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Thermo Fisher Scientific provides an extensive range of spectroscopy instruments and software, extrusion and rheological tools and service and support.
This allows pharmaceutical labs to secure quality and product safety while complying with regulatory standards throughout the drug development and formulation processes.
Chemical and biological must meet rigorous quality and regulatory requirements in order to develop drugs that are safe.
The Thermo Scientific spectroscopic and extrusion portfolio promotes the research work and facilitates quality and regulatory compliance throughout the drug formulation, development and manufacturing processes.
Thermo Scientific’s experienced team functions as a pharmaceutical lab partner to always assist its customer’s efforts. This is made possible due to the available selection of advanced spectrophotometers and software to guarantee compliance with the latest regulatory requirements.
In addition to spectroscopy and materials characterization tools, Thermo Scientific offers solutions in:
Thermo Scientific’s extensive portfolio includes X-ray plasmon spectroscopy (XPS), energy-dispersive spectroscopy (EDS), Raman, Fourier-transform infrared (FTIR), near-infrared (NIR), X-ray diffraction (XRD), rheometers and ultraviolet-visible (UV-Vis) spectroscopy.
Using advanced and innovative instruments, customers are guaranteed quality control across all steps and phases of the workflow, supplying drug product consistency from early formulations to large-scale production, utilizing rapid, non-destructive methods.
Thermo Scientific Pharmaceutical Extruders enable the production of consistent API dispersion in drug formulation labs, from initial research through clinical trials and production.
This is made possible with three different sizes of twin-screw extruders that present the possibility of hot melt extrusion (HME) and wet granulation (twin-screw granulation or TSG) capabilities.
When additional help or service is required, Thermo Scientific’s services and support teams can offer the repair of key instruments as well as after-sales service and support.
Concerning software requirements, customers can secure laboratory data confidently, ensuring that it is compliant with data security regulations using Thermo Scientific’s latest software solutions.
Thermo Scientific Security Suite Software can be paired with several analytical software tools to supply the data integrity required to meet 21 CFR Part 11 regulations for electronic documents.
The Thermo Scientific™ SolstiX™ XRD Software with Security Suite package is readily available with the company’s complete ARL™ EQUINOX XRD range and permits 21 CFR Part 11 compatibility.
Many of Thermo Scientific’s instruments allow customers to take advantage of crucial compliance solutions built into the instrument software (for instance, the Thermo Scientific Evolution™ 350 UV/Vis Spectrophotometer includes 21 CFR Part 11, USP and PHEUR compliance).
The Thermo Scientific Nicolet™ Summit FTIR Spectrometers, NanoDrop™ One UV-Vis, Evolution UV-Vis and ARL EQUINOX XRD systems all promote endorsed configurations for pharmaceutical QA/QC that follow the strict 21 CFR Part 11 requirements.
Thermo Scientific OMNIC™ Paradigm Software gathers data, evaluates samples and produces workflows. All spectral data is saved in a central database, which offers increased data storage flexibility and security.
Many of these software solutions supply traceability with complete audit trails, always making sure the integrity of data is well-maintained throughout its life cycle.
From research to production, Thermo Fisher Scientific allows pharmaceutical labs to create safe and effective drugs that comply with stringent regulatory requirements.
By offering a complete spectroscopy and materials characterization tool set, intuitive data analysis software and one of the industry’s biggest service and support organizations, Thermo Scientific helps drug producers guarantee quality from start to finish.
Table 1. Source: Thermo Fisher Scientific – Materials & Structural Analysis
When purchasing instrumentation from Thermo Fisher Scientific, customers are introduced to a partnership with an experienced team who they can count on for assistance throughout the workflow.
Thermo Scientific delivers comprehensive, worldwide application support and training, after-sales customer service, instrument compliance solutions and an international, world-class support network.
Thermo Scientific can use the combined experience of its entire organization to assist customers in the successful navigation of the drug discovery and development environment to distinguish, assess and obtain regulatory approval for marketing a drug product.
Thermo Scientific is on hand to support its customers along the complex pathway, no matter how challenging, from R&D through to preclinical studies and clinical trials, to the final review and approval of a commercial product.
How do the Thermo Scientific spectroscopic analytical instruments and services optimize the pharma/biopharma workflow?
Thermo Scientific’s instruments provide dependable, stable performance with great reproducibility. Its team can help customers select, use and service their tools to guarantee drug quality, safety and speed to market.
When paired with cutting-edge software, an instrument can capture the data required throughout the workflow to meet quality needs. This includes 21 CFR Part 11 compliance, GMP guidelines, pharmacopoeia (USP and EP) requirements while producing the reports necessary for regulatory filings.
Each qualified installation, in cooperation with world-leading technical service and support experts, sets the stage for a successful journey through the workflow. The technology and method that customers choose can help release analytical benefits at each stage of the process:
Table 2. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Thermo Scientific’s team of pharmaceutical experts will assist its customers and help them achieve product development goals.
They can also help customers select the right instrument for any given workflow, whether just starting or ready to move from the pilot-scale in research and discovery to the small-to-medium scale batches needed in the development and clinical study phases and ultimately to commercial-scale manufacturing with continuous processes.
