ARTICLES BY TRISHA GLADD
What Is the Industry Underestimating About An ADC Supply Chain? – Part 2
In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.
What Is the Industry Underestimating About An ADC Supply Chain? – Part 1
Because not all companies can create all three components of an antibody drug conjugate (ADC) in-house, the next option is to work with a partner. In doing so, you should anticipate several challenges along the way. The question is—will you be surprised to find out what they are?
Is The Single-Use Standardization Debate Slowing Down Adoption?
Without single-use standardization, the customization required to build a single-use facility may prevent a full-scale adoption of single-use technology. So how do we move forward? Maybe, by taking a look back.
How Can Cell Culture Conditions Affect Biologic Product Quality?
When it comes to the development of new biotherapeutics, particularly glycoproteins and other post-translationally modified proteins, it is important that such modifications do not alter the activity, pharmacokinetics, or stability of a protein nor provoke immunogenicity in the patient. By understanding what factors can change a protein, as well as the steps to detect and analyze those changes, the risk of doing so is reduced and the efficacy and safety of the drug is preserved.
Merck Champions Single-Use By Addressing Emotion Vs. Science
Lowering the cost of medication is the key to the US gaining a stronghold on the global pharmaceutical market. As anyone knows, in order to lower the cost of medication, the cost of manufacturing will need to be lowered as well. According to Chris Smalley, Ph.D., director of validation compliance at Merck, single-use technology (SUT) could be the hero.
Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method?
As we move into 2015, cell therapy as a viable and profitable market is becoming more of a reality, especially with the increased focus on unmet medical needs offering the potential for small companies to find their niche in the industry. However, one of the challenges with working with cells, at both the research and clinical level, is the issue of variability that can occur during the thawing of cryopreserved cells. Overcoming this challenge would address issues with current methods, such as viability, contamination, and inconsistent results.
Merck Uses Automation And Disposables To Drive Upstream Process Development
Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become. Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen
Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency
When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.
Bioprocessing Technology Forum Offers Valuable Insight Into Industry Advancements
On October 1st and 2nd, the Upstream/Downstream Technology Forum, hosted by Sartorius, was held in Cambridge, MA. Industry leaders were given the opportunity at this event to cover topics focused on technological innovations in upstream and downstream bioprocessing, which allowed registered participants to come away with an increased awareness of the latest technical applications as well as upcoming new applications for existing technologies.
USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
In September, the US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.