Newsletter | June 25, 2024

06.25.24 -- Managing Change In Vaccine Production With All Stakeholders


Tech Transfer strategies and best practices to optimize your clinical and commercial supply

Tech Transfers for biological products are complex, challenging processes. Join us on July 11th for an insightful webinar on the critical aspects of technology transfer of either drug substance or drug product. This session will delve into the strategies and best practices for seamless tech transfer processes, ensuring regulatory compliance, and maintaining product quality and consistency. Click here to learn more.


Managing Change In Vaccine Production With All Stakeholders

Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.

Set Your Oversight Early, But Do Not Dictate All The Rules

As more and more sponsors partner with CDMOs to leverage their expertise and capabilities, utilizing the right framework to manage a partner is crucial for the relationship to function optimally.

Leveraging CDMO Expertise To Achieve Aseptic Fill/Finish Success

Achieving high-quality drug product requires a combination of meticulous quality control measures, personnel expertise, and judicious application of technology — benefiting patients and the industry.

Project Management: The Secret Weapon In Effective Tech Transfer

Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.

Advancing Viral Vector Gene Therapies With Strategic Partnerships

The right manufacturing partnership could help a viral vector gene therapy sponsor's program to flourish. A CDMO’s project management, facilities, and expert staff can help accelerate patient access.

How CDMOs Can Support Today's Mammalian Clinical Manufacturing

Finding a CDMO partner capable of guiding emerging biotechs throughout their product’s life cycle and accelerating time to market is crucial for maximizing the success of your novel therapeutic.

Successfully Producing Insoluble Proteins Using Inclusion Bodies

Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

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 clinical development to commercial phase.

The Value Of Engaging A Single CDMO For Comprehensive Biologics Services

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.


ADCs: From Design To Development - Abzena

Live Biotherapeutics And Next Gen Manufacturing - Sacco System

Speed Up Your Plasmid To Clinic - OBiO Tech

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

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

Meeting The Unique Needs Of Your Sterile Injectable With Exact SI-ence - Pfizer CentreOne

mRNA/LNP Development And Manufacturing Services - Lonza

Cell Line Development - Mycenax

The Comprehensive Cell Therapy CDMO, From R&D To cGMP Manufacturing - Theragent


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? Join Bioprocess Online Live on July 9th as we navigate the complexity of the ADC manufacturing environment. From linkers to payloads to conjugation, we’ll cover the lay of the land for developers. Registration is free thanks to the support of Cytiva.

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