Biological products are a subset of drugs; therefore both are regulated under provisions of the FDC Act.  However, only biological products are licensed under section 351 of the PHS Act.

Following initial laboratory and animal testing that show that investigational use in humans is reasonably safe, biological products (like other drugs), can be studied in clinical trials in humans under an investigational new drug application (IND) in accordance with the regulations at 21 CFR 312.  If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted as part of a marketing application.  Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for biological products subject to licensure under the PHS Act.  FDA approval to market a biologic is granted by issuance of a biologics license.
Biological products, like other drugs, are used for the treatment, prevention or cure of disease in humans. In contrast to chemically synthesized small molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biological products are generally derived from living material (e.g. human, animal, or microorganism) which are complex in structure, and thus are usually not fully characterized. 

The categories of therapeutic biological products currently regulated include the following:

Monoclonal antibodies for in vivo use;

Most proteins intended for therapeutic use, including cytokines, enzymes, and other novel proteins, except for vaccines;

Immunomodulators (non-vaccine and non-allergenic products);

Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo. 

Issuance of a biologics license is a determination that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity and potency of the product.  Among other things, safety and purity assessments must consider the storage and testing of cell substrates that are often used to manufacture biologics.

As mentioned above, biologics are subject to provisions of both the FD&C Act and the PHS Act.  Because of the complexity of manufacturing and characterizing a biologic, the PHS Act emphasizes the importance of appropriate manufacturing control for products. The PHS Act provides for a system of controls over all aspects of the manufacturing process. In some cases, manufacturing changes could result in changes to the biological molecule that might not be detected by standard chemical and molecular biology characterization techniques yet could profoundly alter the safety or efficacy profile. Therefore, changes in the manufacturing process, equipment, or facilities may require additional clinical studies to demonstrate the product's continued safety, identity, purity and potency.

Because, in many cases, there is limited ability to identify the identity of the clinically active component(s) of a complex biological product, such products are often defined by their manufacturing processes. Changes in the manufacturing process, equipment or facilities could result in changes in the biological product itself and sometimes require additional clinical studies to demonstrate the product's safety, identity, purity and potency. Traditional drug products usually consist of pure chemical substances that are easily analyzed after manufacture. Since there is a significant difference in how biological products are made, the production is monitored by the agency from the early stages to make sure the final product turns out as expected.

With this in mind, SMP Logic Systems endeavored to fully analyze the biologics manufacturing process.  Our products facilitate the introduction of new technologies to improve efficiency and effectiveness of manufacturing process design and control and quality assurance.

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The advancement of cloud computing is allowing the practice of industrial manufacturing to move at a disruptive pace.  In particular, pharmaceutical manufacturers are looking to update pharmaceutical manufacturing processes and plants to decrease costs and increase visibility across the enterprise on a global scale.  Sound facilitation of this endeavor will allow pharmaceutical manufacturers to modernize pharmaceutical processes and close the "technology gap" from legacy systems to modern systems in a cost-effective way that keeps the supply chain intact and keeps inventory levels in-line with commercial production.  SMP's CLOUD LOGIC^TM and INDUSTRIAL CLOUD^TM Product(s) allow SMP to utilize its propietary technology to bring pharmaceutical manufacturing into the cloud.

for more information on our Cloud based solutions and services, please click here - Products 

Nanotechnology holds enormous potential for use in a vast array of products.  Recognizing the emerging nature of this technology and its potential for rapid development, SMP Logic Systems endeavors to foster the continued development of innovative, safe, and effective quality and monitoring systems that utilize nanotechnology materials.

SMP Logic Systems is developing nanomaterials that interact with biological systems in controlled ways and exhibit unique properties and functions because of there small size to provide monitoring and sensing capabilities to pharmaceutical manufacturers.

For more information on our products which incorporate nanotechnology, please click here - Products

Pharmaceutical dosage forms are increasingly important as drugs and delivery systems become more complex.  The principles of pharmaceutical design originated in the art of pharmacy compounding.  Over the past century these practices have steadily been reinforced with science and engineering principles.  Today, most dosage forms are complex multi-factorial physico-chemical systems.  Currently, there is a high degree of uncertainty on the impact independent variable(s) have on product quality and performance.  In addition, new challenges limit product development time and resources used for dosage form design.  The challenges generally relate to significant formulation and process changes often necessary during scale-up and technology transfer and several "bridging" studies (e.g., human bioavailability and accelerated stability testing) needed to ensure an unchanged safety and efficacy profile.  With this current state, SMP Logic Systems looked to build quality into the dosage form. 

In addition, monitoring the quality parameters of the dosage form is becoming and ever-increasing consideration especially for end users in remote locations.  The concept of cold-chain supply management becomes vital.  Especially for end-users in impoverished countries or persons who are subject to natural disasters, etc.  Making sure the medicine is viable when it reaches the end-user is important for everyone involved.