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