Newsletter | September 30, 2024

09.30.24 -- When Should You Select Your Supply Partner?

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Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

FEATURED EDITORIAL

When Should You Select Your Supply Partner?

In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise

BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

The Shifting CDMO Landscape – Don't Lose Your Balance

Our panelists describe how the landscape of today’s CDMOs continues to “shift,” what that means, and how to select and form solid partnerships within the changes.

INDUSTRY INSIGHTS

4 Questions To Ask Your Fill Finish Partner

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

Treating Deficiencies In Employee Training And Mentorship

Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

Reducing ADC Timelines With Integrated Development And Manufacturing Services

ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. A CDMO can help bring these treatments to patients safely and efficiently.

ABC: Analytics For Biomanufacturing

A partner who is dedicated to providing state-of-the-art services and working collaboratively with clients can support the production of innovative therapies in the biomanufacturing industry.

How A Drug's Molecule Type Affects Several Bioanalysis Parameters

Discover why bioanalytics are crucial to selecting promising drug candidates during development and to characterizing the pharmacokinetic and pharmacodynamic profile of the drug in early clinical trials.

Adapting An Adherent hCK Cell Line To A Serum-Free Suspension RCB

Learn about the development of a serum-free suspension MDCK cell line that serves as an optimal platform for isolating human influenza viruses from clinical samples and producing vaccines at scale.

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Overcoming The Solubility Challenges Of Antibody-Drug Conjugates

Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

Ensuring Quality And Consistency In Biologics Comparability Studies

Uncover a comprehensive framework for conducting robust comparability studies that ensure biosimilars meet stringent standards for safety, efficacy, and quality.

Improve Scalability And Manufacturability Of A Cytotoxic ADC

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification.

Ensure Data Quality Through Mass Balance Calculations

Improve your cell line performance and process optimization using a cloud bioreactor that enable accurate, real-time monitoring of the whole cell culture fluid mass.

The Critical Role Of Comparative Analytical Assessments

Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

NEW PODCAST EPISODE

An AI Awakening With Profluent Bio's Hilary Eaton, Ph.D.

Hilary Eaton, Ph.D. was a self-described AI skeptic, particularly regarding using the tool in drug discovery. Then, a series of professional and deeply personal life events and medical discoveries put her in a position to confront that skepticism head-on. On Business of Biotech, the Chief Business Officer at ProFluent Bio shares her story and makes a pragmatic case for the transformative value of AI to biotech builders. Listen now!

SOLUTIONS

Choosing A CDMO With Capacity Designed For You

CEO and Founder of INCOG BioPharma Services, Cory Lewis, explains how we are proud to be able to manufacture for the future of medicine.

A Single-Use, Automated Filtration System For Robust Process Control

Learn in-depth about a single-use, automated filtration system designed with a compact form factor for operator convenience and configurable to meet your unique process requirements.

Live Biotherapeutics And Next Gen Manufacturing

With services to develop and scale up Probiotics, Postbiotics, and Microbial Therapeutics, explore how our capabilities can take your drug product to market safely and efficiently.

ATON Bio Capacity Update July 2024: Large Molecule Development

Gain insights into boosting efficiency, fostering innovation, and how integrated capabilities generate value for innovators.

PIC/S GMP Production

Mycenax’s state-of-the-art biomanufacturing site is PIC/S GMP certified. Our highly qualified and well-trained team routinely manufactures high-quality biopharmaceutical products by mammalian cell culture and microbial fermentation processes.

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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