Newsletter | July 30, 2024

07.30.24 -- Navigating ADC Manufacturing Complexity

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Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific.

FOCUS ON OUTSOURCING

Navigating ADC Manufacturing Complexity

Antibody-Drug Conjugates (ADCs) are a hot and promising commodity, and a ballooning clinical-stage ADC development community is putting stress on both manufacturing capacity, and antibody engineering and conjugation talent. What does this burgeon mean for ADC manufacturing, process development, and, ultimately, clinical progress?

8 Key Partner Quality Attributes Your CDMO Must Have

Identifying the best CDMO partner is an integral component of many biopharma businesses. CDMOs can help mitigate the complexity and costs of drug substance development and drug product manufacturing.

Calculating Your Business Case For Continuous Manufacturing

Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.

Creating A Successful Business And Technical Relationship With A CDMO

Examine strategies to ensure both you and your CDMO are prepared to address the challenges of bringing a new biologic drug to market and discover the path towards a successful CDMO partnership

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

Plasmid DNA And Advanced Therapies: Accelerating Path To Clinic

Examine the challenges CGT innovators face and how adhering to GMP requirements from an early stage helps ensure successful downstream applications from early clinical development to commercial phase.

Biotechnology: The Key To America's Next Manufacturing Revolution

Learn how a recent expansion into Western Pennsylvania is aiming to enable more biopharmaceutical firms to translate cutting-edge science and research into practical applications.

Plan Your CDMO Search On A Foundation For Long-Term Success

Capacity constraints typically are accompanied by other challenges, including missed timelines, defect rates, and overall decreased satisfaction with pharma companies’ bioprocessing CDMOs.

Next Gen Plasmid Technology: Improve Performance, Safety, Manufacturing

Nanoplasmids have paved the way for facilitating a wide range of cell and gene therapeutic applications. Gain an overview of a novel technology and specific benefits.

OUTSOURCING SOLUTIONS

Small Scale Feasibility - Viralgen

XS Technologies Microbial Platform For Protein Expression - Lonza

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services - FUJIFILM Diosynth Biotechnologies

Partnering With You From Preclinical Through Commercial Scale - Andelyn Biosciences

Bionanoparticle Technology - Nanoform

Antibody-Drug Conjugates - Mycenax

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