Singota Solutions
Singota Solutions is a Bloomington, Indiana-based CDMO specializing in early-phase drug development, formulation development, and aseptic fill-finish projects. They focus on small-batch, high-quality, and compliant manufacturing processes, leveraging state-of-the-art robotic technology. Their expertise includes optimizing formulation strategies, pre-formulation assessments, analytical method development, and supply chain management, with a strong emphasis on accelerating drug development timelines and supporting clients through strategic, technical, and logistical solutions.
Industries
Nr. of Employees
medium (51-250)
Singota Solutions
4320 W Zenith Dr, Bloomington, IN 47404
Products
Aseptic Manufacturing
Manufacturing of small volume parenterals, including vials, syringes, and cartridges, using advanced aseptic technology.
QC Testing & Development
GMP testing and formulation & method development to ensure product quality and efficacy from inception to production.
Supply Chain Management
Comprehensive services including sourcing, production, inventory management, regulatory compliance, shipping validation studies, and distribution.
Pre-Formulation & Formulation Development
Development and optimization of formulations for small molecules, oligonucleotides, vaccines, peptides, biosimilars, mAbs, and large proteins.
Process Development
Solutions for drug formulation process development to ensure reliable product manufacturing as it moves through clinical trials to commercial production.
Analytical Development
Creation and optimization of robust analytical methods for product analysis, including method validation, qualification, and transfer.
Aseptic Manufacturing
Manufacturing of small volume parenterals, including vials, syringes, and cartridges, using advanced aseptic technology.
QC Testing & Development
GMP testing and formulation & method development to ensure product quality and efficacy from inception to production.
Supply Chain Management
Comprehensive services including sourcing, production, inventory management, regulatory compliance, shipping validation studies, and distribution.
Pre-Formulation & Formulation Development
Development and optimization of formulations for small molecules, oligonucleotides, vaccines, peptides, biosimilars, mAbs, and large proteins.
Process Development
Solutions for drug formulation process development to ensure reliable product manufacturing as it moves through clinical trials to commercial production.
Analytical Development
Creation and optimization of robust analytical methods for product analysis, including method validation, qualification, and transfer.
Services
Automated aseptic fill–finish for vials, syringes and cartridges focused on small-batch clinical supply with flexible scheduling and reduced human contamination risk.
Pre-formulation characterization, excipient selection, solubility enhancement strategies, dosage form design and sterile formulation development to optimize stability, bioavailability and manufacturability for injectable products.
Chromatography and mass spectrometry method development and transfer, stability-indicating assay development, microbiology testing and generation of stability data to support release and regulatory filings.
CCIT, reconstitution studies and material compatibility testing to support packaging qualification and product release.
Clinical trial labeling, blinded kit assembly, de-labeling and re-labeling, and pack-out operations to prepare investigational product for distribution.
Temperature-controlled storage across multiple setpoints, bonded warehouse services and integrated logistics for global distribution of investigational and clinical products.
Automated aseptic fill–finish for vials, syringes and cartridges focused on small-batch clinical supply with flexible scheduling and reduced human contamination risk.
Pre-formulation characterization, excipient selection, solubility enhancement strategies, dosage form design and sterile formulation development to optimize stability, bioavailability and manufacturability for injectable products.
Chromatography and mass spectrometry method development and transfer, stability-indicating assay development, microbiology testing and generation of stability data to support release and regulatory filings.
CCIT, reconstitution studies and material compatibility testing to support packaging qualification and product release.
Clinical trial labeling, blinded kit assembly, de-labeling and re-labeling, and pack-out operations to prepare investigational product for distribution.
Temperature-controlled storage across multiple setpoints, bonded warehouse services and integrated logistics for global distribution of investigational and clinical products.
Expertise Areas
- Aseptic fill–finish for injectable parenteral products
- Pre-formulation and formulation development for injectables
- Solubility enhancement and excipient selection
- Analytical method development and stability-indicating testing
Key Technologies
- Robotic isolator aseptic filling
- UHPLC/HPLC
- Liquid chromatography–mass spectrometry (LC–MS)
- Electronic Laboratory Notebook (ELN), LIMS and EDC systems
News & Updates
Singota Solutions announced the opening of a new facility in Balerna, Switzerland, expanding its European presence to three sites. The new 100,000 sq ft facility offers cold chain storage, open bonded warehouse status, and regulatory compliance, supporting global pharmaceutical logistics.
Singota has transformed into a fully electronic laboratory environment, integrating ELNs, LIMS, and EDC systems to enhance speed, traceability, and compliance in drug development.
The new facility in Balerna, Switzerland, was highlighted as a milestone in Singota’s global growth, offering advanced cold chain storage and regulatory flexibility.
First commercial site in North America to offer the SA25 Aseptic Filling system
Singota was the first in North America to utilize the robotic SA25 aseptic filling system, delivering an unblemished sterility record.
Over 40 successful regulatory and client audits per year
Singota maintains a strong compliance record with over 40 audits annually, demonstrating system robustness.
Singota Solutions announced the opening of a new facility in Balerna, Switzerland, expanding its European presence to three sites. The new 100,000 sq ft facility offers cold chain storage, open bonded warehouse status, and regulatory compliance, supporting global pharmaceutical logistics.
Singota has transformed into a fully electronic laboratory environment, integrating ELNs, LIMS, and EDC systems to enhance speed, traceability, and compliance in drug development.
The new facility in Balerna, Switzerland, was highlighted as a milestone in Singota’s global growth, offering advanced cold chain storage and regulatory flexibility.
First commercial site in North America to offer the SA25 Aseptic Filling system
Singota was the first in North America to utilize the robotic SA25 aseptic filling system, delivering an unblemished sterility record.
Over 40 successful regulatory and client audits per year
Singota maintains a strong compliance record with over 40 audits annually, demonstrating system robustness.