Newsletter | November 19, 2024

11.19.24 -- A Comprehensive Guide For Supplier Quality Agreements

SPONSOR

Webinar: Charting a Successful CMC Journey for your ADC Drug Product

Join us to understand best practices and explore real-world case studies in bioconjugates and ADC drug product development and manufacturing. You’ll learn about new Drug Product High Potent capabilities from pre-clinical development to commercial supply and find out about flexible entry points with unique tailored approaches for every ADC phase. Click here for more information and to register.

FOCUS ON OUTSOURCING

A Comprehensive Guide For Supplier Quality Agreements

This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.

Improving Safety And Efficacy With Charged Variant Characterization

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

4 Questions To Ask Your Fill Finish Partner

Reducing risk while maximizing API volume is critical during the fill finish phase of biopharmaceutical manufacturing. To ensure safety and quality, partner with an experienced fill finish provider.

Navigating Bioconjugate Development

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, discuss complexity and uncertainty in the bioconjugates market.

Liposomal And Nanoparticle Technology

Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

Ensure a smooth and efficient technology transfer by following key strategies and avoiding common pitfalls to streamline your process and achieve consistent, error-free results.

Commercial Vs. Technical Priorities: The PM High-Wire Act

PMs must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

Enabling Novel CRISPR-Cas9 Delivery: Supporting Innovative Genomics

An institute researching CRISPR-based genome editing required a custom, highly pure, ultra-low endotoxin nuclease. Learn how Aldevron's expertise helped to demonstrate reduced immune responses compared to using AAV serotype 9 for delivery.

Addressing Complex Challenges And Developing Innovative Solutions

Explore two projects that a focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

Why Partner With A CDMO Dedicated To Transparency, Robust Analytics

Poland’s biomanufacturing scene presents an array of benefits to drug sponsors looking to partner globally, including cost-effectiveness, economic stability, and a culture with a strong work ethic.

Addressing Patient Access To Medicines With Interconnected Networks

Providing access to a well-established manufacturing network removes the risk of multiple tech transfers and third parties needed to achieve scale.

4 Critical CMO/CDMO Capabilities

This comprehensive guide equips contract manufacturers with the tools to thrive in the ever-evolving life sciences industry. Read how to streamline and optimize your contract manufacturing operations.

Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.

Tackling Cell And Gene Therapy Manufacturing Challenges

Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path from discovery to commercialization.

How Fast-Track Strategies Accelerate Time-To-Clinic

Biopharmaceutical sponsors can minimize to-clinic timelines by using innovative development strategies that trade potentially increased risk for time savings.

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

SPONSOR

Webinar: From Apollo™X cell line to 20K L Bioreactor: Partnering manufacturing strategies and facility design for patient-centric medicine delivery

Join us on November 21st for a presentation that highlights the importance of selecting effective manufacturing strategies and the impact of global supply chain challenges on biologics. Key learning objectives include evaluating production strategies and understanding how modular designs enhance scalability and reduce risks. Click here to learn more.

OUTSOURCING SOLUTIONS

Particle Control In Biopharmaceuticals - Lonza

Bioreactors And DOE Expertise To Characterize Your Process - Culture Biosciences

Our Biotech Success - Levicept - Lonza

Large Molecule Expertise. Ingenuity You Can Count On. - Cytovance Biologics

cGMP Manufacturing - Microbial System - EirGenix Inc.

Simtra Capabilities Overview - Simtra BioPharma Solutions

Your Expert Partner In Bringing Biologics To Market - AbbVie

Capacity Update October 2024: Large Molecule Drug Substance - Northway Biotech

Formulation Development: Navigate The Complex Concept-To-Market Path - Abzena

Seamless, End-To-End Cell & Gene Therapy CDMO - GC Cell

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