Pharmaceutical Technology recently spoke with our SVP of Science & Technology, Parviz A. Shamlou, about the potential impact that the Biosecure Act may have on the pharmaceutical industry, as well as the progress of continuous manufacturing in #biopharma. Parviz shares, “We appreciate that [the Biosecure Act] is an important act designed to protect the health of citizens of this country. And we know we must do everything we can to avoid any unintended, potentially harmful use of our services as highlighted in the act,” says Shamlou. “Abzena has put in place a robust contingency plan as well as a CMC strategy designed to mitigate any such risk to the supply chain and the development of the assets that our customers bring to us.” Click here to listen to the interview: https://lnkd.in/eAMc4fiP #CDMO #CRO #Drugdevelopment #Supplychain
Abzena’s Post
More Relevant Posts
-
Achieving your Target Product Profile (TPP) for your complex #biologic or #bioconjugate requires a robust and comprehensive approach to formulation development. Having delivered over 1400+ programs, our expert scientists prioritize solubility, delivery, safety, and sustained stability to ensure that your biopharmaceutical successfully transforms from a concept into a market-ready therapeutic. Our flexible and customizable approach coupled with advanced technologies such as mass spectrometry, particle size assessment, and UPLC/HPLC systems, helps to ensure a streamlined and de-risked path to the clinic and beyond. From initial pre-formulation studies and generation of a formulation to support toxicology and first-in-human trials through to clinical in-use studies, formulation optimization, and device interaction studies - our comprehensive suite of services enables us to support your program throughout its entire lifecycle all under a single organization. Access our latest info sheet to discover how our formulation development expertise can rapidly progress your project to its next target inflection point: https://lnkd.in/ef7JX5Hv #FormulationDevelopment #CDMO #CRO #DrugDevelopment
To view or add a comment, sign in
-
-
Scaling-up a #biologic from clinical development to commercial production can present it's own set of unique challenges and possible time constraints. At Abzena, our comprehensive and fully integrated capabilities de-risks and streamlines the path to commercialization, enabling us tackle these challenges head-on. Our cutting-edge facilities and expert teams support every stage - from process development and analytical method development through clinical manufacturing, tech transfer and onward to optimization and commercial manufacture. By offering high-quality, scalable manufacturing capabilities for monoclonal antibodies (mAbs), bispecifics (BsAbs), and other complex biologics, we ensure a robust and consistent manufacturing process that reduces risk, and speeds up time-to-market for your innovative therapies. Discover how Abzena can enhance and accelerate your manufacturing program today: https://lnkd.in/eHxGADyN #Biologics #Manufacturing #DrugDevelopment #CDMO
To view or add a comment, sign in
-
-
It's "Flashback Friday" featuring our San Diego facility tour event during #BIO last month. Guests were transported from the convention center to our state-of-the-art, clinical through commercial scale #biologics development and manufacturing facility in Sorrento Valley. Met with tasty beverages and appetizers, guests mingled with our #scientific and commercial leaders before heading on a tour of our process development and #analytical laboratories and #cGMP manufacturing suites. Thanks again to all who attended! If you're looking to scale-up your antibody program, come and take a tour and meet with our experts in San Diego today! For more information about our San Diego facilities, visit: https://lnkd.in/e9imbFnv #CDMO #CRO #DrugDevelopment #DrugSubstance
To view or add a comment, sign in
-
Independence Day is a time to honor the spirit of innovation and resilience that defines both our nation and industry. At #Abzena we are proud to contribute to the advancement of life-saving therapeutics and thankful for the freedom to push the boundaries of science and technology to improve global health. Thank you to our dedicated team, partners, and customers for their tireless work in bringing transformative therapies to patients worldwide. Let’s continue striving for a brighter, healthier future. #4thOfJuly #Innovation #LifeSciences #IndependenceDay #Biotech
To view or add a comment, sign in
-
-
At WADC in London our team presented a poster showcasing our unique ThioBridge™ conjugation technology that's been proven to improve the stability, potency and efficacy of antibody-drug conjugates (#ADCs). ThioBridge™ addresses key challenges in ADC design and development by leveraging naturally occurring interchain disulfide bonds. This results in a more uniform drug-to-antibody ratio (DAR) profile, improved linker stability and precise site-specificity, ensuring no deconjugation or cross-conjugation issues. Biopharma developers: How might this technology impact your ADC pipeline? Let's discuss the potential for improved efficacy and safety profiles today! Access the poster here to learn more: https://lnkd.in/eU8p5ima
