How do biopharmaceutical companies handle CMO and supplier relationships that stem from M&A activity? Who better to ask than Shire? The folks there know M&A and outsourcing as well as anyone in the global biopharma industry today.
After giving a recent course on reacting to human error, one of the attendees sent me a variety of questions about how to apply the human performance models we discussed in FDA-regulated environments.
Last month, FDA issued a Warning Letter to Polydrug Laboratories of Maharashtra, India, stemming from an inspection in March 2015. Certainly, Polydrug has conducted extensive negotiation with the agency since the inspection, and is now feeling the impact of the unresolved deficiencies. However, closer review of the text of the Warning Letter reveals Polydrug was placed on Import Alert in September, 2015, inflicting immediate restrictions on Polydrug’s US revenue.
Single-use technology has been used in bioprocessing for over 20 years. Once a niche technology to replace plastic or glass carboys it has now developed to the extent that it is commonly used throughout the industrial-scale manufacture of biologics (Heaven, 2016).
Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.
The largest country in the world, Russia is bigger than Pluto at 16.6million km2, and is separated from the USA by less than 4 km. Still nominally at war since 1945 with Japan over the Kuril Islands, it has 20% of the world’s unfrozen fresh water in a single lake, Lake Baikal. It spans nine time zones, has 28 official languages and has the world’s longest railway. The first Russian child to receive the vaccine against smallpox was called “Vaccinov,” given a pension, and observed throughout his life.
Better local resources around the world and more sophisticated technology are changing the dynamics of logistics services.
Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
Sam Herbert, chief operating officer, World Courier, a part of AmerisourceBergen Pharmaceutical manufacturers face a multitude of challenges as they work to bring new products to market.
The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world. With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.
There is growing interest among consumers in verifying that the dietary supplements they take are safe and efficacious. Media outlets have questioned whether supplements truly are delivering the ingredients on the label. By Joanna Cosgrove
Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.
Creating a successful drug delivery device requires the seamless integration of the biological or pharmaceutical regulatory requirements with the device regulatory requirements. There are several factors that need to be considered in order to do this, all while ensuring the patient is kept at the center of the design.
In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.
Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.
Phillips-Medisize is a global contract manufacturer with 1.7 million square feet of manufacturing space designed to meet demands associated with drug delivery devices and pharmaceutical packaging needs. Our dedicated specialists understand the complexities of product development, and offer a full range of product development services through commercialization with a constant focus on quality.
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies. Althea has the capacity to support early-stage clinical requirements through commercial manufacturing.
WellSpring provides peace of mind to pharmaceutical companies for their contract manufacturing and packaging needs. When you work with WellSpring, you'll have a whole team of professionals backing your project. Our team will oversee the entire operation; while a project manager will help you plan all stages. You'll also have a dedicated technical team to manage all aspects of the project. All this at one convenient location, offering everything from clinical to commercial manufacturing, packaging and analytical testing services for virtually all non-sterile dosage form products including, tablets, capsules, creams, lotions, ointments, gels and oral liquids.
Capsugel offers capsules for the pharmaceutical and dietary supplement industries in multiple polymers — gelatin, HPMC, and pullulan.
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