Analytical Testing & Support
Robust analytical testing is central to advancing sterile injectable and combination-product programs. Novocol Pharma integrates analytical activities with formulation, fill finish, and device assembly, helping ensure that products meet identity, purity, potency, safety, and performance expectations throughout development. With capabilities spanning chemistry, microbiology, stability, method development, method validation, method transfer, and compendial testing, our teams support both early-stage programs and commercial operations with accuracy, speed, and regulatory discipline.
Analytical Insight That Keeps Sterile Programs on Track
Analytical testing for cartridge, PFS, combination devices, and vials involves unique considerations that extend beyond standard liquid injectables. Device materials and container formats influence method design, and timelines often tighten as programs move from development to clinical supply or later stages.
Common challenges include:
- Ensuring method robustness across container systems
- Managing extractables and leachables
- Navigating method transfer between sending and receiving labs
- Generating complete, audit-ready data packages and documentation
- Designing stability studies that match program needs
- Supporting accelerated timelines between clinical and commercial scale
Novocol Pharma helps our clients anticipate these challenges and build analytical strategies that stay aligned with manufacturing and regulatory expectations.
How Container Format Shapes Analytical Strategy
Because container systems influence analytical behavior, Novocol Pharma adapts strategies based on the delivery format.
Cartridge Testing Needs
Cartridges introduce mechanical and material considerations such as closure integrity, extractables and leachables, uniformity across fill volume, and interaction with pen or needle systems. Stability behavior can also vary due to cartridge geometry and surface interactions. Device stability studies and in-use stability studies can also be conducted to simulate real-world patient use of combination devices.
PFS Testing Needs
Syringe-based products require evaluation of plunger movement, silicone distribution, container–closure integrity, and potential interactions that influence potency, purity, or particulate levels during storage.
Across both formats, analytical testing is tightly connected to device behavior, and Novocol Pharma’s cartridge/PFS heritage provides practical insight for troubleshooting and risk reduction.
Comprehensive Analytical Capabilities for Every Stage of Your Program
Novocol Pharma provides a wide range of analytical services, designed to support sterile injectables throughout the product lifecycle. Activities span chemistry, microbiology, development, validation, and stability management.
Capabilities include:
Method development and validation
Method transfer, qualification, and comparative testing
Release and stability testing for sterile injectables
Compendial testing aligned with USP, EP, JP, and other requirements
Identity, potency, purity, and impurity assessments
Container-closure integrity evaluation and E&L planning
Analytical support for sterile formats and peptide-containing products
Rigorous documentation and regulatory support
These services are supported by strong interaction between analytical, development, and manufacturing teams, helping ensure methods remain fit for purpose as programs advance.
Supporting Technologies and Facilities
Analytical work at Novocol Pharma is grounded in a robust infrastructure spanning chemistry, microbiology, and stability management.
Within Microbiology, Novocol Pharma maintains a 24/7 operational model for sterility testing, bioburden, endotoxin evaluation, growth promotion, and environmental monitoring across all manufacturing spaces. The group also performs rapid microbial identification using MALDI-TOF, enabling genome-level identification and faster turnaround times.
Quality control chemistry activities support raw material testing, method feasibility, transfer, verification, and validation. Specialized instrumentation includes ICP for elemental and heavy-metal testing, as well as universal testing systems for break-loose and glide-force assessments, providing insight into how formulations and devices interact during actual use and over the stability shelf life.
These capabilities are integrated with method lifecycle practices outlined in Novocol Pharma’s analytical workflow, including analytical target profile definition, feasibility runs, comparative testing transfer strategies, and validation approaches aligned with regulatory expectations.
This infrastructure helps ensure analytical readiness at every stage from development through commercial release.
