Combination Products Manufacturing
Aluris Sciences brings together the disciplines that define successful combination product manufacturing: deep regulatory experience, proven drug product manufacturing capabilities, rigorous quality oversight, and the technical judgment required to integrate them seamlessly.
Life Sciences | Combination Product and Drug Manufacturing | Lyophilization
Our teams understand that combination products cannot be managed as disconnected drug and device workstreams; every material, process, interface, control, and regulatory decision must function as part of a single, compliant manufacturing strategy.
From early development and design transfer through process validation and commercial production, we apply the scientific rigor, documentation discipline, and quality standards our customers have come to expect from us.
The result is more than manufacturing capacity, it is the confidence that your program is being guided by experts who understand the complexity, anticipate the risks, and know what it takes to move a highly technical combination product toward reliable, scalable, and compliant supply.
Our Combination Product Capabilities
Bring your combination product to market with an integrated manufacturing partner that can coordinate complex drug and device requirements. Aluris combines technical expertise, flexible capabilities, and disciplined execution to help reduce handoffs, manage risk, and advance your program efficiently.
- Integrated formulation and filling tailored to your product and scale
- Coordinated drug-device assembly and integration to streamline manufacturing
- Lyophilization options designed to improve product stability and usability
- Component qualification and compatibility assessments that help identify risk early
- Container-closure system evaluation to support product integrity and performance
- Primary and secondary packaging solutions for a range of combination-product formats
- Labeling support aligned with applicable combination-product requirements
- Terminal sterilization coordination through qualified service partners when appropriate
Design Transfer & Technical Transfer for Combination Products
As Aluris also offers Technical Transfer as a core service, this section should specifically address the additional complexity of transferring a combination product, covering:
- Coordination of drug and device transfer packages
- Interface compatibility assessment (drug-device interaction, extractables and leachables)
- Assembly process development and scale-up
- Human factors and usability considerations (where applicable)
- Verification and validation planning specific to combination products
Integrated Quality Systems for Combination Products
- Integrated quality oversight designed to align device requirements under 21 CFR Part 820 with drug requirements under 21 CFR Part 211 and combination-product provisions under 21 CFR Part 4
- Risk management informed by ISO 14971 to help identify, assess, and address product and process risks throughout the program lifecycle
- Coordinated change control across drug and device constituent parts to maintain alignment, traceability, and product quality as your program advances
Combination Product Programs We Support
Advance complex combination products with integrated manufacturing support tailored to your product and delivery system.
- Oral drug-delivery systems
- Drug-eluting implants
- Injection-systems
From Development to Commercial Supply
Move your combination product forward with coordinated support at every stage—from feasibility through reliable commercial supply.
- Feasibility and manufacturability assessment
- Constituent-part qualification for a smoother transition
- Process optimization for scalable manufacturing
- Analytical method development tailored to combination-product testing
- Process, cleaning, equipment, and applicable software validation
- Commercial manufacturing and supply planning for dependable continuity
Why Choose Aluris for Combination Products
Advance complex combination products with one coordinated partner.
- Integrated drug and device expertise under one roof
- Technical transfer specialization applied to complex combination formats
- Quality systems aligned across drug and device requirements
- Coordinated, multidisciplinary program management
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 4, with the primary regulatory centre determined by the product’s primary mode of action.
Q. What types of combination products can Aluris manufacture?
A. Aluris supports a broad range of combination product formats, from implants and prefilled delivery systems to injectors and other integrated drug-device products. Connect with our experts to discuss your product, manufacturing needs, and path forward
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. Can Aluris support both the drug and device constituent parts, or will I need multiple suppliers?
A. Yes. Aluris can support both drug and device constituent parts through a coordinated, end-to-end manufacturing solution. When specialized capabilities are required, we manage qualified partners on your behalf—helping simplify supplier oversight, maintain alignment, and keep your program moving forward.
Q. How does Aluris support extractables and leachables testing for combination products?
A. Aluris coordinates extractables and leachables testing through qualified third-party laboratories with specialized combination-product expertise. We help align testing with your product, materials, and program requirements while providing a streamlined point of contact throughout the process.
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. Aluris can engage early in development and support your program through scale-up and cGMP manufacturing. Involving our team early helps identify risks, align processes with manufacturing requirements, and minimize costly changes as your program advances.
Q. How does Aluris’s quality system support combination product manufacturing?
A. Aluris applies an integrated quality system across device and drug product manufacturing, helping ensure each constituent part—and the finished combination product—is produced in compliance with applicable regulatory requirements. This unified approach supports consistent oversight, coordinated documentation, and quality throughout your program.
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, and interface compatibility. Aluris’s approach begins with a comprehensive gap assessment across both constituent parts before any transfer activity begins.