State lawmakers continue to spearhead legislative boundaries to automatic biosimilar substitution at a rapid clip across the nation, with 33 states and Puerto Rico having taken action and with bills pending in eight more states. The U.S. Food and Drug Administration (FDA) oversees approval of biosimilar interchangeability designations and in January released its long-awaited draft guidance detailing the agency's expectations for demonstrating such interchangeability. However, achieving “interchangeable” status (i.e., demonstrating that a biosimilar may be substituted for its reference product under the FDA rules) will only be one step toward attaining product substitution, as overarching control is being assumed by state legislatures.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.
The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.
State lawmakers continue to spearhead legislative boundaries to automatic biosimilar substitution at a rapid clip across the nation, with 33 states and Puerto Rico having taken action and with bills pending in eight more states. The U.S. Food and Drug Administration (FDA) oversees approval of biosimilar interchangeability designations and in January released its long-awaited draft guidance detailing the agency's expectations for demonstrating such interchangeability. However, achieving “interchangeable” status (i.e., demonstrating that a biosimilar may be substituted for its reference product under the FDA rules) will only be one step toward attaining product substitution, as overarching control is being assumed by state legislatures.
Our industry is engaged in the discovery, development, and production of high-quality, safe, and efficacious medicines intended for reducing the suffering and improving the lives of our patients. Ensuring medicinal product quality is our responsibility, and the FDA has written that “quality cannot be tested into products; it should be built in by design.” Many of our medicines are structurally complex or are made via complex processes (which include the use of hazardous materials). So, end-product testing alone is an insufficient measure of product quality, from our patients’ perspectives.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
You are unlikely to create the final model in your first attempt. Use the power of multivariate analysis to select interesting samples based on the instrumental measurements before you put them through the lab.
Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.
The advantages of single-use are well-known — faster, smaller, greener, cheaper, and safer — and increasing numbers of biomanufacturers have sought to reap these benefits, especially as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.
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.
To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.
