Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.
The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production. Visit Website
EdgeOne Medical is a leading global Contract Device Development Organization, serving as the trusted testing and device development partner for more than half of the top 20 global pharmaceutical companies. As experts in compliant device development from benchtop to commercialization, we leverage our extensive industry knowledge, advanced in-house laboratory, and ISO 13485 certified Quality Management System to accelerate and derisk the development journey for our clients. EdgeOne Medical’s ability to get it “Right First Time” has made us the preferred partner for many key players in emerging pharma and big pharma. Our track record also includes supporting the combination product device development for several newly acquired emerging pharmaceutical companies representing the largest deals in the last year. Visit Website
Victrex is a supplier of high-performance polymers, focusing on the aerospace, automotive, energy, electronics, manufacturing & engineering, and medical markets. Victrex PEEK and PAEK polymers have multiple applications in drug delivery, including for devices such as inhalers and wearable injectors. Visit Website
Suttons Creek is pharma’s device team. Any company adopting combination product technology needs an experienced combination products team working alongside their drug team, including specialists in areas like quality, regulatory, vendor selection and management, systems engineering, risk management, clinical development, and commercialization. Suttons Creek has over 650 years of combined experience and 120+ combination product projects under its belt, with a talent pool of subject matter experts that specialize in all aspects of combination product development from strategic planning through device development to launch and postmarket activities. We can be any or all things combination product to a client, consulting hour by hour or engaging in strategic partnerships to achieve milestones, lift roadblocks, fill knowledge gaps, and drive program success. Visit Website
Catalent Inhalation has the capabilities, expertise and state-of-the-art facilities to expedite product development, from concept and feasibility studies through commercial manufacture and release testing. With over 30 years of inhalation product experience, Catalent can handle the most complex projects and help bring your therapy to market, faster. Whether a single service or a comprehensive development package is required, Catalent offers end-to-end solutions for pulmonary and nasal delivery, with development and manufacturing capabilities for Dry Powder Inhalers, unit-dose, bi-dose and multi-dose nasal products. In addition, Catalent provides comprehensive analytical, bioanalytical and clinical supply services to support your molecule from development through product launch and beyond. Visit Website
INKE is a developer and manufacturer of the highest quality active pharmaceutical ingredients (APIs) with complex synthesis processes, mainly for use in respiratory therapies. Visit Website
Our scientists provide development support for a wide range of pharmaceutical dosage forms with specialist expertise in OINDP development with integrated formulation and testing services for both small molecules and biologics. Our teams carry out early-stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing, and device selection support. For inhaled biologic development, comprehensive protein characterisation services supported by forced degradation and stability monitoring for the protein’s structure and bioactivity throughout formulation and storage can also be provided. Interaction with the device and closure systems are evaluated through comprehensive extractable and leachable testing and toxicological assessments.
With 30 years of experience in supporting our clients’ inhaled and nasal product developments, we deliver world-class support to help you meet the challenges of your demanding development programs. The Intertek Melbourn laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections. Visit Website
MUNIT is a company that specializes in the micronization of various types of pharmaceutical ingredients and compounds such as active pharmaceutical ingredients (APIs), high potent APIs, cytotoxic and cytostatic compounds, inhalation products, steroids, R&D compounds, and generics. The company is a combination of two affiliates, Jetpharma SA in Switzerland and Microchem Srl in Italy, with over 40 years of experience in the micronization sector.
MUNIT offers a range of services, including Jet, Pin, and Hammer milling, Cryogenic Micronization, Co-micronization, Sieving, Blending, De-Lumping, Technical trials, DoE Studies, Process development, and validation, QbD, and PSD analysis. MUNIT is your access point to Jetpharma’s and Microchem’s services, providing technical and commercial expertise in the micronization industry. Visit Website
14-15 November, 2024 | Manhattan, New York, USA
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