Novo Nordisk Pharmatech A/S and DKSH, have partnered to provide high-quality cGMP quaternary ammonium compounds in twelve countries across Asia Pacific.
Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global biopharmaceutical, pharmaceutical, and biopharmaceutical sectors, has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines.
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
The field of (bio)pharmaceutical research is booming. Increasingly more innovative therapeutics are being developed with the ability to drastically improve the quality of life of millions of patients around the world. Rigorously testing each of these candidate drugs for their safety and efficacy is an essential part of the development process. As the number of clinical trials steadily increases, the search for patients who present a specific medical profile and are willing to participate intensifies.
The autoinjector market is one of the fastest growing markets across almost all pharmaceutical applications. Studies expect a global market volume of approximately USD 2.5 billion by 2020, with pre-filled autoinjectors representing the largest market segment. There are a variety of tests that can be performed on autoinjectors, and these are well-demonstrated by the Zwick product portfolio. The Ulm-based company and specialist in testing systems offers a variety of testing systems that are already being successfully used by multiple pharmaceutical companies.
The foundations for protecting human research subjects come from the
ethical principles surrounding the Belmont report : Respect for persons,
beneficence, and justice. The use of human biospecimens in research
supports these principles with legal and ethical regulations - the most
important of which is permission.(1) This permission may come directly
from the donor or granted by others with authorization to protect the
interests of biospecimen donors.
The Life Sciences cold chain is a seamless and interconnected global network of people, equipment, data and processes that helps to ensure the safety and integrity of our medicines and vaccines. Cold chain logistics spending totaled $13 billion in 2017, an investment designed to protect some $283 billion in Life Sciences cold chain products, growing at 19% annually.1 Sensitech Inc., a part of UTC Climate, Controls & Security, a unit of United Technology Corp., has played an essential part in the Life Sciences cold chain since 1990, providing a comprehensive set of solutions for manufacturers of biologics, prescription pharmaceuticals, clinical trial materials, and over-the-counter drugs. These solutions help to ensure product quality, patient safety, and regulatory compliance while helping to prevent theft and optimizing cold chain performance.
1. Introduction
As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.
CPI to showcase results from BioStreamline project developing novel biotherapeutics
CPI, a UK-based technology innovation centre and a founding member of
the High Value Manufacturing Catapult, announced today that it will host
an event in Darlington, UK on 26 June 2019 to disseminate the results
of the £11.2M BioStreamline project to optimise the development of novel
therapeutics. During the event, the project partners — Lonza Biologics,
UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon),
Alcyomics Ltd and CPI — will showcase the results and discuss the
potential impact on overcoming some of the most significant shortcomings
of the biologics supply chain. More info >>
Smaller, Smarter, Electronic, Connected: The Next Generation of Drug-Delivery Devices
Phillips-Medisize
An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders. Patients wishing to claim more autonomy over their drug regimens, caregivers and medical professionals wanting to more closely monitor drug compliance, health insurance organizations looking to keep costs down, and developers of pharmaceutical products interested in conducting better managed
clinical trials can all benefit from these novel, next-generation technologies.
More info >>
Nordic Life Science Days is the largest Nordic partnering conference for the global Life
Science industry.
Bringing together the best talents in Life Science, offering amazing networking and
partnering opportunities, providing inputs and content on the most recent trends.
Nordic Life Science Days attracts leading decision makers from the Life Science sector,
not only from biotech, pharma and medtech but also from finances, research, policy and
regulatory authorities. More info >>
