Volume 2.8 September 2024

Dear Colleague,

We are starting a new occasional blog series looking at the various organizations that advocate for chemists, CDMOs, pharma, and related sectors. The first is about a pair of organizations that SK pharmteco belongs to that are working to address regulatory harmonization and drug shortages.

We have a new webinar, Advancing Viral Vector Manufacturing with Innovation: the Importance of the Cell Line, an upcoming webinar, Control Strategies and Method Development for Nitrosamines in APIs & Drug Products, along with plenty of new items in the Media Center. Another webinar, The Evolution of an Adherent HEK293 Cell Line, is still available, too!?

Part One: EFCG Membership Assures Supplies of Affordable Medicines to Patients

The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examine the European Fine Chemicals Group (EFCG) and its parent organization, the European Chemical Industry Council (Cefic). SK pharmteco is proud to be a member of both organizations...

Read More

and on a related note:

EU Tackles Drug Supply-Chain Vulnerabilities: Is Onshoring in Play??

Evaluating drug supply chains in the EU

The European Commission has released results from a pilot study evaluating the supply-chain vulnerabilities of 11 critical medicines, including manufacturing dependencies of APIs from outside the EU. What did the study show, and what is next?...

Read More

Advancing Viral Vector Manufacturing with Innovation: The Importance of the Cell Line

Learning points from the webinar:

• Gain insights into innovative cell line development for AAV, LV, and adenovirus production;
• Understand the development of a high-performing, monoclonal, suspension HEK293 cell line for CGMP cell banking;
• Assess the comparison with industry-standard cell lines;
• Visualize the at-scale cGMP cost savings realized with an optimized manufacturing cell line;
• Learn about the next steps and future advancements in viral packaging cell line evaluation to keep improving our processes and platforms for your cell and gene therapies.

Register & Watch Now

Learning points from the webinar:

• Discussion of the regulatory landscape for nitrosamines and nitrosamine drug substance-related impurities (NDSRIs)
• Learn how to select the right analytical technologies for nitrosamines assessment
• Understanding different method development and validation strategies

Who Should Attend:

• Chemistry manufacturing control (CMC) and regulatory leaders
• Analytical scientists working in method development
• Scientists with an interest in the determination of drug substance and product nitrosamines control
• Scientists with an interest in high-performance liquid chromatography (HPLC) or GC separations and MS
• Procurement and sourcing managers in the pharmaceutical industry

Register Now

News, Webinars, Blogs, & White Papers of Interest

Here are a few items that might be of interest.

• Press Release: SK pharmteco’s Swords Facility Celebrates 60 Years of Pharmaceutical Excellence!

• Article: BioPharm International: Advances in Filtration Technology
• Press Release: SK pharmteco Appoints Patrick Mahieux as President of Cell and Gene, Europe?
• Interview: Scrip: SK pharmteco Focusing On BAU Amid BIO 'Buzz', BIOSECURE
• Interview: Slice of Healthcare: Joerg Ahlgrimm, CEO at SK Pharmteco, Discusses CDMO Leadership
• Article: Contract Pharma: Contract Labs Grow Versatile as Demands Go Diverse

SK pharmteco Conferences

The season for the meeting is in full swing, and SK pharmteco has many upcoming conferences and would love to meet with you at any of them. Click through the links for more details.

• Meeting on the Mesa October 7-9, 2024, Arizona Biltmore, Phoenix, AZ. SK pharmteco will be exhibiting and have a morning workshop session.
• CPHI Worldwide Milan October 7-9, 2024, Fiera Milano, Italy. SK pharmteco will be exhibiting at booth 5D33 with a full contingent of team members. You can shedule a meeting here.
• SPICA Milan 19th International Symposium on Preparative and Industrial Chromatography and Allied Techniques October 15-18, 2024,?Politecnico di Milano - Bovisa Campus Aula Carlo De Carli Via Durando - Building B9 Milan Italy. SK pharmteco will be attending.
• AAPS October 20-23, 2024, Salt Palace Convention Center, Salt Lake City, Utah.
• The 19th Annual Peptide Therapeutics Symposium, October 22-23, 2024, Scripps Seaside Forum, San Diego, CA. Marc Jacob will be presenting.
• ESGCT October 22-25, 2024, La Nuvola, Rome, Italy. We will be exhibiting.

Evolution of an Adherent HEK293 Cell Line into a CGMP Serum-free Suspension Cell Line for Universal AAV, LVV, and AV Vector Production

Key topics covered in the white paper include:

• The importance of finding optimal cell lines for the Generation of CGMP Master Cell Banks;
• Technical challenges and solutions in developing a high-performing monoclonal suspension HEK293 cell line for CGMP cell banking;
• Applications and impact on viral vector production for cell & gene therapy and research.

Download

Thank you for your previous interest in services and content from SK pharmteco. Should you have any questions, please?contact us and thank you for reading!

For the very latest updates from SK pharmteco, follow us on social media.