Newsletter | September 17, 2021

09.17.21 -- An Analysis Of ICH Draft Guidance Q13: Continuous Manufacturing Of Drug Substance And Drug Products

 
Featured Editorial
Industry Insights
Increasing The Efficiency Of Drug Development With Preclinical Testing Using Human Intestinal Stem Cells

Due to a lack of robust in vivo gut models, animal studies are generally required to evaluate gut toxicity. However, these studies can be lengthy and expensive and may not accurately recapitulate the behavior of the human gastrointestinal tract. More efficient development of drugs with attractive side effect profiles requires robust, easy-to-use, cost-effective in vitro gut models that are physiologically representative of the human intestinal tract and thus predictive of in vivo behavior.

Equipment Capability Of Freeze-Dryers And Its Relevance To The Graphical Design Space For Primary Drying

The capabilities of a freeze dryer can change with differences in design. This is particularly important when users are transferring cycles from lab-scale to commercial-scale freeze dryers. Each freeze dryer has its own limitations, and it is important to understand these limitations to avoid the risk of product failure when scaling-up the production. This article summarizes a recent webinar discussing how to measure and compare equipment capabilities of lab-scale and production-scale freeze dryers in order to define optimal design space parameters.

What's The Difference When It Comes To Managing Quality?

QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.

Integrating Design And Industrialization To Optimize Cost, Quality And Time

Explore how integrating the design and industrialization teams can optimize the cost, quality, and time of developing a novel drug delivery system.

The Significant Need For Flexible Aseptic Filling And Isolation Systems In Pharma

Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes, and bottles) with powders and/or liquid solutions. Manufacturing staff, equipment, and premises are all subject to stringent quality controls — and for good reason: patient safety. This document intends to provide information on the latest status, trends, and technologies in parenteral filling equipment.

Real-Time Viable Particle Detection For Definitive Root Cause Investigation
Investigations into viable air excursions are very di¬fficult to perform using traditional methods. The data generated are very limited and not very timely. This often leads to high levels of frustration as the problem persists, with vast amounts of time and resources being consumed while the root cause remains elusive. Read how a real-time viable particle counter is key to providing process improvement in real-time viable particle detection for definitive root cause investigation.
Data Integrity: Understanding And Becoming Compliant With GMP FDA Regulations

Data integrity means data (such as from personnel or environmental monitoring) that are accurate, complete, and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides, and regulations pertaining to data integrity is essential to becoming compliant.

Custom Manufacturing: Translating Research Into Product
Custom manufacturing is not one-size-fits-all and it can be simple or complex, such as producing a single component to a final finished product. Learn what capabilities any potential custom manufacturing partner should have to help you make an informed decision.
The Future Of Shipping In Modern Medicine: Reusable vs. Single-Use Shippers

A shipping solution should maintain the temperature of a product on its journey to the patient, and preserve the intent of the medication, the safety of the investment, and the lives of the patients who depend on them.

A Guide To Cleanroom Construction Methodologies

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

Scale-Up Of Fed-Batch Process In HyPerforma S.U.B.s

Here we demonstrate the scalability of a fed-batch process of Chinese hamster ovary (CHO) cells in Gibco Dynamis Medium with Gibco EfficientFeed C+ Supplement, utilizing a pH shift strategy.

In-Line Dilute-Phase Vacuum Conveying For Conical Screen Mills

Improve the quality of product and realize containment advantages with the use of conical screen mills.

Nutritional Medicine Manufacturer Installs Two-Lane Checkweigher To Keep Up With Demand

Orthomol pharmazeutische Vertriebs GmbH develops and markets an extensive range of food supplements. Annually, over 50 million pouches and 12 million drink bottles leave the premises. A new two-lane C35 AdvancedLine checkweigher excels in high weighing accuracy and throughput, and its versatile product handling features can be flexibly adapted to changing requirements in Orthomol's production lines.

The Good, The Bad, And The Ugly: How Does Identifying And Mitigating Potential For Immunogenicity And Immunotoxicity De-Risk And Accelerate Your Drug Development?

Explore the challenges of assessing the immunosafety profile when moving a drug candidate to first-in-human (FIH) studies, including key considerations and pitfalls to avoid along the way.

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