As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
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.
A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.
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. Don't be unprepared from the outset of your search.
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.
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.
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.
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.
With nearly 30 years of providing cGMP CMC analytical services to the pharmaceutical, biotechnology and medical device industries, Nitto Avecia Pharma Services has a proven track record of providing testing and phase-appropriate validation services for nearly all dosage forms from pre-clinical through post-mark life cycle management (including potent and controlled substances).
Ibex Solutions, from Lonza, consist of three innovative CDMO offerings that span the complete product lifecycle of a biopharmaceutical – from preclinical to commercial stages, from drug substance to drug product, all in one location.
Nitto Avecia Pharma Services is a premier contract development and manufacturing organization offering a comprehensive range of cGMP services including formulation development, parenteral manufacturing, and a complete package of CMC analytical services for small to large molecules and nearly all dosage forms
