Special Unit Operations
CRAMSN Research Park provides flexible and scalable manufacturing solutions with a diverse range of unit operations suited for various APIs. Our facilities support these operations from lab scale to GMP production, ensuring seamless scale-up. Equipped to handle essential processes such as reactions, mixing, extraction, distillation, crystallization, filtration, and drying, we also specialize in powder processing and advanced purification techniques. Our capabilities extend to specialized drying methods like ATFD and spray drying for heat-sensitive materials, column chromatography for racemic purification, hydrogenation, and lyophilization. With containment facilities for high-potency compounds, we ensure precision, efficiency, and regulatory compliance in API manufacturing.
Commitment to Safe & Sustainable Manufacturing Technology Tranfer
Spray drying is an efficient method for converting liquids into dry powders using rapid hot air drying. This technique is particularly useful for thermally sensitive compounds, achieving finer particle size distribution, or producing amorphous polymorphs. CRAMSN Research Park offers spray drying solutions from lab to manufacturing scale, with state-of-the-art spray dryers capable of handling evaporation rates up to 10 kg/hour in both non-potent and high-potency facilities. Our expertise ensures precision, consistency, and scalability for diverse pharmaceutical applications.
Agitated Thin Film Driers (ATFD)
Agitated Thin Film Dryers (ATFDs) are used to convert crystalline compounds into their amorphous form, making them ideal for heat-sensitive compounds, low-residence-time processes, and amorphous form development. At CRAMSN Research Park, we offer ATFD solutions from lab to plant scale, with a maximum capacity of 3.5 sq. m. Our facilities support both regular and high-potency APIs, ensuring efficient drying with precision and scalability.
Micronization
Micronization is a key process for enhancing the solubility and bioavailability of APIs by reducing particle size. Our manufacturing facilities are equipped with multi-mills, air jet mills, micronizers, sifters, and blenders to achieve precise particle size control. We also offer micronization in high-potency and steroidal blocks, ensuring safe and efficient processing for specialized compounds.
Hydrogenation
CRAMSN Research Park offers comprehensive hydrogenation capabilities, supporting a wide range of catalysts and pressure ratings for seamless scale-up. Our facilities can handle hydrogenation reactions from small-scale (5L) in a GMP environment to large-scale (6KL) operations, with pressure capacities of up to 10 bars. With advanced infrastructure and expertise, we ensure precision, efficiency, and scalability in hydrogenation processes.
Cryogenic Reactions
CRAMSN Research Park is equipped with multiple cryogenic reactors ranging from 200L to 12,000L , enabling precise temperature control for sensitive reactions. Our facilities include stainless steel and Hastelloy reactors, with specialized setups for steroidal compound manufacturing. With advanced infrastructure, we ensure safe, efficient, and scalable cryogenic processing.
Reverse-phase High-Performance Liquid Chromatography (RP-HPLC)
Reverse-phase HPLC (RP-HPLC) is a highly efficient and versatile method for peptide purification, utilizing hydrophobic interactions for selective separation. At CRAMSN Research Park, we offer RP-HPLC capabilities from lab to plant scale, with column diameters ranging from 50 mm to 800 mm. Our advanced purification setup ensures high-resolution separation with scalability, optimizing both purity and process efficiency.
Ion Exchange
Ion exchange chromatography is a highly effective technique for purifying charged molecules through selective ionic interactions. This process enhances compound purity by retaining impurities on the charged matrix while eluting the target compound in solution. At CRAMSN Research Park, we offer ion exchange chromatography from lab to production scale, with a capacity of 350 mm diameter, ensuring efficient and scalable purification.
Lyophilization
CRAMSN Research Park offers both manual and automated peptide synthesizers, enabling flexible scale-up for peptide development. Our process is supported by ion exchange and RP-HPLC columns for efficient purification, followed by lyophilization to obtain the final compound. We operate across both development and manufacturing areas, providing 20–50g of non-GMP material for early-stage research and 100 kg to multi-kilo batch sizes for commercial supply, ensuring seamless scalability and compliance.
