Formulation & Development
Strong formulation and development work begins with understanding how formulations behave within real devices and real manufacturing conditions. Novocol Pharma approaches development with a device-first perspective, aligning formulation decisions with analytical readiness, manufacturability, and downstream fill finish needs. Early integration with SMEs and technical project management helps our clients de-risk development and prepare for smooth scale-up and tech transfer.
Understanding the Development Challenges Unique to Sterile Drug Device Products
Injectable programs behave differently from conventional formulations because hardware, materials, and patient-use expectations all shape what is possible. This complexity becomes more pronounced in cartridge and PFS systems, where formulation choices must account for mechanical forces, component interaction, and delivery requirements.
Some of the factors that drive this complexity include:
Compatibility with materials composition, stoppers, plungers, and needles
Viscosity and injection performance in patient-ready formats
Changes in material behavior across temperature, fill volume, and shear conditions
Early decisions that 
set the trajectory for manufacturability, regulatory alignment, and device assembly
Novocol Pharma’s development teams anticipate these challenges early, ensuring that formulation strategies reflect the true constraints and opportunities of device-driven delivery.
How Device Format Influences Formulation Strategy
Because Novocol Pharma specializes in cartridge and PFS formats, development decisions are grounded in an understanding of how formulations interact with real components, materials, and delivery pathways. Rather than treating formulation as an isolated function, the team evaluates how the product will behave as a complete system.
Cartridge Considerations
Cartridge development requires careful attention to mechanical interfaces, siliconization profiles, uniformity, thermal behavior, and stability characteristics. Break loose force, glide force, and seal integrity are evaluated early to shape formulation and process decisions.
Prefilled Syringe Considerations
PFS formats introduce considerations such as extractables and leachables, plunger glide, silicone oil distribution, viscosity behavior during injection, and needle or tip selection. These factors influence both formulation choices and assembly strategies.
Early Integration with Component Experts
Novocol Pharma’s close relationships with major device and component suppliers help ensure that material choices are assessed early and with realistic downstream implications in mind.
A Development Process Anchored in Technical Leadership
Novocol Pharma’s formulation and development work is shaped by a multidisciplinary team that includes product development scientists, analytical specialists, engineers, and technical PMs. Instead of operating in silos, these groups collaborate from the beginning to ensure that formulation, testing, equipment, and operational constraints evolve together rather than sequentially.
Highlights of this integrated model include:
- Early compatibility and stability strategy informed by analytical and device insights
- Fit-for-purpose equipment specification (mixing tanks, single-use or stainless, filtration assemblies) based on process needs
- Collaboration with vendors to accelerate equipment concepting and procurement, enabled by strong supplier relationships
- Characterization studies and development activities (mixing ranges, pH behavior, viscosity evaluation, shear sensitivity, thermal stability) rooted in real operational context
- Transfer-ready procedures developed in sync with manufacturing teams
- Engineering and validation team collaboration during scale-up to ensure process reproducibility and line readiness
This approach helps our customers avoid the disconnect that often arises when formulation work, analytical work, and fill/finish planning happen in separate streams.
Formulation and Development Capabilities
Novocol Pharma’s development offering supports the full continuum of early-phase activities needed to prepare a product for aseptic filling, assembly, and scale-up.
Technologies and Facilities That Support Development Success
Formulation and development activities at Novocol Pharma are supported by a mature suite of technologies, operational infrastructure, and testing environments. These assets help teams characterize formulation behavior, assess manufacturability, and prepare for smooth transition into GMP operations.
Supporting technologies and facility strengths include:
- Multi-line cartridge and flexible PFS filling capability
- In-house analytical support for method development and stability studies
- Test environments for device and formulation interaction studies
- Equipment options that include both single-use and stainless-steel systems, based on program needs
- GMP operations with a strong inspection history
- Cleanroom and controlled environments that support characterization, compatibility evaluations, and development activities