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.
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.
Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
As innovations in medicine enable the introduction of new therapies for the treatment of chronic conditions impacting patients around the globe, safely containing and delivering these therapies is top of mind for both pharmaceutical companies and their manufacturing partners. By partnering with a device or delivery system manufacturer early and often in the drug development journey, pharmaceutical manufacturers can not only move to market with an approved, commercially viable drug delivery system, but also gain valuable insight into the drug product along the way.
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.
To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.
Ensuring that the cells do not have too much or too little, enables them to grow fast and maximize the product secretion. Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.
Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific HyPerforma S.U.B.s have revealed the potential for a three- to four-fold improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.
The Jet Feeder is a multi purpose system for feeding powders into liquid and for low shear mixing. It is the perfect unit to use on those products that are sensitive to shear. ILC Dover completed a successful test at a pharmaceutical facility for mixing starch into solution for a tableting process. The system is cGMP, easy to clean or CIP, and will work in single pass processes or recirculating processes. JetSolutions is an ILC Dover company and is the manufacturer of the Jet Feeder.
Capsugel® Vcaps® Enteric Capsules is a capsule technology that simplifies drug enteric delivery implementation from early-stage development to commercial manufacturing. The pharmaceutical grades of cellulosic derivatives used in Vcaps® Enteric capsules have extensive market precedence for use in providing enteric protection. Capsugel® Vcaps® Enteric capsules have been evaluated in-vitro and in-vivo across a number of compounds, which has proven full compliance with relevant European, Japanese and US Pharmacopeia monographs.
The Hitachi Koki model himac CR22N High-Speed Refrigerated Centrifuge offers reliable performance with a maximum RCF of 55,200xg and capacity of 6L for bottles, tubes, or microplates. Patented features such as the Automatic Rotor Identification and Rotor Cover Detector make the CR22N the ideal separation tool for multiple research applications involving DNA, RNA, viruses, proteins, and more.
The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.
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).
NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.
NuAire is pleased to partner with the reputable brand Hitachi Koki to offer our customers sales and support of table top and floor standing Mirco Ultracentrifuges in the North American market.
Nanoparticle size analyzer with zeta potential measurements.
The Zetasizer Pro is a robust and versatile system for the measurement of particle and molecular size and electrophoretic mobility and zeta potential of nanoparticles.
