Mares | Consulting, Gene Therapeutics and Beyond

Gain Insights into Aseptic
Manufacturing, Controls
and Facilities

Reconstruct scientific processes
based on EU requirements

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Understanding Clinical Trial
Applications and Medicinal Products

Gain transparent insights into GMP audits and QP services

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Invest in the Future of
Advanced Healthcare

Explore the results of Advanced Therapy
Medicinal Products

Transform the Potential and
Efficacy of Cell Therapeutics

Redefine gene therapy and research with us

In simple words, the power of cell therapeutics is in modifying/changing the structure of a patient's own cells from a viable donor in order to fight diseases and improve underlying health conditions.

At Mares ITX, you gain access to solutions that are spread across cellular therapy, aseptic processing, consulting services and a wide range of advanced technologies.

On the other hand, the power of gene therapies in the medical field can empower the body's ability to fight diseases and restore equilibrium, which is scientifically proven.

Gene and cell therapeutic services at Mares can help mitigate medical complexities and pave the way for advanced technologies for state-of-the-art healthcare.

Innovation & Products Process Development Aseptic Processes Quality Processes & Designs

Innovation & Products

Macro-Scale Innovation & Products

The primary goal of innovation is to produce something extraordinary from the mundane.

Considering the impact of technology in the healthcare industry, Advanced Therapy or Advanced Therapy Medicinal Products are certain to change the game of how pharmaceuticals and hospitals operate.

At Mares, you are empowered with:

Technical, quality and regulatory expertise – Know/How.

Aseptic technologies and processes.

Designs, permissions from authorities and custom-built infrastructure.

Quality checks so you don't miss out on anything.

Process Development

Process Development & Interpretation

The Process Development phase includes collecting relevant evidence supporting a client/partner. Upon validating and reviewing the data, a manufacturing process is devised and agreed.

Furthermore, based on the results, Process Development steps are checked for reliability, robustness, approval and scalability.

At Mares, we ensure you are equipped with:

Product specifications and quality features.

Robust, economical and scalable product processes.

Top-notch technologies and equipment.

Aseptic Processes

Aseptic Processes & Designs

Aseptic Processing is the process of packaging a sterile product into sterilized containers to avoid microbiological contamination.

Here at Mares, based on the client's process and requirements, we design state-of-the-art manufacturing plants. Additionally, you can be rest assured about process transparency, flow of goods and monitoring environmental procedures.

Quality Processes & Designs

Quality Processes and Systems

Adhering to EU-GMP and PIC/S regulatory guidelines,
Mares Consulting offers quality systems that include:

Process and Quality Manuals.

Site Master Files.

Work Sheets.

SOPs.

Equipment Qualification

This involves:

Hygienic rooms and equipment used in GMP manufacture qualified before use.

Nature of equipment, User Requirement Specifications (URSs) and Requirement Traceability Matrices (RTMs).

Design, installation and operations.

Factory Acceptance Tests (FATs)/Site Acceptance Tests (SATs).

Equipment risks assessments.

Failure mode analysis based on quality (Pre and Post Approval).

Process Simulation, Validation and Audits

Originally referred to as Media Fill, process simulation is the main tool in demonstrating the ability to complete Aseptic processes while maintaining Aseptic conditions. Although process simulation is not a 1:1 reflection of the procedure, it mirrors subsets of the projected process in a fully controlled environment using microbial growth media rather than process liquids.

Once the process is defined, process simulation begins using qualified available equipment. Subsequently, validation reports are generated documenting successful process completion.

Drug manufacturers are held responsible for the quality of their products and suppliers. At Mares ITX, we provide audit services for partners planning to enter the EU market from other countries.

Risk Assessments

According to Tripartite ICH Q9 guidelines, drug manufacturers must maintain Quality Risk Management (QRM) systems to avoid unforeseen risks.

Mares offers QRM systems for our clients and integrates them with their quality systems.

Furthermore, we conduct risk assessments and generate necessary documentation so our clients are in compliance with QRM.

Regulatory

Regulatory Compliance

Once an organization or an independent business group decides to produce a drug directed for human usage in the European Union, a manufacturing permit is mandatory.

This includes a full review of quality processes, manufacturing plant and relevant system documentation.

Furthermore, a QP or a Qualified Person is eligible and competent to release products.

Good news? Mares offers QP services so you don't look any further!

Innovation & Products