Biopharmaceuticals have transformed the patient care landscape, but alongside this step change in treatment capability comes the need for a similar paradigm shift in manufacturing capability. Here, Maik W Jornitz, President & CEO of G-CON Manufacturing Inc. highlights how cleanroom infrastructure must develop to keep pace with ever evolving industry needs.
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Issue 2 2021
In the arsenal of approved small molecule drugs, effective, genetically-targeted therapies for the treatment of autoimmune diseases are conspicuously scarce. ImmunoMolecular Therapeutics (IM Therapeutics) has developed a paradigm for the discovery and development of new molecular entities as a broad platform for blocking genetic targets that confer risk of disease development…
The dedication of the science community and healthcare workers in the fight against COVID-19 has been unwavering and justly praised. Yet logistics workers and the industries that support it have also achieved tremendous feats to support the resulting aid. Here, Zoe McLernon, Multimodal Policy Manager at Logistics UK, highlights the…
Information is king – and real-time data regarding material stock movements is essential for effective inventory management. Here, Mostafa Eissa from Cairo University demonstrates the use of statistical processing control techniques for monitoring material mobility and how this could benefit the pharma industry.
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
Nanoparticles for drug delivery: next-generation biological drugs to treat inflammatory bowel diseases
Nanoparticles offer a promising alternative to conventional drug delivery that allow for more precise targeting and controlled release. Here, Dr Fabrice Navarro discusses the benefits of these nanocarriers and their potential as a therapy for inflammatory bowel diseases (IBDs).
Product hub: How can you ensure product quality if you are not in control of your manufacturing environment?
Without confidence in your environmental monitoring (EM) data and microbiological testing, you can never be completely sure that your products are free from unwanted microorganisms. Our Accugenix® microbial identification and strain typing services offer unparalleled accuracy that you can rely on.
Nelson Labs is the leading global extractables and leachables lab testing platform, in this guide find out about their other services and how, from development to delivery, they can help get your products to market.
In this in-depth focus, discover why testing for heavy metal contaminants in cannabis vaping aerosols is a pressing need, how using trending charts to monitor inventory movements could benefit pharma, the regulatory requirements for analytical balances operating in GMP and GLP laboratories and the different HPLC methods available for oligonucleotide analysis.
Oligonucleotides are diverse in nature, with a wide range of applications. Here, Dr Anastassia Kanavarioti and Dr Sandra Rontree explore the challenges of oligonucleotide analysis in the life sciences sector and outline the different HPLC methods available for the job.
In light of the increased popularity of cannabis vaping in the United States, new regulations in the state of Colorado assert the need to test for heavy metal contaminants. Here, Robert Thomas explains the reasons for this pressing need and the challenges it presents.
In this article, Charles River Associates (CRA) delves into why traditional vaccine procurement schemes are not fit for purpose during the pandemic and how both governments and manufacturers must adapt to manage the greater level of risk associated with pandemic vaccine development and distribution.
The ability to precisely direct powerful therapeutics not only makes treatments more effective, but also prevents debilitating side effects. Here, Dave Elder and Stacey Treichler highlight the great potential of antibody-drug conjugates (ADCs) for improved treatment of oncology indications and beyond.
Plasma-derived therapies and medicines provide life-changing treatments for patients around the world who suffer from serious, and often rare, diseases that affect the immune system or result from non-functioning proteins in blood plasma. Carole Resman, Executive Vice President Production at LFB, describes the complex and highly regulated manufacturing process of…