Newsletter | April 25, 2024

04.25.24 -- Impacts Of The Inflation Reduction Act

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Dive into the biopharmaceutical realm, where the synthesis of biologically derived APIs encompasses cell line development, fermentation, and sophisticated purification techniques. Outsourced Pharma Capacity Update’s new PARTNER WEEK will include a session featuring CDMOs with capacity for meeting the production demands of your Large Molecule Drug Substance and Development projects. Join this digital event happening May 21st.

FEATURED EDITORIAL

Impacts Of The Inflation Reduction Act (IRA)

Jesse Mendelsohn, a "pharmaceutical regulatory compliance and government pricing” guru, who manages a life sciences group of over 100 consultants, says currently the biggest disruptor to our industry in 2004 is the Inflation Reduction Act (IRA), the 2023 legislation passed by Congress and signed into law by President Biden. 

How To Measure Cell Density In Real Time With Soft Sensors

Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.

INDUSTRY INSIGHTS

Mycoplasma Contamination In Biopharmaceutical Manufacturing

Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.

The Challenges And Opportunities Of Antibody Therapies

Antibody-based therapeutics are increasing in popularity. Analyze the hurdles of antibody development and manufacturing and explore exciting developments.

Bacteria Media Optimization Using In Silico Strategies

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Gliding Towards De-Risked Combination Product Development

Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

A Technical Package That Serves On-Time Injectable Project Completion

The accuracy and robustness of the technical package an organization submits to its development and/or manufacturing partner are critical to meeting fill project timelines.

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Webinar: Innovative Analytical Strategies to Address Common Development Challenges of New Molecular Formats

Complex next generation biological molecules are becoming increasingly prevalent in today’s biopharmaceutical manufacturing landscape. Through case studies, this webinar will highlight innovative analytical strategies designed to address common challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs and diverse post-translational modifications. Click here to learn more.

SOLUTIONS

Process Development: Mammalian, Bacteria, And Yeast-Based Success

At AGC Biologics, we have developed over 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize process parameters that are critical for achieving a high-quality, cost-effective manufacturing process.

Get Your Biologic To Clinic And Market Faster

We are your one integrated partner with the expertise to get your therapeutic product to market faster, helping you accelerate, simplify, and de-risk your biologics.

Frozen Packaging Solutions

Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.

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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