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Pharma Focus Asia Magazine

Foreword

Biosimilars and Biologics

Opportunities for blockbuster growth

The COVID pandemic has impacted many industries alike and the impact on biosimilars market was no different Lockdowns causing short fall of resources delays in clinical trials slowdown in FDA approvals of nonCOVID drugs have influenced the RD activities and the biosimilars pipeline

Information Technology

CYBER-PHYSICAL SECURITY TOOL FOR CONTINUOUS PHARMACEUTICAL MANUFACTURING PROCESS

Over the years there have been many expensive and notorious incidents that have prompted the necessity of cyberphysical security of manufacturing plants Stuxnet Duqu Flame and Gauss were malware specifically designed to target industrial control systems ICS and cause physical damage to the equipment and inhibit processes from executing normally

Manufacturing

Predicting Quality Risks in Pharmaceutical Production

Incorporating internal and external signals

Proactive quality risk management provides numerous advantages to pharmaceutical companies such as less rejected batches and less drug shortages FDA a It helps to minimise and predict potential negative impact on patients caused by quality issues and it encourages manufacturers to adopt suitable continuous improvement programs

Applying PAT to the Continuous Digital Biomanufacturing of Monoclonal Antibodies

Monoclonal antibodies mAbs are the highest selling class of biologics due to their specific action and reduced immunogenicity As the use of mAbs promotes treating many diseases eg cancer with better targeted immunological approaches the development of mAbs will continue to increase

Formulation and Evaluation of Solid Dispersion Containing Simvastatin

Solubility is an important physicochemical factor affecting absorption of drug and its therapeutic effectiveness The poor aqueous solubility of drugs is still now a challenge in formulation and development Due to the poor aqueous solubility the dissolution as well as bioavailability decrease which may be insufficient

Chiral Chromatography in Pharmaceutical Analysis

Advances and applications

Polysaccharide derivatives are extensively used in chiral stationary phases They provide multiple advantages including broad enantioselectivity better resolution ability easy availability and high loadability under preparative separation conditions Commercially available chiral stationary phases CSPs of this type are usually coated onto a silica ma...

Research & Development

A New Strategy to Predict Neurovirulence Risk Associated with Covid-19 Vaccines

For seamless adoption

Vaccines derived from live attenuated viruses are required by law to be subject to tests for residual neurovirulence before use This applies to vaccines which comprise whole neurotropic viruses vaccines which have a neurotropic component or those which have been passaged in neural tissue

Strategy

Current Trends in Regulatory Outsourcing Models

Pharmaceutical companies of all sizes are increasingly outsourcing elements of the development process including regulatory affairs This helps them to access specific technical regulatory or geographic expertise to flexibly augment staffing levels without adding to headcount and to deliver key operational outputs enabling internal staff to focus on...

BIOLOGICS AND BIOSIMILARS MARKET

Key trends in 2021

The first Biosimilar was approved in the year in the European Union and since then there have been more than biosimilar drugs that have been approved Not surprisingly there has been phenomenal growth in the biosimilars market an Assocham report states that the global biosimilars market is estimated to reach US billion by while the Indian biosimi...

COMBINING SAFETY AND EFFICIENCY IN RECONSTITUTED DRUGS IN THE FAR EAST MARKETS

Can advanced dual-chamber solutions help?

Latest figures show that China is the second pharmaceutical market in the world after the United States with an overall value amounting to about billion dollars in

PRACTICE MAKES PERFECT

Adopting industry best practice requires three critical skills

Every life science company is eager to find and absorb industry best practices and for good reason In a business environment that is changing quickly no firm can afford to be left behind and relying on internal experience and lessons is too slow It is essential to imitate as well as to innovate

Advertorials

ARAGEN

A trusted partner

One of the biggest challenges confronting pharma and biotech companies globally is the everincreasing RD costs to bring new drugs into the market The regulatory approvals are also getting more stringent which stretches the overall time required for new launches

ClinPro RESEARCH EMPOWERING SOLUTIONS

Your CRO partner for effective Drug Development in India

ClinPro Research established in Feb is an ISO certified fullservice capability CRO headquartered in Mumbai India We cater to the clinical requirements of both domestic and international pharmaceutical companies biotech companies medical device companies ayurvedic and nutraceutical companies with our exceptional suite of solutions which includes e...

Novo Nordisk Pharmatech A/S

Ensuring Quality Assurance

In the highly competitive pharma market quality has become the key differentiator for almost all products and services Quality control is essential for building a successful business that delivers products that meet or exceed customers expectations

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