly people.
It may support mitochondrial function.
It may enhance memory and combat cognitive decline.
It might lengthen your life.
It might promote muscle quality and strength.
It might counter the effects of a high-fat diet.
In 2016 NR received the GRAS (Generally Recognized As Safe) status from the FDA. NR also demonstrated the potential to slow aging processes in mice models.
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