To navigate supplier and CMO consolidation, Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., offers some advice: Approach your outsourcing relationships like joint ventures. “As you have this greater engagement between two companies,” says Young, “you’re likely to enter an interdependent relationship. Why not acknowledge that rather than try to power-play or position one another?”
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
As pharmaceutical firms work to close the gap between rising R&D costs and profits in an environment of increasing regulatory control and testing, they face the challenge of securing approval and bringing new drugs to market – safely, efficiently and profitably.
This article will not delve into why there have been so many recent data integrity issues within the EU and FDA regulated industries.
The health care marketplace is growing at an ever-increasing pace. It’s projected that total global spending on medicines will increase by 30 percent and top $1.3T by 2018 and that more than 400 Life Sciences products will be launched over the next three years.
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.
The following steps will help guide the process of completing a successful analytical method transfer. By adhering to them, both laboratories can avoid common missteps, thereby removing any barriers to progressing the drug to the next phase in its development and commercialization.
At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes.
Keeping up with regulatory requirements has kept the pharmaceutical industry at the forefront of track-and-trace technologies for years. Now, those regulations are set to get even more stringent on a global scale. With some key deadlines on the horizon, pharmaceutical manufacturers and their OEM suppliers are stepping up their serialization strategies.
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
Today’s medical device and pharma industry assembly concepts can be complex. Here, Bill Welch, chief technology officer, Phillips-Medisize, outlines why, therefore, the company provides a comprehensive assembly concept, tailored to customers’ needs. Scalability begins with early DFM (design for manufacture) / DFA (design for assembly) philosophy integrated into the product development process.
Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. However, the task of selecting the right metrics to incorporate has always been a bit of a challenge as quality can be subjective and hard to measure in a meaningful way.
Orphan drugs, those medications that are typically produced in small quantities for limited patient populations, are growing in importance worldwide. Once largely considered too costly to produce, given the limited number of patients affected by a particular disease, new technology and new breakthroughs in biopharma have changed the landscape, allowing more orphan drugs to be produced than ever before, thus saving countless lives that would otherwise be lost.
Protein-based therapeutics have emerged as a key driver of growth in the pharmaceutical industry. R&D pipelines have filled with biologics and monoclonal antibodies have become the best-selling drugs around the world. Despite the success of this segment, the size and complexity of protein molecules create specific challenges when developing these types of therapeutics.
Capsugel offers capsules for the pharmaceutical and dietary supplement industries in multiple polymers — gelatin, HPMC, and pullulan.
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.
Pfizer CentreSource (PCS) is a leading pharmaceutical contract manufacturer that offers a range of GMP compliant sourcing and outsourcing services to meet your pharmaceutical production requirements.
Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
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.
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.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
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