SEARCH

Current Edition

Harnessing the immune system for immuno-therapeutics
Volume 1 Issue 3

Harnessing the Immune System for Immuno-therapeutics and the Crucial Need for Translational Approaches to Safety Assessment Studies

Every day our bodies are exposed to millions of pathogens, through contact, ingestion and the air we breathe in. The innate immune system is the …

Continue Reading →
Illuminating the role of epidemiology
Volume 1 Issue 3

Illuminating the Role of Epidemiology in Real World Research

Epidemiology is a field of science that studies the occurrence of disease in the general population in relationship to the characteristics of individual subjects and …

Continue Reading →
The era of pharma and biotech
Volume 1 Issue 3

The Era of Pharma and Biotech Outsourcing is Here to Stay

Over the past ten years, more and more pharma and biotech companies have turned to CROs, CMOs and CDMOs to assist in the preformulation, development …

Continue Reading →
An efficacious anthrax vaccine
Volume 1 Issue 3

An Efficacious Anthrax Vaccine Based on a Recombinant Protein

The US government has prioritised the development of next-generation vaccines targeted at anthrax that will provide improvements over the currently licensed vaccine, produced from filtered …

Continue Reading →
Harnessing the power of epigenetics
Volume 1 Issue 3

Harnessing the Power of Epigenetics in Precision Medicine

Epigenetic discoveries and innovations may advance personalised medicine well beyond the realms of the genome, bringing hope for many people living with life-threatening and debilitating …

Continue Reading →
The fascinating world of bacteria
Volume 1 Issue 3

The Fascinating World of Bacteria: Pharmaceutical and Cosmetic Applications

Our environment is the niche of billions of bacteria, forming a real ecosystem. Some of these microorganisms are essential contributors to human health. Our body …

Continue Reading →
The importance of testing for pyrogens
Volume 1 Issue 3

The Importance of Testing for Pyrogens in Raw and In-process Materials

Pyrogens are substances that can induce shock, fever or death, with the most common type of pyrogen being the gram-negative bacteria derived Lipopolysaccharide or endotoxin. …

Continue Reading →
Exploring the 505(b)(2) route for
Volume 1 Issue 3

Exploring the 505(b)(2) Route for Systemic and Regional Therapy via Pulmonary Delivery

The Advantages of Using Respirable Engineered Spray-dried Dry Powder Inhaled drug products offer several advantages over other dosage forms, including more targeted drug delivery, which …

Continue Reading →
primary sequence analysis of biosimilars
Volume 1 Issue 3

Primary Sequence Analysis of Biosimilars

Dr Richard L Easton and Dr Andrew J Reason at BioPharmaSpec discuss how the development and production of any protein biologic relies on sound and …

Continue Reading →
Approaches targeting T regulatory calls
Volume 1 Issue 3

Approaches Targeting T Regulatory Cells in Autoimmune Diseases

The immune system has multiple mechanisms to detect and eradicate or neutralise pathogenic microorganisms. However, misguided immune response directed against self, dietary, or environmental antigens …

Continue Reading →
Classification and regulation of advanced
Volume 1 Issue 3

Classification and Regulation of Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) represent a group of innovative pharmaceuticals that are increasingly gaining importance. It combines gene therapeutics, somatic cell-based products and tissue-based …

Continue Reading →
Patenting antibodies at the European
Volume 1 Issue 3

Patenting Antibodies at the European Patent Office

Throughout the world, a key principle underpinning patent protection is that the scope of protection should depend on how the invention contributes to existing knowledge …

Continue Reading →
Digital transformation_optimising the opportunities
Volume 1 Issue 3

Digital Transformation: Optimising the Opportunities in Life Sciences R&D

Intelligent automation offers considerable potential for addressing the R&D productivity agenda, but how can life sciences firms exploit smart new digital options to their maximum …

Continue Reading →
Challenges of small molecule production
Volume 1 Issue 3

Challenges of Small Molecule Production

Over the last 10 years (2008–2017), the United States FDA approved a total of 320 new drugs. Of these, 249 were new chemical entities (NCE) …

Continue Reading →
The cell therapy supply chain and risk
Volume 1 Issue 3

The Cell Therapy Supply Chain and Risk Assessment Considerations

Across the world, patients who once may have had little hope of survival are benefiting from the treatment efficacy and potentially curative potential of novel …

Continue Reading →