Biological aggregate
Biological Aggregates can be composed of sugars, proteins, nucleic acids or complex combinations of these substances, or May Be living entities such as cells and tissues. These are isolated from a variety of natural sources — plant, animal or microorganism. A Biological Aggregate is an extract, or a preparation or product, such as a [...], a vaccine, a phytochemical, an antitoxin, used medically as a diagnostic, preventive, mitigating, or therapeutic agent, or a dietary supplement taken orally that contains one or more ingredients that are intended to supplement one's diet and are not considered food.
About:
Capitalizing on Biological Aggregate knowledge may give rise to cheaper and faster way to [...] discovery. They can be directly evaluated for clinical efficacy first rather than being subjected to initial chemical isolation on the basis of available traditional knowledge and by using the principle of reverse pharmacology. Thus, it can be said that Biological Aggregates offer a holistic approach to complement a pure reductionism approach towards diseases. While the mechanism of most Biological Aggregates remain elusive, it appears that synergy among different elements can be an important part of their overall beneficial effects. There are however many challenges in working with Biological Aggregates. The technical issues are abundant for working with batch-to-batch quality consistency. As the endeavor is largely unprecedented, there is no ready protocol to follow. Standardization of working procedures proves to be another major challenge. There are three basic paradigms of Biological Aggregates. Entity-based views concentrate on the products and active ingredients, including chemical structures and the unique aspects imparted by their biological source/identity. Development based views concentrate on the manufacturing process, specifications, methods of characterization and quality control procedures. Market/commercial-based views concentrate on products as competing for similar/same indications, having similar names, or any other perceived similarities.
Comparison with Botanicals and Herbals:
Sl. No. |
Parameter |
Botanicals |
Herbals |
Biological Aggregates |
|---|---|---|---|---|
01 |
Source |
Plants |
Herbs |
Plants or animals or microorganisms |
02 |
Ecological Conditions (insect feeding, microbial infections) |
May have an impact on activity |
May have an impact on activity |
May or may not have an impact |
03 |
Environmental Conditions (light, temperature, soil, altitude) |
May have an impact on activity |
May have an impact on activity |
May or may not have an impact |
04 |
Contamination (heavy metals, agrochemicals) |
May contain heavy metals & agrochemicals which inhibits activity |
May contain heavy metals & agrochemicals which inhibits activity |
May or may not contain heavy metals & agrochemicals |
05 |
FDA approval process |
Approved as botanical [...] substances |
Approved as dietary supplements |
Can be approved as botanical drugs or dietary supplements or drugs |
Sources:
• Plant source: Biological Aggregates obtained from plant parts or products like seeds, stem, roots, leaves, flowers, resin and other parts. The sources are known to provide the following classes for [...] discovery processes:
- • Biological Aggregate for direct use as [...],
- • Biological Aggregate which may act as lead compounds for more potent compounds,
- • The novel Biological Aggregate which may be converted into [...] compounds,
- • Pure Biological Aggregates for use as marker compounds for standardization of crude plant material or extract.
• Animal source: Animals can sometimes be a source of Biological Aggregates. Traditional Biological Aggregates from animal sources include insulin, pituitary hormones, vitamins, antibiotics, some vaccines and immune serums.
• Microorganisms: The microorganisms produce a large variety of Biological Aggregates which mainly play a role as anti-microbial, anti-cancer and anti-diabetic agents.
Characteristics:
• A Biological Aggregate is derived from a living system such as a microorganisms, or plants or animals. Mostly these are very large, complex molecules or mixture of molecules.
• It is difficult, and sometimes impossible, to characterize a complex Biological Aggregate by testing methods available in the laboratory, and some of the components of a finished Biological Aggregate may be unknown.
• Adequate measures need to be taken to ensure product consistency, quality, and purity by standardizing the manufacturing process, as it is difficult to characterize Biological Aggregates.
• Process controls are established separately for each Biological Aggregate, and are not applicable to a manufacturing process/product created by another manufacturer.