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CMC Articles and Insights

PDUFA VII: Implications for Developers of Cell and Gene Therapies

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII, as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA

Advancing from Research to Development: What Can Go Wrong?

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, there are multiple factors regarding development strategy and approach that

GxP Quality Guidelines and Regulations: Frequently Asked Questions

GxP refers collectively to several types of “good practice” quality guidelines and regulations, each serving a specific purpose. In pharmaceutical product development, these include, but are not limited to: GCP (good clinical practice) GLP (good laboratory practice) GMP (good manufacturing practice) GxP standards broadly cover

Technology Transfer: What Is It, and How Is It Done?

Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a manufacturing process to a larger,

Multidisciplinary Team Advances Immuno-Oncology Development

Developing a product from concept to commercialization is a multi-faceted and risky process. Particularly for complex programs, development plans must be customized based on real-world patient experience and optimized for a product’s post-approval success. A cross-disciplinary team is essential for crafting and assessing complex development

Quality Metrics – Coming Soon to Your Manufacturing Facility

The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for approval in 1962 based on the Kefauver-Harris Amendment. Despite this requirement, many drugs that have been approved by FDA have limited efficacy (eg, drugs that treat cancer or Alzheimer’s disease).

New Generic Stability Requirements

After much delay, FDA just released the new guidance on the stability requirements to file and obtain approval of a generic drug product and API under 505j. The new requirements bring ANDAs closer in line with NDAs and ICH. The new requirements as summarized in

Drug Development Planned Like the Titanic

How many drug development companies leave it up to the CMO to design or execute their formulation and manufacturing without oversight? Like those who boarded the Titantic 100 years ago, they seem to trust the mantra that their contractor’s work is unsinkable. MAP Pharmaceuticals seemed

Target Product Profile

In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation of a Target Product Profile early in a development program facilitates reaching the goal of a marketed drug product. It provides a

Can and Should ANDA Labeling Differ from the RLD?

In the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their

Multiple Dosage Strength Products – CMC Considerations

Developing a product with multiple strengths? How do you go about filing multiple strengths in an IND? How and when do you draft one CMC section covering multiple drug strengths for the same dosage form? Long-term drug development goals may include multiple strengths of a

Botanicals: What is the starting material for the API?

We typically work with small molecules of synthetic origin, but occasionally are retained to work with products that have active ingredients from botanical (plant) sources.  Lynn Gold, our VP of CMC provides the following discussion on how to define the starting material for the Active Pharmaceutical Ingredient (API).

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

Today’s posting stems from a client question.  The client’s product candidate is an oral product that requires both single- and multiple dose pharmacokinetic studies. Question:  Do companies ever use one pivotal batch for single-dose (SD) study and another batch for the multi-dose (MD) study?  What