In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.
The properties of the particles that make up a pharmaceutical powder directly affect its behavior, a classic example being that finer particles are usually associated with poor flowability. However, so too do other ‘system’ variables, such as the degree of aeration or consolidation. The analytical toolkit required for the knowledge-led control of formulation properties therefore necessarily extends from particle characterization through to bulk powder testing techniques. Particle characteristics are the levers manipulated to meet performance targets, but bulk powder properties often define some of these targets. Marrying the results from both types of analysis is often the key to efficient progress.
The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Vaccines are absolutely crucial for maintaining global health, but are a challenge to develop and manufacture. How can businesses ensure profitability while providing low prices for developing countries?
Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation. Read about the options provided by wearable technology offers new alternatives that were not previously possible due to historically binding parameters for formulators.
This video highlights Almac’s world-class Charnwood campus facilities which currently have over 1,500m2 of readily available GMP floor space that can be customized to suit the specific needs of their client partners.
Lonza is committed to working closely with our customers to provide cost-effective and time-efficient solutions for their development and manufacturing needs. Read more about our complete service including process development, GMP manufacturing of drug substances, aseptic fill/finish of drug product, product release testing, regulatory support and cGMP storage and distribution.
The Xcelodose® S is a powder micro-dosing system and is a part of the Lonza Engine™ equipment portfolio, which was created to support bioavailability enhancement, encapsulation and early-phase clinical development technologies. There are two models available – the Xcelodose® 120S (semi-automated), and the Xcelodose® 600S (automated). To learn more about the capabilities and specifications, download the brochure.
The benefits of hot-melt extrusion (HME) - a leading approach based on mature process understanding,
small process footprint, continuous operation and readily scalable.
NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.
NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).