QA/QC In-Depth Focus
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
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Articles
Environmental Monitoring In-Depth Focus 2017
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
Guide to Ingredients
In this guide to ingredients, two leading companies involved in testing and analysis explain how their service offering meets current industry needs...
Extractables – leachables correlations for packaging
Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.
Biopharmaceutical Development & Processing In-Depth Focus 2017
In this in-depth focus: Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. Is high resolution mass spectrometry the missing piece in continuous bioproduction? Regulatory, clinical and logistics challenges of ATMPs in clinical research...
Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs
A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…
Continuous manufacturing: regulatory and quality assurance challenges
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
Developing OTC syrup packaging for the highly regulated EU market
The regulatory environment has a great impact on business, especially in healthcare. Non-compliance exposes companies to the risk of launch delay, delisting products from the market and out-of-stocks. Moreover, it can cause reputational damage affecting staff, consumer and shareholder confidence, reduce market opportunities, and affect the bottom line.
Current trends in freeze-drying
This article reviews the trends in freeze drying highlighted at recent Parenteral Drug Association (PDA) conferences...
Outsourcing FM to drive excellence in premises and equipment management
When reviewing the range of activities required to deliver pharmaceutical products of the required high quality within a strict regulatory framework, an organisation will identify services, which while still business critical, are considered as non-core to the mission of the organisation. These non-core services still need to be delivered, either…
The importance of being small: miniaturisation of freeze drying equipment
Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…
Extractables and leachables – safety-based limits
A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
Issue #4 2017 – Digital Version
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
World-class CDMO: process development and GMP production baculovirus expertise
Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Sharyn Farnsworth, Associate Principal…
Risky endeavours for biosimilars market
Bringing a biosimilar from early development to market is a risky endeavour say Magnus Franzen (left) and Chris Isler, biosimilar experts at PA Consulting Group...
