BlogHeader.png

Case Study: Stability When You Need it Most

The top pharmaceutical developers and manufacturers pride themselves on their ability to successfully manage and mitigate risk. Some implement dual sourcing strategies to secure their supply chain, like Alcami’s Protect Your Brand® program. Others invest in infrastructure to minimize project disruptions, but even the most meticulously-planned backup strategies can fail and emergencies can still disable sophisticated protection measures. What happens when critical analytical testing timelines are threatened?

In this case study, Alcami’s laboratory services experts quickly stepped in to save a new client’s key stability study, and in the process became their trusted solution provider.

Topics: Resource Center Stability

eBook: Guide to Stability

Stability is an integral part of the drug development process. With every stability study, it is essential to focus on the quality attributes of the product— most importantly safety.

Throughout this guidebook, Alcami scientists will discuss stability testing procedures, the  “how” and “what” of degradation in the measurement of shelf life, the importance of storage conditions, and the necessity of following a medication’s recommended guidelines.

 


Topics: Resource Center Stability Analytical Testing

Editorial: Stability Testing Ensures Proper Packaging for Drug Storage

Alcami recently contributed to an article featured in BioPharm International titled "Stability Testing Ensures Proper Packaging for Drug Storage." 

Stability testing is essential for maintaining the integrity and quality of biopharmaceuticals and for assessing an accurate shelf-life. It is an important aspect of quality control and is an important step in evaluating product safety and efficacy. It is also important for examining how critical quality attributes (CQAs) of a drug substance vary with time under different environmental factors.

Topics: Thought Leadership Editorials Stability

Stability: Back to the Basics - Part V

Part V: The Summation of Stability and Quality Attributes

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

The final post in this series examines the summation of stability’s role in the drug formulation process. From molecule discovery through product release to market, quality attributes are carefully analyzed to support product success and protect patients.

In the first step of the drug formulation process, drug discovery or the non-clinical phase, researchers investigate new understandings about a disease and design a product to stop or reverse its effects. Advanced technologies are explored, often to either target drug substances/active pharmaceutical ingredients (APIs) to specific locations within the body or to manipulate genetic material. During this phase, extensive research and development on how the finished product will be formulated also occurs.

Topics: Thought Leadership Stability

Stability: Back to the Basics - Part IV

Part IV: Stability and the Importance of Storage Conditions

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.


After expounding on the importance of efficacy and degradation in the previous blog, this fourth edition of the stability series will answer the most common questions people have about storing medicines and explain how storage plays a direct role on a product’s efficacy, along with which studies are used to measure efficacy.

Is it necessary to read the storage conditions listed on the label? Could where I keep my medicine damage it?

Yes! How medicine is stored influences its efficacy and safety. Remember to always follow the recommended storage conditions for the best use of a finished pharmaceutical product.

Topics: Thought Leadership Stability

Stability: Back to the Basics - Part III

Part III: Measuring Shelf Life— Product Efficacy of API and Finished Drug Products

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

The Federal Drug and Food Administration (FDA) states that “Stability studies should include testing of those attributes of the active substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The justification of individual and total upper limits for degradation products should be based on safety and/or efficacy consideration.”

Safety, quality and product efficacy work together in stability studies of Active Pharmaceutical Ingredients (APIs) and finished drug products. Through stability testing, pharmaceutical companies like Alcami have the ability to identify and trend shelf life and their affects on efficacy as samples are exposed to time, light and temperature.

Topics: Thought Leadership Stability

Stability: Back to the Basics - Part II

Part II: The Impact of Stability on the Safety of API and Drug Products

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

Can you answer any of these questions?
- Exactly how safe are your drugs?
- Do you know the active ingredients in the pills that you are taking?
- What is the purpose of your medication?

Let’s be honest. Most people take these questions for granted. One quality attribute that all companies in the pharmaceutical fields strive for is the safety of drug products.

Topics: Thought Leadership Stability

Stability: Back to the Basics - Part I

Part I: The Importance of Stability in the Evaluation of Quality Attributes of Pharmaceutical Drug Products

In this five-part blog series, Alcami subject matter experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals, beginning with quality attributes.

Exactly how important is stability testing in the life of the active pharmaceutical ingredient (API) or drug product?

The quality attributes that everyone strives for are safety, product efficacy and integrity, appropriate storage conditions, and shelf life.

Topics: Thought Leadership Stability

In-Use Stability Testing: Providing the Right Instructions

In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products section 2.2.10, In-use Stability Testing is defined as:

“The purpose of in-use stability testing is to provide information for the labelling on the preparation, storage conditions and utilization period of multi-dose products after opening, reconstitution or dilution of a solution, e.g. an antibiotic injection supplied as a powder for reconstitution.” 

Like many guidance statements, it appears simple enough to understand, but then reality sets in.  How can a laboratory study be designed to execute potential real world uses of a product for a hospital or clinic?  How many lots of product are needed to meet expectations of the regulatory authorities?  Which batch(es) should be used in the in-use stability testing studies?  What analytical testing should be performed and at what time points should the testing be performed? 

Topics: Thought Leadership Stability

Bringing the Light to Photostability in Three Parts - Part Three

Part 1: Basic Requirements – Setting the Stage

Part 2: Forced Degradation Studies to Support Photostability

Part 3: The Protocol Generation - Execution and Reporting of a Photostability Study

In this third and final section of our photostability series, the protocol design, execution and reporting of the confirmatory photostability for API and pharmaceutical products will be discussed.  ICH guidance Q1B presents a straight-forward flowchart that initiates with the direct exposure of the dosage form.  To initiate a study, a protocol should be written based on the steps outlined in the flowchart.  However, not every step in the flowchart is needed. 

At this point in product development, it is very likely that the photo-sensitivity of the API is known.  If the API is photo-labile, a prudent step would be to write the protocol to direct exposure of product and exposure of the product in its immediate packaging would occur simultaneously.  Not only would this save time, but would demonstrate the effect of the immediate pack has in protecting the product from photo-degradation.  On the other hand, if the API is photo-inert, the direct exposure of the product may be the only exposure required.  As stated in guidance, each exposed foil-wrapped dark control sample should be exposed and tested. 

Topics: Thought Leadership Stability