When you need customised and scalable filling, packaging and logistics solutions for reservoir and single-dose dry powder inhalation (DPI) devices, Experic offers an experienced team and state-of-the-art capabilities.
Experic is a contract manufacturing organization (CMO) and pharmaceutical supply services company, which supports all stages of a product’s lifecycle from clinical to commercial scale.
The company’s manufacturing services include a range of dosing and packaging formats, including powder and pellet dosing, capsule filling, pen assemblies and auto-injectors.
Experic manages worldwide delivery of high-quality products, offering unparalleled expertise and customer service, using cutting-edge Harro Höfliger equipment in its state-of-the-art Class A good manufacturing practice (GMP) facility and built-to-suit suites.
Smart solutions for clinical-scale manufacturing
To address the critical properties of each formulation, Experic offers a variety of clinical scale development and manufacturing services.
The company’s pharmaceutical filling techniques, with flexible check-weighing options, include capsule-in-capsule, tablets and micro-tablets, powder and pellets, as well as combination filling.
Experic can fill various types of receptacles with pellets and powder and offers expert low-dose powder filling capabilities for micronized and spray-dried formulations for dry powder inhalation (DPI). In addition, Experic’s automated assembly and labelling capabilities for pens and auto-injectors allows for the efficient manufacture of these devices at clinical scale.
Pharmaceutical supply services and clinical packaging and logistics
Experic works alongside its customers to develop strategies for enhancing packaging and logistics programs across the globe for clinical trial supplies.
Its broad capabilities comprise primary and secondary packaging, as well as comprehensive services for kitting, labelling and global logistics. Meticulous quality control oversight guarantees regulatory compliance while meeting the specific aims of each project.
The company’s primary packaging options comprise cold and thermo-formed blisters, pouches, bottles, and innovative medical devices. Secondary packaging capabilities cover kit assembly, blister card sealing, and medical device packaging and labelling, augmented by binding, inspection, label design, print management, and commercial drug sourcing.
Product storage environments include controlled room temperature (15°C-25°C), walk-in refrigerated storage (2°C-8°C), frozen material storage (-20°C and -80°C), and a controlled substance vault (CII – V).
Experic coordinates worldwide logistics and distribution from shipments to patients and sites to reconciliation, returns, and destruction, proactively communicating the status of projects and inventories to its customers.
Scalable commercial manufacturing services
Experic has a unique partnership with Harro Höfliger, whose premier filling equipment allows for comprehensive process scalability as products progress from clinical development to commercial production.
This characteristic reduces scale-up risk and is supported by Experic’s scalable solutions for distribution, packaging and storage, while the partnership affords clients accelerated access to standard and custom equipment configurations.
For larger scale or dedicated configurations, the company offers custom-built suites in its 40,000ft² space with priority access to design, production and commissioning support for end-to-end expansions of approximately three to six months.
Proactive project management
Experic’s team of industry experts works closely with each customer to successfully execute every project, providing project governance and oversight to accomplish the customers’ objectives.
The company assigns a designated project manager to each account as a single point of contact. This individual handles all program or project activities, acts as the customer’s personal advocate with internal Experic departments, and proactively contributes recommendations to deliver ideal solutions for logistics, packaging, labelling and regulatory compliance.
In addition, Experic project managers share all project-related documentation, including a custom project plan, oversee third-party vendors, and coordinate all project communications to meet the customer’s requirements.
Experic ensures it maintains the highest level of quality and compliance, responsibly conducting business, and using industry best practices for business ethics, quality systems, and regulatory compliance.
The Experic quality management system incorporates a broad and flexible strategy to maintain compliance and inspection readiness. The quality team manages policies and standard operating procedures (SOPs) across the business, guaranteeing continuity and adherence to critical client demands and regulatory requirements.
A small-sized pharmaceutical company had worked with a variety of other contract manufacturing organizations (CMOs) and had no success achieving the necessary product yields to advance the development of their highly cohesive product formulation.
As a combination drug product development project moves from the laboratory into production to generate supplies for clinical research, it is necessary to involve multiple functions including manufacturing, engineering and analytical support to make and release these materials. This is especially true for inhalation and nasally administered powders. The complexity of transferring a drug product is increased when the product involves a drug-device combination.
EVERSANA™ and Experic are pleased to announce that they will be partnering to aid life sciences companies in optimising clinical development, manufacturing, launch planning and commercialisation efforts.