Newsletter | January 23, 2025

01.23.25 -- Keep An Eye On These Analytical And Monitoring Trends In 2025

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We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success. Learn more and register to save your seat!

FEATURED EDITORIAL

Keep An Eye On These Analytical And Monitoring Trends In 2025

Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.

2025: Navigating Partnerships Amid Political And Economic Shifts

Collective message members of the Outsourced Pharma Editorial Advisory Board shared that we should brace for a potentially turbulent 2025, revealing a landscape where geopolitical tensions, regulatory evolutions, and emerging technologies will affect how you develop and manufacture drugs.

INDUSTRY INSIGHTS

Bispecific Antibodies: Navigating From Design To Market Success

The design of bispecific antibodies requires an assessment that takes the following aspects into account: half-life, mechanism of action, and manufacturing challenges like impurities and low yield.

ICH Q14 101: Applying AQbD To CMC For Regulatory Success

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

Optimizing Virus Filtration Validation

Explore guidance regarding the effective validation of a virus filtration process in the laboratory, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.

SMARTag Technology, From Bertozzi Lab To Best-In-Class ADCs

Hear experts discuss the latest trends in antibody-drug conjugate (ADC) discovery and development and how next-generation pipelines are being shaped by payload and linker-chemistry innovations.

Identifying New, Enhanced Device Delivery Solutions For Chronic Diseases

Shorter needles with ultra-thin wall technology for prefilled syringes enable the delivery of larger, more viscous drug volumes, significantly improving the end-user experience.

Reduce The Environmental Footprint Of Oligonucleotides

Industry experts answer attendees' questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

Engineering E. Coli For Novel Biopharmaceutical Manufacturing

Recent advancements in genetic engineering and analytical techniques have significantly enhanced E. coli's potential for protein expression.

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

Cell Line Development For Multi-Chain Biologics

Review the use of a platform that creates CHO cell lines for manufacturing multi-chain biologics, highlighting the uniformity of titer across generated pools and the rapid pool selection process.

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Webinar: Essential Considerations for Selecting the Right Biologic Fill/Finish Partner

Choosing the right Fill/Finish partner ensures drug safety and operational efficiency. A reliable partner minimizes risk, prevents contamination, and improves yield, ultimately saving costs. This webinar highlights four key questions to identify a quality-focused provider. Key takeaways include reducing risks while increasing yield, assessing partner quality, and understanding the value of an experienced partner in meeting therapeutic goals. Click here to learn more.

SOLUTIONS

Capacity Update October 2024: Large Molecule Drug Substance

Gain valuable insights into our mammalian development services, manufacturing solutions, upcoming capacity availability, as well as updates on expansion timelines for external clients.

Analytical And Quality Control

Learn how robust in-house analytical services and protein characterization are crucial for successful development and manufacturing programs.

Injectable Drug Manufacturing

From the production floor to the shipping door, your unique clinical or commercial requirements will be fulfilled at each step of the process.

Live Biotherapeutics And Next Gen Manufacturing

With services to develop and scale up Probiotics, Postbiotics and Microbial Therapeutics, see how Sacco System’s capabilities can help take your drug product to market safely and efficiently.

Integrated Biotech Services: From Strain To Commercial Product

Backed by Lonza’s more than 30 years of expe­rience and expertise in biological processing and our track record in the chemical and bio­technological industry, we offer our customers a full “one-stop-shop."

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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