Newsletter | April 8, 2024

04.08.24 -- Shocking! Biotech Facilities Don't Maintain Themselves

FEATURED EDITORIAL

Shocking! Biotech Facilities Don't Maintain Themselves

Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

INDUSTRY INSIGHTS

Inclusion Bodies: Mother Nature's Help Or Hindrance?

The pros and cons of soluble and insoluble processes: isolating, solubilizing and properly refolding, and strategies to improve the performance of IB processes.

The Challenges Of Biopharmaceutical Quality

The quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

Q&A: Prioritizing R&D Initiatives To Support Cell Line Development

As drug discovery accelerates, so too does the need for robust cell line development. Learn how a CDMO that prioritizes R&D can help you unlock the potential for faster, more efficient development.

The Promise Of PCM: Getting To Maturity

PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.

Four Steps To Identifying The CDMO Proposal Worth Signing

The leap from sending your RFPs to choosing a CDMO partner requires the ability to think critically about the red flags and green flags of a given proposal.

SOLUTIONS

The Ultimate Guide To Clinical Supplies For Japan Studies

Catalent's local team in Japan provides comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, and local and global distribution.

Capacity Update February 2024: Large Molecule

Simtra currently has open capacity for liquid vial projects at both manufacturing sites and can support rapid tech transfer depending on the complexity of the project and the availability of materials.

Capture Resins For Antibody Purification

Development beyond traditional mAbs is increasing, and today, we see antibody variants like multi-specific and bispecific antibodies and antibody fragments.

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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