Contract Pharma Manufacturing White Papers & Articles
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In-House Manufacturing: Key To Driving A Diabetes Vaccine?
1/28/2022
Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.
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Formulation Development Strategy For Early Phase Human Studies
1/27/2022
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
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Rational Design Of Oral Nanosuspensions For Insoluble Drugs
1/26/2022
The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.
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Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
1/26/2022
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
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Formulation Development From Preclinical To First-In-Human
1/24/2022
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
1/24/2022
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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Lessons In Scaling Lipids Production And Purification
12/13/2021
The speed at which the pharmaceutical industry is now developing and manufacturing mRNA drug products at large scale is astounding, yet it has highlighted supply chain vulnerabilities to make the required pharmaceutical ingredients such as lipids.
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Key Considerations When Choosing A CDMO
12/6/2021
When choosing a CDMO, pharmaceutical companies can help ensure their project’s success by focusing on five primary attributes to look for in a potential partner.
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Achieving Biologics Manufacturing Milestones Using A Systemic Approach To Technology Transfer
12/2/2021
Discover a systemic approach for executing a technology transfer to achieve "100% first time right," which involves assessing confidence levels for processes and analytical methods using a decision tree and arriving at risk mitigation strategies.
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The M.O. Behind Choosing A CDMO: Three Considerations For New Drug Developers
11/29/2021
The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside. Discover three considerations that build a foundation for partnership.