pre-clinical

phase I

phase II

phase III

commercial

PRE-FORMULATION/ FORMULATION PRE-FORMULATION/ FORMULATION The route of administration (IV, IM, or SC) places specific requirements on the formulation regarding the type of excipients (e.g. buffers, bulking agents, solubilizing agents, etc.) and limitation on the volume of the dosage form to be administered. Singota will help to develop pre-formulations of drug products and can optimize them as more information is gathered through the formulation development process. Accelerated stability studies can also be performed on the proposed formulations and packaging components to examine stability and compatibility.	SCALE-UP RECOMMENDATIONS SCALE-UP RECOMMENDATIONS These studies are performed to evaluate the physical characteristics and the manufacturing product parameters when moving from the bench scale to larger volumes. These parameters include compatibility with sterilizing filter membranes, tubing, and stainless steel. Additionally, mixing rates or mixing intensity and the hold-times for unstable solutions can be evaluated to avoid loss of product integrity during manufacturing and/or storage.	METHOD VALIDATION METHOD VALIDATION We perform method validation for client transferred, in-house developed, or optimized analytical methods as an extension of the method qualification process. The validated methods will be cGMP compliant and will follow the guidance regulations established in USP, EP, and ICH.
LYOPHILIZATION & CYCLE OPTIMIZATION LYOPHILIZATION & CYCLE OPTIMIZATION Collapse temperature is determined by DSC and Freeze Dry Microscopy to establish primary drying and/or annealing conditions. FTIR can be utilized to characterize any physical changes to the material during lyophilization. For large molecule formulations, UV-Vis and CE can be used to determine product stability by examining the molecule post lyophilization.	METHOD QUALIFICATION METHOD QUALIFICATION Singota provides analytical support for method development for phase appropriate pharmaceutical studies. Ability to perform USP, EU, or other compendial methods as well as client provided methods. Ensure accuracy with cGMP compliance following guidance of USP, EP, and ICH for analytical method transfers.
ANALYTICAL METHOD DEVELOPMENT ANALYTICAL METHOD DEVELOPMENT Assist in developing/creating analytical methods (e.g. HPLC, CE, UV-Vis (A280), etc.) to support pharmaceutical development studies and regulatory submissions.
QC Release Testing (Chemistry & Microbiology) QC Release Testing (Chemistry & Microbiology) Determine preliminary solubility, stability, and other characteristics of API by performing pH/solubility, pH/stability, hydrophobicity, forced degradation, etc. studies in various solvents. These studies indicate the API’s general physical and chemical characteristics and if it can be formulated as a parenteral solution, emulsion, or suspension, and what excipients provide beneficial attributes to a formulation. Microbiology Singota’s Microbiology department supports testing (bioburden, bacterial endotoxin, and sterility) for the release of the product, microbiological testing on raw materials, and supporting phase appropriate microbial challenge studies (e.g. reconstituted lyophilized or multi-dose products).
Stability Testing QC Release & Stability Testing cGMP testing following compendial or client provided methods for issuance of Certificates of Analysis by our Quality Assurance (QA) Department. Singota can also analyze samples over the duration of a stability study by utilizing qualified storage chambers compliant with ICH guidelines for a designed stability protocol.
Transport Simulation & Thermal Cycling/ Thermal Excursion Studies Transport Simulation & Thermal Cycling/ Thermal Excursion Studies The onsite Transportation Simulation Laboratory (TSL) simulates potential vibration, drop, shock, temperature, and relative humidity fluctuations that a sample in transit could experience as it makes its way across the globe to its final location. Singota can also design and execute TC/TE testing protocols to evaluate product stability as a result of product transportation or handling.


Aseptic Filling Aseptic Filling Our gloveless, robotic aseptic filling workcell provides a state-of-the-art filling process for manufacturing injectable therapies. Utilizing the Cytiva (formerly Vanrx)SA25 Workcell, Singota can fill your parenterals into ready-to-use vials, syringes, or cartridges.

Finishing Services Finishing Services Singota provides customized labeling, kitting, packaging, and inspection services . We specialize in small volume batches needing quick turnaround with demanding specifications or those that require manually intensive procedures to avoid tooling and expensive set-up costs.

SAMPLING/DISPENSING SAMPLING/DISPENSING Aliquot specified weights or volumes of materials into appropriate containers for analytical testing, development, and manufacturing purposes. These operations are performed in our designated cleanrooms held to ISO 8 standards.
MATERIALS MANAGEMENT, STORAGE MATERIALS MANAGEMENT, STORAGE Our secure, cGMP warehouse is equipped to store materials such as APIs, excipients, and finished products in conditions ranging from 15-25°C, 2-8°C, -20°C, and -80°C. We offer our clients 24/7 access to inventory volumes, storage conditions, and quality status through our E-Transparency® web-based system.
Cold Chain Solutions/Transport Process Design & Qualifications Cold Chain Solutions/Transport Process Design & Qualifications Our cold chain experts have the experience and knowledge to manage temperature sensitive materials throughout the distribution process. We provide packaging recommendations, cold chain design and mapping, and shipper qualification services (thermal and physical/mechanical).
Distribution & Clinical Trial Support Distribution & Clinical Trial Support Singota can distribute clinical materials to study sites, ensuring product efficacy and timelines are maintained. We can also manage the return process post study through product destruction.
Commercial & Controlled Substance 3PL Service Commercial & Controlled Substance 3PL Service Singota is a fully licensed 3PL able to provide materials management services and stock resupply to Wholesale Distributors. Singota can manage commercial Medical Devices, Finished Final Dosage Form, and API’s and also maintains the appropriate DEA registrations to manage controlled substances schedules II-V.