Manufacturing
Eliminating Guesswork
Automating PAT PM process control
The words process control as related to Active Pharmaceutical Ingredients APIs production are interesting Process can mean anything from simple singlestep reactions to very complicated chemistry multistep processes and continuous processing while control implies some state of stability and knowledge of the process and process steps Upon closer exam...
Large-scale Biochromatography
What lies ahead?
Upstream productivity in the biomanufacturing industry is not being matched by improvements downstream For processes such as packedbed chromatography that cannot be scaled up indefinitely the future is starting to look bleak Manufacturers around the world are approaching the limits of productivity and scalability and innovative downstream processin...
Single-use Bioprocess Containers
Economics of usage in Asia
Singleuse disposables have become a common name in the biomanufacturing industry world over All major companies related to equipment and filtration products are present in this domain They are increasing their presence by introducing more products in the disposable singleuse format Some of the wellknown benefits are Lower capital investments...
Cell-based Potency Assays
Adhering to GMP standards
A biological measurement of the activity of a drug is perhaps the most critical step in the series of tests required for product release for both clinical trials as well as the market and plays an important role in the stability assessment of drug candidates All drugs require a clearly defined specification for release wherever possible this should...
OEE Systems and Software
Enhancing operational efficiency
Pharmaceutical manufacturers encounter unique demands in their endeavour to manage improvement with operational excellence In the past it was easier for pharmaceutical manufacturers to achieve the desired margins But in the current scenario of competition price pressure stringent FDA regulations and the ongoing economic crisis pharmaceutical manufa...
Developing Robust Approaches to the Effective Characterisation of Biosimilars
Biosimilars also known as followon biologics or similar biological medicinal product henceforth referred to as biosimilars are products that are similar to but not the same as an innovators drug Since they are expected to cost less than an innovators drug they bring affordable alternatives for treatment for patients who previously could not afford...
Validation Projects in China
Between and Pharmadule built a number of pharmaceutical manufacturing facilities in China for both domestic manufacturers and multinational pharmaceutical companies including Eli Lilly and AstraZeneca The multinational companies required GMP compliance and validation services comparable to the level that exist today The facilities delivered for C...
Lyophilisation
Process Development
Freezedrying is used by the pharmaceutical industry for years Its a way to protect sensitive molecules from degradation allowing their shelf life to be extended from days or months to years Moreover the technology is perfectly integrated inside industrial GMP Good Manufacturing Practice production giving a high degree of confidence in product steri...
Similar Biologics
Golden Bird to Tame
In the past three decades biotechnologyled medicines have revolutionised the treatment of several life threatening and rare diseases The substances produced by living cells and used in the treatment diagnosis or prevention of diseases are referred to as biologic drugs or biologics or biopharmaceuticals or recombinant therapeutics Since the approval...
Integration of Packaging Innovations
The role of packaging in Pharmaceuticals has taken an incremental leap in terms of its critical importance as an integral part of a medicine The earlier understanding that packaging is not consumed by the enduser therefore it need not be considered an integral part of the drug is fast fading off Many challenges issues and concerns faced by the glob...