For granulation and extrusion, Thermo Scientific’s support experts can help customers make the best choices on size and compatibility with upstream and downstream processes that satisfy formulation needs at all research, development and production stages.
When working through the feasibility studies phase, the Thermo Scientific™ Pharma mini HME Micro-Compounder can conduct rapid and early assessment of new API/excipient formulations and help determine drug candidates for hot melt extrusion by combining as little as three grams of material.
When customers are ready to scale up, especially when in possession of a promising, new API that cannot otherwise be solubilized, Pharma 11, Pharma 16 and Pharma 24 twin-screw extrusion technology can help overcome such obstacles.
Finally, when customers are ready to streamline manufacturing, Thermo Scientific are on hand to help seamlessly integrate in-line analysis equipment and accessories upstream (like feeders) and downstream (like dryer, coating and forming technology) for an improved, continuous production process.
Table 3. Source: Thermo Fisher Scientific – Materials & Structural Analysis
* No TSG option * Depending on formulation * All parallel screw designs are interchangeable between HME and TSG operation All extrusion instruments are made of pharma-grade steel and allow you to meet GMP compliance standards.
Table 4. Source: Thermo Fisher Scientific – Materials & Structural Analysis
❱ Simultaneous analysis of multiple components
❱ Comply with quality and regulatory standards
Basic research and feasibility study methods motivate an understanding of the underlying disease mechanism while identifying the therapeutic target and facilitating appropriate selection of likely drug candidates for that target to progress to the next step in the process.
Discovery integrates assay development and high-throughput screening methods to advance the identification, analysis and characterization of the most promising small molecule and biotherapeutic compounds.
It also assesses how the candidates act in testing in vitro and in vivo with drug, metabolism and pharmacokinetic (DMPK) studies and subsequently choosing how to appropriately formulate the drug for delivery.
Table 5. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Table 6. Source: Thermo Fisher Scientific – Materials & Structural Analysis
This step moves into pilot-scale development of the drug, tackling the analytical methods, process chemistry, process development and optimization and approaches for scale-up.
Early development also embraces the formulation process to evaluate the optimal composition and compounding method of the active pharmaceutical ingredient (API) and other components necessary for safe, timely and effective delivery to the therapeutic target.
Table 7. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Table 8. Source: Thermo Fisher Scientific – Materials & Structural Analysis
This step covers the typical Phase I, Phase II and Phase III clinical trial aspects with human participant groups in increasing scale.
While Thermo Scientific’s instrument portfolio has been designed for research use and not mapped to methods or applications for use with human samples, some of its instruments can be useful when adjusting the upcoming manufacturing process to optimize solubility and bioavailability of the API (HME), or to manage the integration of continuous manufacturing (TSG).
Table 9. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
Table 10. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
This step addresses the process scale-up that takes place in industrial-scale manufacturing, as well as the tasks associated or involved with surrounding procedure and production.
Table 11. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Table 12. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
Quality control and assurances during the pharma process include routines to help determine potential drug contaminants, guarantee product consistency and safety and maintain regulatory compliance.
Thermo Scientific’s instruments not only develop the drugs but also assist in the analysis and recording of data from inbound and raw materials through outbound and finished goods across the complete workflow process.
Its team can supply excellent service and support critical, making sure downtime remains minimal throughout the process and when a customer is ready to release a batch or crucial product.
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
Table 13. Source: Thermo Fisher Scientific – Materials & Structural Analysis
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
Thermo Fisher Scientific’s instruments and services analyze, qualify and manage product quality, helping assure customers in the delivery of safe, world-leading solutions:
Thermo Fisher Scientific recognizes the importance of instrument uptime in pharmaceutical QA/QC labs. Therefore, it offers an extensive range of service offerings to guarantee timely response and repair of mission-critical instruments.
Thermo Fisher Scientific’s comprehensive, global after-sales service and support, including instrument installation, applications support, on-site technical consultancy, instrument qualification, and compliance services.
Thermo Scientific’s customers can also take advantage of its premier offering, which includes a two-day on-site response or industry-exclusive no-charge requalification guarantee when adding OQ to a qualifying plan - hassle-free help with audit readiness for GMP compliance.
Additionally, with a global team of expert consultants, Thermo Scientific can also help its customers understand 21 CFR Part 11 and pharmacopeia requirements as they navigate complex industry demands.
Make use of Thermo Scientific’s extensive expertise to reach the potential of discovery.
With a global business infrastructure and experienced key account management team, Thermo Scientific can offer outstanding post-sale support to follow instrument installation.
This is conducted by certified engineers who are on hand to respond to customer requests for calibration service, routine maintenance, corrective maintenance repairs, emergency response and other warranty and post-warranty service contracts.
Thermo Scientific also has instructors who have developed and used the product, developed the applications and methods and maintained the instruments to help train customer teams.
Image Credit: Thermo Fisher Scientific – Materials & Structural Analysis
Thermo Fisher Materials and Structural Analysis products give you outstanding capabilities in materials science research and development. Driving innovation and productivity, their portfolio of scientific instruments enable the design, characterization and lab-to-production scale of materials used throughout industry.
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Last updated: Aug 26, 2021 at 3:44 AM
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