To view or add a comment, sign in
-
-
The development and application of technologies to engineer #antibodies and #proteins has rapidly grown over the last few decades, making engineering a critical aspect in the discovery, design and development of new therapeutic candidates. At Abzena, we eliminate the guesswork from protein engineering by offering robust solutions and proprietary approaches that can be tailored to your specific needs. Our expert team combines cutting edge in silico tools with decades of practical experience to design molecules that demonstrate optimal functionality and manufacturability. Our unique and comprehensive design and engineering solutions include humanization, deimmunization, bispecifics, isotope switching, Fc Engineering, affinity maturation, developability and bioconjugation. Access our latest info sheet to discover how our expert team, technologies and platforms can elevate your #biologic today! https://lnkd.in/eRZajbNE #ProteinEngineering #CDMO #CRO #DrugDevelopment
To view or add a comment, sign in
-
-
In BioPharm International's latest issue, our VP of Cell Line Development (CLD), Simon Keen, shares innovative approaches that can optimize cell line development for next-generation biologics. From vector construction to rapid cloning strategies, he provides insights on how to build a flexible and efficient CLD platform that reduces the potential for bottlenecks in the development pathway. "Efficient and flexible cell line development (CLD) platforms are critical to meeting the growing global demand for biologics." says Simon Keen. Dive into the full article to explore these advancements in detail: https://lnkd.in/epHXRy3d #CDMO #CRO #Celllinedevelopment #DrugDevelopment
To view or add a comment, sign in
-
-
If you’re developing an antibody-drug conjugate (ADC) to treat cancer, you need data-backed answers to these questions: -Is the antibody being internalized? -Where’s the therapeutic trafficked? -Is the drug actually killing cancer cells? And that’s where imaging and bioassays come in. Through a suite of imaging assays, our team of scientists can help you select your lead candidates from hundreds to a handful, making sure that the best candidate progresses to IND filing. We can provide real-time data on internalization, trafficking, tumor-cell killing, and a host of other cell functions. All of these powerful imaging assays and analyses come early on in the development process because we believe in starting smart, so you can progress fast to IND and beyond. Find out more about our assay capabilities here: https://lnkd.in/ez2YMCCD #microscopy #drugdevelopment #CDMO #CRO #ADCCDMO
To view or add a comment, sign in
-
-
Fixed cell immunocytochemistry is a respected industry tool that provides drug developers with early-phase data that helps with lead candidate selection. However, our technical experts think that live cell #imaging is even better. Live cell imaging will show you processes, like calcium signaling or an antibody-drug conjugate (#ADC) targeting cancer cells, in action. If you need to see cells internalizing an antibody in real-time, or a high-throughput assessment of cancer cell-killing by bispecifics, it can do that. Even quantification of ADCs destroying cells in a tumor spheroid, and Ca2+ signaling, trafficking, antibody-dependent cellular phagocytosis (ADCP) or cytotoxicity (ADCC), can all be done using Live Cell imaging. See how our imaging capabilities can support your project today!- https://lnkd.in/ez2YMCCD #microscopy #drugdevelopment #bioassays #CDMO #CRO #ADCCDMO
To view or add a comment, sign in
-
-
Solid data is at the core of every decision made in the drug development process. However, sometimes you need more visibility into your biologic's behavior than flow readouts can provide and that's where imaging can play an impactful role - because after all, seeing is believing. The 3D cancer spheroid featured in the graphic is literally a ball of cancer cells. We use this spheroid to model how well cytotoxic payloads and antibody-drug conjugates (ADCs) can destroy a solid tumor. The red dye is an apoptosis marker, and the green dye signals necrosis, making it easy to visualize just how effective the drug candidate is. Utilizing the expertise of our imaging team, we can bring data to life, turning qualitative cell behavior into quantitative data by providing real-time information about an ADC’s mode-of-action in 2D, 3D and/or co-culture systems. This allows for a more confident lead selection, reducing the risk of future problems, and streamlining your ADC's development process. Ready to see how our microscopy capabilities can help streamline the development of your ADC? https://lnkd.in/ez2YMCCD #microscopy #drugdevelopment #CDMO #CRO #ADCCDMO
To view or add a comment, sign in
-
Biopharmaceutical Process engineer | Bioprocessing | Aseptic Manufacturing | Upstream and Downstream Processing | Process Development scientist
4dCongratulations Dr. Shamlou