In general, can you tell us about the services and expertise Moravek, Inc. brings to the market?
Moravek, Inc. is a leading provider of custom radiolabeled, stable labeled and non-labeled compounds and specializes in the manufacture and release of carbon-14 labeled APIs under cGMP conditions in support of clinical trials worldwide.
Our company has been supplying the highest quality custom synthesized compounds to research organizations, pharmaceutical companies and the top CROs for over forty years. Moravek’s team of twelve radiochemists have synthetic expertise that covers an extremely broad range of chemistry techniques and have developed and optimized conditions for thousands of reactions. This exceptionally experienced team makes possible the labeling of specific sites on a molecule in order to optimize pharmacokinetic data, while achieving high overall yield and purity. Projects are carried out with optimal time and cost efficiency in mind. This highly capable radiochemistry team is supported by exceptional Quality Control, Quality Assurance, Logistics, and Project Management specialists.
What specific services or expertise does the company have that sets it apart from its competitors?
Moravek has a 100 % success rate in the production of carbon-14 and tritium labeled APIs for early phase mass balance and microdosing clinical studies. Our company proudly houses the largest capacity and most experienced GMP radiolabeling group in North America with a core of 12 radiochemists, 6 Quality Control staff members and 4 Quality Assurance staff members all supported by renowned logistics and project management specialists.
Custom synthesis of carbon-14 labeled APIs under cGMP conditions is made possible with specialized facilities, equipment and processes including technical batch synthesis, master batch record, method transfer, system suitability, UPLC, HPLC, NMR, MS, ICP/MS, Headspace GC/MS, XRPD analyses and stability studies that can be carried out at 25°C/60% RH, 4°C, -20°C, or -80°C. These services are not only carried out by trained staff utilizing qualified equipment, but the data generated by these instruments is generated and stored in compliance with 21 CFR part 11.
What are 14C or 3H labeled active pharmaceutical ingredients (APIs)? What are they used for?
An API (Active Pharmaceutical Ingredient) is the part of any drug that produces the intended effects. Once an API has been manufactured in its radiolabeled form under cGMP conditions, it can be utilized to enable pharmacokinetic studies of the drug such as an AME (absorption, metabolism, and excretion) studies. Traditional AME studies are carried out utilizing 50–100 microcurie (μCi) per dose. Another option is utilizing the radiolabeled API on a nanotracer or microdose scale for studies using <1 microcurie (μCi) per dose.
Can you provide us with a detailed explanation of the specialized services, technology and expertise you have to properly and safely handle, analyze, and manufacture these specific APIs?
Moravek’s fully trained and qualified custom radiosynthesis, QA and QC groups will manufacture and release your API in accordance with cGMP guidelines. The documentation provided throughout the duration of our campaigns has been accepted by 100% of the regulatory bodies in all countries where Moravek-produced radiolabeled APIs are being used in support of our Client’s clinical trials. Moravek’s refined and expanded facilities now include five certified Class 7 clean environments, more than 50 fume hoods and over 25 qualified analytical instruments including HPLC, UPLC, LC-MS, ICP-MS, NMR, GC-headspace, XRPD, PSD, and KF to name a few. The scale of Moravek’s operations and expertise of our staff enables the entire process, from method transfer, to batch record preparation, radiosynthesis, purification, release testing, stability analysis, storage, shipping, tracking, etc. to be predictably and professionally carried out the most timely and cost-efficient manner.
What is the overall vision/direction the company has – and how will the company apply this vision to its current and future clients?
Moravek’s direction is guided by continuously monitoring the industry’s best practices and implementing suggestions provided to us by our clients and auditors. Staying in touch with the ever evolving landscape and Moravek’s unrelenting desire to provide our client’s with the absolute best service and products possible is the overall vision of Moravek.
Looking ahead can you tell us about any future service additions, expansions, etc.? What are your goals for the company in the near future?
Moravek is committed to aggressively adding capacity and upgrading systems and technology to allow us to continue to outperform our competitors and provide out client’s with the highest quality products, customer services and more rapid GMP campaign completion. The additional of staff, facilities, equipment, data acquisition and storage are an ongoing part of meeting our customers’ needs for high quality labeled compounds in time to be utilized on their study date. Some examples of Moravek’s continuous improvement process include the installation of a facility-wide 500kW backup power solution and the continuous effort to meet the challenges of 21 CFR part 11 compliance. In the coming years we hope to continue to expand our analytical capabilities and provide GMP services to more clients in need to material for later phase clinical trials.