Outsourced Pharma White Papers
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
2/15/2023
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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Extractables And Leachables: Risk Management And Analytical Solutions
10/11/2023
Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?
12/8/2023
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Revolution In The EU Pharmaceutical Legislation Ahead
2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
6/1/2022
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/21/2024
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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Digital Transformation: A Critical Component For CDMOs
6/21/2023
Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.
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An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market
12/14/2023
Biotech and biopharma developers are increasingly relying on outsourcing partners to meet both clinical and commercial research, development, and production needs. CDMOs that provide end-to-end services, including secure supply chains, can help biologics developers meet accelerated timelines and establish a real competitive advantage in today’s competitive market.