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November 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

M&A Merry-Go-Round

| Charlotte Barker

Round and round she goes, where she stops nobody knows

Manufacture Drug Delivery

Plant Protein Potential

| Stephanie Sutton

Can lettuce really help biopharmaceuticals turn over a new leaf? Researchers who have bioencapsulated blood-clotting factors inside salad leaves as a means to create affordable biologics certainly think so

Manufacture Drug Delivery

Drugs in Disguise

How to dress drugs to help them survive in the bloodstream

Business & Regulation Standards & Regulation

Breaking Bad Language

Can certain buzzwords really sway public perceptions of a new drug?

Discovery & Development Drug Delivery

A Soluble Solution for Drug Delivery

| Stephanie Sutton

Could an ionic liquid–drug system help solve drug insolubility?

Discovery & Development

Herpes vs Cancer

| Stephanie Sutton

A newly approved oncolytic immunotherapy takes on cancer using a live modified herpes virus

Manufacture Business Practice

Nobel Prize for Noble Causes

| Stephanie Sutton

The 2015 Nobel Prize in Physiology or Medicine praises advances in parasitic tropical diseases

Manufacture Bioprocessing - Upstream & Downstream

Exploring the Product–Process Relationship

What comes first – product innovation or process innovation? For biopharmaceuticals, the two should be inseparable.

Business & Regulation Business Practice

What’s in a Name?

Whether you are a global corporation or a tiny biotech, changing your company name is more than updating your letterheads and putting a new sign on the door. Get it wrong and it could be a costly mistake, but get it right and it’s an exciting step towards a whole new image.

Business & Regulation

Treating Before Infection?

Bacterial infection is only treated when we see signs of infection, but what if we could treat earlier and without adding to drug resistance? I’m a believer in the power of endolysins.

Discovery & Development Drug Delivery

Sparking Innovation in Drug Delivery

In an industry as diverse as pharmaceuticals, there is much that different disciplines can learn from each another.

Business & Regulation Contract Development Services

When Outsourcing Goes Astray

“The best-laid schemes o’mice an’ men” often go awry – and that can apply to your outsourcing plans. What do you do if your contractor ends up in the regulators’ bad books?

Business & Regulation Business Practice

The Journey from Chemist to Entrepreneur

Starting my own bioanalytical research company after many years working for Big Pharma has been daunting, but also satisfying, and I wouldn’t have missed it for the world.

Business & Regulation Business Practice

The Realities of a Digital World

Advanced digital technologies are sweeping through the world and changing the way we live our lives and do business.

Business & Regulation Standards & Regulation

The Receptive Regulator

Sitting Down With... Siu Ping Lam, Director of Licensing Division at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)

Manufacture Bioprocessing - Upstream & Downstream

Breaking the Bioprocessing Bottleneck

| Sponsored by GE Healthcare

Battling logjams in downstream processing is a constant challenge, but even when it feels like there’s no room for maneuver, small yet clever steps can help gain efficiency. And sometimes a fresh pair of eyes can find new and surprising solutions.

Manufacture Standards & Regulation

A New Era of E&L Analysis

| Sponsored by ThermoFisher Scientific

Extractables and leachables testing is essential for small molecule and biopharmaceutical products alike, but it can be challenging, especially for companies with less experience

Discovery & Development Business Practice

The application of MicroCal VP Capillary DSC at a contract development organization

This paper provides an overview of the workflow typically associated with preformulation projects at a contract development organization as well as provides a general framework for conducting preformulation studies that leverages the application of biophysical techniques such as DSC and traditional analytics by employing statistical design. A case study involving the formulation development of a monoclonal antibody is presented to detail the utility and potential limitations of DSC in support of preformulation for a variety of protein products.

Discovery & Development Business Practice

Evaluating the rheological properties of hyaluronic acid hydrogels for dermal filler applications

To formulate successfully with HA it is essential to understand the impact of factors such as molecular weight, molecular structure, concentration and degree of cross-linking on rheological characteristics such as viscoelasticity which are directly linked to aspects of product performance. Linking structural characteristics to product performance, via rheological properties, supports smart, fast, and effective formulation. The following study shows how rheology and particle size measurements can be used to characterize the physical properties of HA dermal fillers.

Discovery & Development Business Practice

Application of microcalorimetry in drug discovery at Exelixis

In this report, we illustrate the utility of calorimetry in making better laboratory decisions. Examples will include improved protein construct selection for scale-up; direct measurement of the effects of mutations and post-translational modifications on protein stability; rapid optimization of solvent formulation; direct measurement of substrate and inhibitor binding affinity; determination of the mode of inhibitor binding; characterization of protein-protein interactions; and improved structural biology efficiency, when used in conjunction of other biophysical methods.

Discovery & Development Business Practice

Contribution of variable domains to the stability of humanized IgG1 monoclonal antibodies

Temperature-induced unfolding of three humanized IgG1 monoclonal antibodies and their Fab and Fc fragments was monitored by differential scanning calorimetry at neutral pH. With some exceptions, the thermogram of the intact antibody presents two peaks and the transition with the larger experimental enthalpy contains the contribution from the Fab fragments. Although the measured enthalpy was similar for all three Fab fragments studied, the apparent melting temperatures were found to vary significantly, even for Fab fragments originating from the same human germline.

Manufacture Business Practice

Targeting protein/protein interactions in drug design

Protein/Protein interactions define a large fraction of the validated targets for drug development including cancer, inflammation, diabetes, osteoporosis, infection and autoimmune diseases. Until now Protein/Protein interactions have been disrupted or replaced by other proteins. For example, antibodies or chimeric constructs are used to inhibit ligand/receptor interactions, and recombinant proteins are used as substitutes for deficient or insufficient natural proteins. The use of small molecules as antagonists or agonists of protein/protein interactions is still in its early days. The successful targeting of protein/protein interactions requires a precise characterization of the protein partners, their interaction and the allosteric consequences of that interaction. As illustrated in this chapter, Microcalorimetry is ideally suited to perform this characterization.

Other issues of 2015