We provide engineering services through all aspects of process development, enabling value-added solutions that scale to meet your needs.
Nalas offers world-class chemistry expertise to our customers to assist in the design and optimization of their chemistry. Nalas offers a unique model for accelerated process development of specialty chemicals, APIs, or their precursors. The bond forming steps and subsequent isolation steps are the cornerstone of process development; the enabling chemistry is critical to a successful project. The Nalas model relies on strong synergy between the synthetic chemist, analyst and chemical engineer, which allows for an early focus on process scale-up.
Our chemists are well trained in organic chemical synthesis as it relates to pharmaceutical process development and fine chemical synthesis. With decades of combined experience, our team of scientists is well suited to tackle the most challenging of your chemical synthesis problems.
Nalas is committed to using the best technology for each chemical synthesis reaction. Use of flow chemistry and continuous manufacturing enables the safe use of otherwise “forbidden” reagents, or hazardous, exothermic chemistries. Nalas’s team of chemists and engineers are experts in translating small scale flow chemistry syntheses to kilogram and production scale.
Organic electrochemistry has recently seen a resurgence as a green, low cost synthesis method that has many advantages over traditional reagent based approaches. Nalas has extensive electrochemistry capability, including IKA Electrasyn for batch divided and undivided cell electrochemistry, and plate-and-frame cells for flow electrochemistry.
Nalas utilizes both batch and flow chemistry to enable robust, scalable photochemical syntheses of our customer’s products. Some examples of photochemical reactions that our team has enabled include:
Singlet oxygen oxidation
Crystallization, including recrystallization, is one of the oldest chemical engineering unit operations and possibly one of the most challenging to master. Nalas chemists and engineers are experts at evaluating processes to obtain the correct polymorph, particle size, morphology, and impurity profiles.
Nalas uses screening tools such as Crystal16 for generating solubility and supersaturation curves and screening crystallization solvents. In situ monitoring tools including Mettler Toledo FBRM, PVM, Turbidity and EasyViewer probes allow for collection of crystallization rate data, as well as particle morphology information for fast optimization of your crystallization process.
In Situ Reaction Monitoring
Data rich experimentation via in situ reaction monitoring is crucial for speeding reaction process development. Nalas is equipped with in situ IR, Raman, Particle View Microscopy (PVM), Focused Beam Reflectance Measurement (FBRM), EasyViewer, pH, turbidity and Mettler Toledo EasySampler and Bruker FlowNMR.
Filtration & Drying
Filtration and drying are important unit operations that can have a dramatic effect on process cycle times as well as product properties, e.g. particle size, hydrate or solvate. Nalas is equipped with the hardware and modeling tools to provide predictive scale-up models for filtration and drying times in agitated filter driers.
Polymorph and solvate screening activities along with an understanding of the solvent mediated phase transformations that will impact your manufacturing process are critical to developing a robust and selective crystallization process.
X-ray powder diffraction and polarized light microscopy are routinely employed to map structure and morphology of new and existing solid forms.
Single crystal growing experiments leads to structure solution by single crystal x-ray diffraction. Adjunct to single crystal growing experiments morphology screening activities have been implemented to provide a prescriptive method to alter the crystal shape with an eye to optimizing filtration, bulk flow, and consolidation processes.
Nalas provides crystallography services to develop the fundamental understanding of structure directing intermolecular interactions that impact physical and chemical stability, solubility, and bulk properties. Nalas will grow single crystals for structure solution by x-ray diffraction to gain insight into the fundamental difference and performance of salts, cocrystals, solvates, and polymorphs.
Scanning Electron Microscopy (SEM)
SEM images of powders, metals, polymers, and composite materials provide information on
the materials three dimensional morphology, degree of agglomeration, and interactions at
the individual crystal or particulate level. One can gain insight into the number and type of
surface imperfections, potential surface interactions, and possible mechanism for crystal
growth or particle formation.
Nalas employs a TA Instrument HR20 Rheometer to determine your samples linear viscoelastic material functions. By understanding the polymer material or semisolid formulations flow properties the processing conditions can be optimized for meet specific performance criteria. Tests to determine the rheological molecular weight, storage and loss modulus, isothermal melt viscosity, the temperature dependence of the melt viscosity are available to aid in formulation development activities or optimize polymer chemistry reactions.
Synthesis and Process Development
In situ tools to monitor solid form or off line IPC to assess transformations. See our Polymorph Chemistry offerings to learn more about our synthesis and process development.
High Potency Compounds
Nalas maintains an Isolator, fume hoods, and SOPs tested to handle compounds with projected Occupation Exposure Limits below 20 ng/m³/8 hours total weighted average (TWA).
The MBraun Isolator Pro containment isolator is qualified to <20 ng/m³/8 hours TWA via surrogate testing. The stainless steel isolator is outfitted with HEPA filtration and two Integrated material transfer chambers.
Three ‘modular’ spaces within the adjacent fume hood support high potency experiments facilitate adding support instruments as the project demands.
In/out transfer, analytical sample preparation, waste containers
Mettler-Toledo EasyMax™, 50-mL, 100-mL glass reactors, dosing unit, TR probe, and a selection of impellers for overhead stirring
Top loading balance, 4-place balance, temperature-controlled chamber
In situ tools: PVM, EasyViewer, FBRM, and Raman probes sit adjacent to the hood for data rich experiments.