Trisha Gladd

ARTICLES BY TRISHA GLADD

• Scale-Up Of Autologous Cell Therapies Realized Through Technological Collaboration

  8/31/2015

  The autologous cell therapy market is experiencing tremendous growth, but under the current system for manufacturing these products, companies struggle to get a return on their investments. However, a recent partnership between Octane and Lonza may finally offer a cost-effective solution to scale-up that could give companies new hope for commercialization.

• Is Sustainability Possible With Single-Use Technology?

  8/12/2015

  At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?

• Federal Ruling Offers Some Regulatory Clarity For Biosimilars

  7/29/2015

  On July 21, 2015, the Federal Circuit reached a momentous decision in the case of Amgen vs. Sandoz. The significance of this ruling goes well beyond the rights of these particular manufacturers, as the decision marks the first step toward clarifying the regulatory path for U.S. biosimilar manufacturers.

• First Commercial-Scale ADC Facility Launches In North America

  7/21/2015

  As of last month, there are a total of 264 antibody drug conjugates (ADCs) in pharma’s pipeline. 161 of those are being developed in North America, making it the continent with the highest number of ADCs in development. Despite this, there is not a company currently offering ADC manufacturing capacity through commercial scale in North America. However, this will no longer be the case by the end of this year.

• What Is the Industry Underestimating About An ADC Supply Chain? – Part 2

  3/27/2015

  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

  3/20/2015

  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?

  3/16/2015

  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.

• Is A Customer-Centric Strategy A Fit For Pharmaceutical Manufacturing?

  1/27/2015

  In an industry such as pharmaceutical manufacturing, which typically focuses on improving operational excellence or coming up with the next big drug, is a business strategy with a customer-first focus the right fit?

• Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency

  12/15/2014

  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.

• FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent

  11/21/2014

  While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.