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 products parameters that the sample will be exposed to during the manufacturing process. These parameters include compatibility with sterilizing filter membranes, tubing, and stainless steel. Additionally, holding times for unstable solutions can be determined 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. Ensure accuracy with cGMP compliance following guidance of USP, EP, and ICH for analytical method transfers.

 
LYOPHILIZATION & CYCLE OPTIMIZATION

LYOPHILIZATION & CYCLE OPTIMIZATION
Collapse temperature is determined by DSC and Freeze Dry Microscopy to establish primary drying conditions and if annealing is required. FTIR and XRD techniques can be utilized to characterize any physical changes to the material during lyophilization. For large molecule actives, UV-Vis and CE can be used to determine active stability by examining the molecule post lyophilization.

METHOD QUALIFICATION

METHOD QUALIFICATION
Singota provides analytical support for development and 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, etc.) to support pharmaceutical development studies and regulatory submissions.

       
Forced Degradation & Excipient Studies

Forced Degradation & Excipient Studies
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.

     
QC Release & 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 a range of qualified storage chambers compliant with ICH guidelines to the designed testing protocols.

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 could experience as it makes its way across the globe to its final location. Singota can also design and execute TC/TE temperature and testing protocols to determine product stability in thermal excursions as might be experienced during 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 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, and packaging 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. In addition, we offer inspection services.

 
 
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 status and environmental conditions 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 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 also manage the return process post study through product destruction.