Capabilities
BUILT AROUND YOUR PROGRAM
For Life Sciences, Combination and Drug Product Manufacturing and Lyophilization
Our capabilities support programs across development, transfer, validation, launch, and ongoing commercial supply.
Connected Processes >
We do not approach these as disconnected services. Each capability is coordinated around the broader needs of the program, with the objective of protecting the product, the timeline, and the client’s commercial goals.
Our Capabilities Include
- Manufacturing and Engineering support for scale up
- Technical transfer and scale-up
- Simple and complex formulations
- Reagent and solution preparation
- Simple and complex filling
- Lyophilization
- Drug device combination product formulation, filling, assembly and packaging
- Labeling, Kitting and Packaging
- Equipment Qualification
- Process validation and Process performance qualification
- Quality Control
- Material procurement and supply chain management
- Commercial manufacturing and recurring supply
A Focused Partner for Complex Products
Aluris is not trying to be everything to everyone.
Our focus is supporting programs that require careful coordination across manufacturing, quality, engineering, supply chain, program, and commercial operations.
This includes life science and in vitro diagnostic products, drug-device combination, drug and lyophilised products, and other programs where multiple technical and regulatory disciplines intersect. That complexity is not something we avoid, it is where our experience creates value.
Offering >
Manufacturing Scale
There is no minimum scale or batch size requirements at Aluris – allowing your program to grow at its own pace.
Lyophilization Capacity
We have standardized our lyophilizer equipment models to enable rapid changes in scale and provide redundancy – no matter what product format type. Our lyophilization cleanrooms are designed and engineered to maximize production.
Fill and Finish Equipment
Aluris utilizes single use disposable technology to prevent cross-contamination. Manual, semi-automated and automated equipment supports small to large batch sizes of multiple primary container types including bottles, cartridges, syringes, tubes, vials and custom parts.
Cleanroom and Environmental Controls
Aluris’ ISO 7 and 8 cleanrooms are controlled, certified and routinely tested through our environmental monitoring program. Production requiring low relative humidity is supported in specially designed cleanrooms.
Analytical and Testing Equipment
Critical instrumentation and qualified third party laboratories enable Aluris to support raw material programs, in-process and final release testing. Click here for additional details.
Storage Conditions Available
Temperature controlled and monitored storage areas and chambers are available for in-process and finished goods storage – ambient, refrigerated, frozen and ultra-cold.
FAQs
Q. What is a combination product and how is it regulated?
A. A combination product is a product composed of two or more regulated components — a drug and a device, a biologic and a device, or a drug and a biologic — that are physically, chemically, or otherwise combined into a single entity. In the US they are regulated by the FDA under 21 CFR Part 3, with the primary regulatory centre determined by the product’s primary mode of action.
Q. What types of combination products does Aluris manufacture?
A. To be completed by Aluris — specific formats and assembly types to be confirmed.
Q. How do you manage the regulatory complexity of combination products?
A. To be completed by Aluris — specific regulatory frameworks and submission experience to be confirmed.
Q. What is the difference between a drug-device combination product and a medical device with drug coating?
A. A drug-device combination product is regulated based on its primary mode of action, whereas a device with a drug coating may be classified differently depending on whether the drug component has an independent effect. Our regulatory team can support you in determining the correct classification for your product.
Q. Can Aluris support both the drug and device constituent parts, or do I need separate suppliers?
A. To be completed by Aluris — clarity on whether they manufacture or source device components, and how they coordinate constituent part supply.
Q. How do you handle extractables and leachables testing for combination products?
A. To be completed by Aluris — specific approach to E&L testing and whether this is conducted in-house or through qualified testing partners.
Q. Do you support human factors and usability studies for combination products?
A. To be completed by Aluris — confirmation of whether human factors support is offered or coordinated.
Q. What stage of development can you engage from?
A. To be completed by Aluris — earliest stage of program they can productively engage with.
Q. How does your quality system address both drug cGMP and device QSR requirements simultaneously?
A. To be completed by Aluris — specific QMS structure and dual-compliance approach.
Q. What does the technical transfer process look like for a combination product?
A. Combination product transfers are more complex than standard drug or device transfers because they require simultaneous coordination of drug process, device specifications, assembly processes, interface compatibility, and dual regulatory documentation. Aluris’s approach begins with a comprehensive gap assessment across both constituent parts before any transfer activity begins.
Q. Can you support international regulatory submissions for combination products?
A. To be completed by Aluris — confirmation of markets and submission types supported beyond FDA.