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(FDA) oversees approval of biosimilar interchangeability designations and in January released its long-awaited draft guidance detailing the agency's expectations for demonstrating such interchangeability.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.
Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.
Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.
The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.
Alvotech's facility features a high-yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes,and end-to-end upstream/downstream automation.
Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.
