Drug Substance

May 30, 2019
Published by Meranda Parascandola at May 30, 2019

Need to Know about CMC Regulatory Affairs? Consider What Makes a Great Philly Cheesesteak!

what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.
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October 17, 2019
Published by Meranda Parascandola at October 17, 2019

Developing a Phase-Appropriate CMC Matrix

The landscape of chemistry, manufacturing, and controls (CMC) has continued to shift over time. Just a few decades ago, most drugs were developed from beginning to end by large pharma with well-defined systems of control. Today, this has significantly changed; much if not most early development (Pre-IND to Phase II) work is performed by small- to medium-size emerging biotech sponsors, many of which are virtual companies.
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June 23, 2020
Published by Meranda Parascandola at June 23, 2020

The Odd Couple – Part 2: Authoring the Manufacture of Drug Substance and Drug Product Modules (S2, P3)

An overview of the quality assurance aspects of the manufacturers may provide insight into the viability of the process. Although not required to be included in the application, a request for the report of the most recent cGMP manufacturing inspection from the US Food and Drug Administration (FDA) and/or European Union (EU) agencies enable a broad overview of the cGMP compliance aspects of the facilities.
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July 14, 2020
Published by Meranda Parascandola at July 14, 2020

The Odd Couple – Part 4: Authoring the Analytical Control and Analysis and Reference Standards Modules

Perhaps the most consequential specification input is analytical method capability. The attribute of interest must, after all, be assessable. Thus specifications depend on the method’s specificity, sensitivity, variability, and accuracy.
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July 23, 2020
Published by Meranda Parascandola at July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.
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August 13, 2020
Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.
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August 19, 2021
Published by Meranda Parascandola at August 19, 2021

Trust and Expertise: Defining The Value Of The Person-In-Plant

As sponsors have started to shift more and more of their manufacturing to outsourcing partners, relationship building has become an even greater priority. This is where the person-in-plant becomes an invaluable source for building a more trusting relationship with the contract research manufacturer (CMO). Essentially, a person-in-plant is a sponsor employee or, more often, a third-party expert consultant who is present at the contract manufacturing site to observe, support, and provide feedback to all stakeholders.
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