In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study.
Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.
With the expanding biologics market comes some considerable challenges for drug manufacturers due to the fragile nature and instability of these large, complex molecules. As compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.
Companies in need of aseptic syringe and vial fill and finish services may find themselves unprepared for selecting the right components and component supplier to meet the needs of their product. A critical process, which can be overlooked or underestimated, thereby jeopardizing clinical or commercial programs.
Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.
The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses. Pharmaceutical companies looking to add biologics to their pipelines must come up with innovative ways to approach drug development and cut the high costs associated with it. In this white paper, we review how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.
Current trends in drug development point toward a growing number of therapies that are targeting smaller patient populations. As the batch sizes required to manufacture clinical and commercial supply of these therapies are smaller than in the days of blockbuster medicines, the equipment and processes for manufacturing have had to change as well, creating challenges for smaller pharmaceutical companies. Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and ultimately help the smaller patient populations who need targeted therapies.
With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.
Lonza’s global R&D center for mammalian cell processes is based in Slough, UK alongside a custom manufacturing facility. Lonza undertakes highly specialized development and manufacturing services for the pharmaceutical and biotechnology industries. Read more about Lonza’s complete range of R&D Services and an array of technologies and skills to best match their customers’ requirements for all stages of product development.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
OnTheGoSM is a PDMA-compliant suite of mobile/web apps that optimize sales representative productivity and enhance practitioner convenience and service. They complement the Patheon, by Thermo Fisher Scientific specialty logistics sample distribution service offering by providing Sales Representatives and Managers with enhanced capabilities.
Providing analytical chemistry services since 1988, Nitto Avecia Pharma Services has established streamlined processes supported by experienced staff to provide reliable, expedited testing for nearly all drug substances, products, and components.