Our in-house technology platforms shorten the time to GMP production and IND submission
We have established a superior formulation database to shorten the development time
Process CharacterizationMycenax performs process characterization as a critical activity during process development. The generated data allow developing effective process control strategies for process validation and commercial manufacture. Our CapabilitiesApplication of risk assessment methodologies (e.g. FMEA, fish-bone diagram, PHA, decision tree)Design of experiment (DOE) matrix Scale-down model study to provide evidence of Effectiveness of cleaning processViral clearance validationImpurity removal capabilityResin lifecycleMembrane lifecycleMicrobial retention capability
Speeds up the development of the manufacturing process and analytical methods
Self Development MediumMycenax’s Self Development Medium platform uses our proprietary medium which boosts the performance of cell culture processes for CHO cell lines. Technology PlatformSpecifically designed for application with different CHO cell lines (e.g. CHO-S, CHO-DG44, CHO-K1) and various feed supplements to support high cell growth and productivityFlexible use in fed-batch and perfusion processesChemically defined and animal component free mediumMedium components analyzed and monitored by a quality controlSuitable for large-scale GMP production
A stable cell clone with high-level production and low-level insolubility
Project Management and Regulatory SupportMycenax is a reliable partner to you and provides you with all required support and expertise for the successful execution of your project. Project ManagementA project manager is assigned to your project as the main point of contact and will accompany you all the way from the beginning till the end of the project. Our project managers are well trained in the manufacturing technologies as well as regulatory aspects for biopharmaceutical development. Regulatory SupportMycenax has broad regulatory experience and in-depth knowledge of biological drug development for all major global markets. We support you to develop optimal approval strategies and to create approval documents that meet global regulatory requirements. We prepare the complete CMC documentation for applications of clinical trials (IMPD/ IND) or marketing authorization (MAA/ NDA/ BLA). We also advise you in answering regulatory questions and support you to prepare and conduct agency interactions. Data SecurityYour product information and data have the highest value for us. Therefore, Mycenax has implemented a company-wide security system to protect all product-related documents.