Flexible Single-Use Assemblies, Built Around Your Process
High Purity New England (HPNE) specialises in the design and manufacture of custom single-use assemblies for bioprocessing applications.
Through their HPConnexx platform, assemblies are designed around your exact process requirements, not forced into a predefined catalogue. This allows teams to move quickly from concept to a working solution, while maintaining the quality, traceability and documentation expected for GMP use.
We work closely with HPNE to support UK customers with design, specification, and ongoing supply.
What does HPNE Offer?
Custom Single-Use Assemblies (HPConnexx)
HPConnexx is HPNE’s core offering. It enables rapid design and manufacture of fully customised assemblies, including:
- Fluid transfer manifolds
Sampling systems - Filtration assemblies
- Bottle and bag assemblies
- Tubing and connector kits
- Closed processing solutions
Assemblies can be built using a wide range of industry-standard components (e.g. CPC AseptiQuik, luer, MPC, sanitary connections) and tubing types to suit your process.
The focus is simple: build exactly what your process needs, with no unnecessary compromise.
Rapid Design → Secure Supply
A key advantage of HPNE is the ability to move quickly in early-stage development:
Concept → design → pricing
Typically within ~1–2 weeks
Prototypes can be built and tested early in process development
Designs can then be locked and transitioned into GMP supply.
This helps reduce delays between process development and manufacturing readiness.
GMP Manufacturing & Documentation
For production assemblies, HPNE provide:
- Cleanroom manufacturing
- Gamma irradiation (standard or expedited)
- Full quality documentation, including:
- Certificate of Conformance
- Gamma dose verification
- Material traceability
- USP Class VI / ADCF, where applicable
SAL*
Assemblies are typically supplied double-bagged (with options for additional packaging where required)
Supply Chain Support
HPNE’s model is built around flexibility and supply security:
- Ability to source across multiple component manufacturers
- Support for long-lead or constrained components
- Options to pre-procure materials to reduce risk
- Structured lead times for repeatable supply
- For customers scaling up or moving toward GMP manufacture, this can significantly reduce supply uncertainty.
Where does HPNE fit?
HPNE assemblies are typically used across:
- Cell and gene therapy
- Vaccine and viral vector production
- mAb and protein manufacturing
- Process development, MSAT & GMP environments
They are particularly valuable where:
- Standard assemblies do not quite fit the process
- Design flexibility is required
- Speed of iteration matters
- Supply chain reliability is critical
As the UK partner for HPNE, we provide:
Local support throughout the design, development and supply process. From early consultation and concept refinement through to drawing iterations, engineering communication, order management and process integration, we help ensure each assembly is not only supplied, but properly implemented in practice.
Read the latest HPNE publications
High Purity New England products
Single-use Assemblies
HPNE HPConnexx Custom Single-Use Assemblies
