Formulation Development
Formulation development of a new drug product at CARBOGEN AMCIS is designed with great attention to detail, to fulfill the specific requirements of pharmaceutical products, diluents, and applications throughout the preclinical, clinical, and commercial phases.
Our commitment to quality extends to rigorous stability testing and monitoring of the formulation throughout the manufacturing process, storage, and clinical use. Because we understand the complexities of drug product development, we also undertake comprehensive compatibility studies to assess the interaction of the formulation with a wide range of contact materials. This approach is essential when working with pharmaceutical compounds where precision and safety are paramount.
With CARBOGEN AMCIS, you gain a partner who is dedicated to innovation in formulation development, ensuring that your pharmaceutical products are developed to the highest standards.
Process Development
CARBOGEN AMCIS leads the field in process development services, with specific expertise in both liquid and lyophilized drug products. Our customized and QbD centered approach guarantees that your product – whether in liquid injectable drug product dosage form or requiring lyophilization– will receive a development process that is tailored to your specific needs.
Our particular excellence in the optimization of the lyophilization cycle is a key step in securing the high quality as well as the required stability. Moreover, understanding that the primary packaging is an integral part of the shelf life of the drug product we provide a complete service in the selection of primary packaging components. From extensive compatibility studies to stability testing that ensures that the formulation in the selected primary packaging component meets the highest quality and safety standards to meticulous sterilizing filter selection and validation, all are an essential part of our commitment to meeting the most stringent regulatory standards.
CARBOGEN AMCIS is your partner in process development excellence, bringing you the most advanced and reliable services in drug product development.
Analytical Services
At CARBOGEN AMCIS we provide a variety of analytical services that play a key role in advancing drug product development with precision and attention to detail. Our expertise includes implementing and optimizing methods to ensure they are robust, reliable and customized for each projects specific requirements.
At CARBOGEN AMCIS we provide a variety of analytical services that play a key role in advancing drug product development with precision and attention to detail. Our expertise includes implementing and optimizing methods to ensure they are robust, reliable and customized for each projects specific requirements.
Equipped with state-of-the-art analytical technology, including:
- uPLCs, HPLCs with UV & DAD detectors
- pH-meter/Osmometer/Oxymeter
- Nano Sizer – MALVERN
- UV spectrometer
- Viscosimeter / Densimeter
- Safety cabinet / Incubators
CARBOGEN AMCIS is set to meet the most demanding requirements in drug product analysis.
Lyophilization Cycle Optimization
At CARBOGEN AMCIS, we specialize in lyophilization cycle optimization, a critical service in pharmaceutical development, which requires specialized knowledge. Our team of experts is dedicated to streamlining the lyophilization cycle to ensure the highest quality and stability of your drug products.
Through our advanced optimization techniques, we fine-tune each phase of the lyophilization cycle, from initial freezing to final drying, ensuring optimal moisture content and product quality. Recognizing the importance of scalability, our services can seamlessly bridge the gap between R&D and commercial production. We excel at translating small-scale lyophilization successes to larger, commercial-scale operations, maintaining product consistency and quality throughout the scale-up process.
With CARBOGEN AMCIS, you gain a partner equipped with the latest technology and expertise, committed to bringing your lyophilized products from the lab bench to the clinic with precision and efficiency.
Highy Potent
CARBOGEN AMCIS is at the forefront of formulation and process development for high potency compounds and specializes in handling complex (bio)pharmaceutical compounds and small molecules such as Antibody Drug Conjugates (ADCs) and others classified up to Occupational Exposure Band (OEB) 5.
Our expertise in the manufacture of highly potent compounds is underpinned by our rigorous internal categorization system, which ensures the highest levels of safety and precision in handling.
Our state-of-the-art facilities are designed to provide full containment throughout the development, analytical and manufacturing phases to ensure the highest standards of safety and quality.
This full containment is critical for handling compounds up to Occupational Exposure Band (OEB) 5, the highest level of potency. It demonstrates our dedication to handling the most challenging and potent compounds with superior expertise.
At CARBOGEN AMCIS, we combine our vast experience with state-of-the-art technology to provide superior services in the development of drug products and the formulation of high potency active pharmaceutical ingredients
Non-GMP Manufacturing
Non-GMP manufacturing is an integral part of drug development services, providing a flexible, cost-effective, and efficient pathway for early-stage drug development prior to transitioning to GMP-compliant manufacturing.
At CARBOGEN AMCIS, our non-GMP manufacturing services are specifically designed to support the early stages of drug development and formulation. We bring precision and reliability to your development journey by specializing in the production of non-GMP batches for preclinical studies. Using advanced isolator technology, we maintain the low bioburden conditions essential for producing high-quality, contamination-free batches. Providing critical stability data to support the transition to GMP manufacturing, our services are an integral part of the scale-up process.
As a fill and finish CDMO, we provide complete full-service in sterile fill-finish manufacturing for liquid and lyophilized dosage forms that are critical to the final stages of drug product manufacturing.
For more information download our Drug Products brochure.
