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Pharmaceuticals 

Conventional pharmaceutical manufacturing is generally accomplished using batch processing with laboratory testing conducted on collected samples to evaluate quality.  This conventional approach has been successful in providing quality pharmaceuticals to the public. 

However, today SMP Logic Systems has identified significant opportunities for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis, and process control through the use of our software platforms.

Unfortunately, the pharmaceutical industry generally has been hesitant to introduce innovative systems into the manufacturing sector for a number of reasons.  One reason often cited is regulatory uncertainty, which may result from the perception that our existing regulatory system is rigid and unfavorable to the introduction of innovative systems.  For example, many manufacturing procedures are treated as being frozen and many process changes are managed through regulatory submissions.  In addition, other scientific and technical issues have been raised as possible reasons for this hesitancy.

In light of the FDA's current initiatives relating to pharmaceutical manufacturing.  SMP Logic Systems has taken the scientific and technical uncertainty away from the pharmaceutical manufacturers.  Our research has revolutionized the pharmaceutical manufacturing process.  Whether you are manufacturing active pharmaceutical ingredients (API), excipients, or final drug product(s), our Quality by Design (QbD) approach allows manufacturers to produce drug products that are free from contamination, consistently reproducable, and consistently deliver the therapeutic benefit promised in the label in any dosage form.

At SMP Logic Systems our goal is to provide our clients a means to design and develop formulations and manufacturing processes to ensure predefiined product quality.

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Vaccines

Vaccines are an extremely cost-effective public health measure; however they must be consistently manufactured in a manner such that they are safe and effective, requiring, for example, that each lot produced must be the same as the next. In order to assure the quality of vaccines, meaningful tests must be developed, evaluated, validated, and conducted at all stages of the manufacturing process, both during the clinical trials used to evaluate the safety and efficacy of the vaccine as well as after licensure.  These meaningful tests must be designed and evaluated to support the safety, purity, and potency of vaccines, by determining the assays that focus on key parameters that will best measure these important parameters.

SMP Logic Systems research programs are developed through rational top-down design and evaluate in-process tests, lot release tests, and clinical studies for vaccines as well as continuous monitoring during the entire manufacturing process.

Whether you manufacture live attenuated virus, inactivated toxoids, activated or inactivated subunits, DNA vaccination, or synthetic vaccines SMP Logic Systems has products to revolutionize your manufacturing.

To view our products, please click here - Products

Biologics

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.


To view our products, please click here -
Products

Industrial Internet of Things ("IIoT")

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 LOGICTM and INDUSTRIAL CLOUDTM 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 

Nanotechnologies

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

Dosage Forms

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.

SMP Logic Systems research is developing monitoring systems and methods to assess quality of dosage forms throughout the supply-chain.  To view products relating to our dosage form technology, please click here – Products

Supply Chain Management

Proper supply chain management of packaged drugs is critical to provide quality drugs to end-users.  This includes monitoring traditional areas of the supply chain including vial inspection, packaging, product protection, storage, and distribution.  Specifically, from the point the drug is packaged until it reaches the end-user to all points in between.  Additionally, the Drug Supply Chain Security Act (“DSCSA”) mandates a federal, interoperable track-and-trace system, in which all players in the drug supply chain are required to develop a system that will allow for (i) product identification; (ii) product tracing; (iii) product verification; (iv) detection and response; (v) notification; (vi) wholesale licensing; and (vii) Third-Party logistics provider licensing.  

These requirements include providing product and transaction information at each sale with Lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.  Based on the need for manufacturers and distributers to become compliant under the DSCSA, SMP endeavors in the areas of product serialization to enable all stakeholders to facilitate serialization and e-pedigree requirements.

To discuss endeavors of our Solution Based Services in the area of product serialization, please click here – Products

To contact and SMP Logic Systems Representative, please click here - info@smplogicsystems.com