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Pharma Manufacturing practices include all methods that are required to develop Pharma services. These practices provide minimum requirements that must and should be met by pharmaceutical companies in order to provide high-quality products that will pose no risk to the patients/consumers at large. Pharmaceutical contract manufacturing process involves Pharmaceutical machinery, drug manufacturers contracting a firm for finished products or components. It can be seen as a type of outsourcing. Organizations succeed by focusing on what they do best to their consumers, partners or outsourced vendors. Contract manufacturing seems to fit neatly into this scenario.

Mathematical Modelling of Gene Expression

A toolbox for treatment design targeting modulation of gene networks dynamics

Despite all recent advances of molecular biology and imaging techniques treatment designs based on pharmaceuticals still need enhancement to improve prognostics of patients while reducing the severity of side effects

Proposome, an Efficient and Safe Topical Formulation

Topical delivery is the most acceptable route for treating skin conditions as it provides localized and fast effects


Current situation and future perspectives

As a rule of thumb in epidemiology the world faces a pandemic once every years The previous one was the Spanish flu in At the end of World War I a new strain of the influenza virus HN broke out in the United States

St.Gallen OPEX Benchmarking for Pharmaceutical Manufacturing Sites

Measure yourself against the best but do it right

Compared to other industries the history of OPEX in the Pharmaceutical Industry is a relatively short one Friedli Werani Starting in the early s pharmaceutical companies began to introduce OPEX methods and tools because of rising cost pressure the productivity crises in RD and the end of the traditional blockbuster business model

The Link between Plant Performance & Maturity

Seeing the whole picture

Pharmaceutical plants are increasingly concerned with improving their respective maturity The numerous initiatives are labelled with terms like lean maturity assessment and improvement Quality Management Maturity Improvement etc What is less clear though is if this will have a visible impact on the performance

Biologics to Open New Revenue Streams for Indian Pharma

A leader in generic drugs production India has emerged as a generic hub in recent years Now biotechbased drug development and production is also taking rooting in India

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...

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

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

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

Identifying Routine and Challenging Clinical Pathogens with MALDITOF MS

Clinical microbiology research plays a vital role in improving the diagnosis of infectious diseases drug guidance hospital infection control and antimicrobial drug management Traditional biochemical identification methods are relatively complex and cumbersome and cannot fully meet the requirements of turnover time sample diversity and identificatio...


A potential approach to address bottleneck issue of drug resistant cancer

Cancer is characterised by unrestrained growth of abnormal cells which have potential to alter genome dynamically Invasion of nearby tissues and ability to metastasise by such cells hamper the normal biofunction of healthy cells

Future of Pharmaceutical Manufacturing

The role of Automation

The AsiaPacific pharmaceutical sector is set to grow at a compound annual growth rate CAGR of per cent in the period to Manufacturers wanting to take advantage of these opportunities should stay informed about the latest trends in automation technology


Industrial advancements

Conventional dosage forms and delivery systems present several challenges in treatment of diseases like poor bioavailability high dose frequent administration systemic adverse effects etc

Current Development and Future of Pharmaceutical 3D Printing

The worlds first D printer was invented in the s by using the method of stereolithography SLA After that different types of D printers were gradually coming on the scene

Continuous Manufacturing of Lipid-based Delivery Systems Using Melt Extrusion

Lipidbased Drug Delivery Systems LBDDS are wellestablished pharmaceutical delivery vehicles prepared by developing a stable dispersion of lipidoil and aqueous phase with the help of surfactants and cosolvents to reduce the interfacial tension between the two phases and create a stable biphasic system

Human Vaccine Candidates Discovery and Development on Non-Animal Systems

An adoption with meaningful repercussions

A vaccine is traditionally a biological substance containing a harmless form of the causative organism that causes a particular disease It is usually given to healthy population by injection to prevent the contraction of the disease


Batch manufacturing is the technology platform that is currently used for production of biopharmaceutical products It involves stepbystep processing wherein oneunit operation must finish before commencement of the next operation The mobility between the unit operations is slow as a result affecting the overall productivityBatch manufacturing is the...



The biotherapeutics market is booming Currently annual growth rate of biologics is double that of conventional pharma and is forecasted to grow rapidly Increase in incidence of chronic diseases like cancer diabetes autoimmune diseases genetic conditionsetc and acceptance of biotherapeutics because of their high efficacy and safety are some of the m...


Operating in one of the most demanding and highly regulated environments pharmaceutical companies face the constant challenge of managing medicinal product information for regulatory labelling submissions that comply with regional and national agency requirements

Sustainable Packaging

Pharma to take care of the planet

The top five drivers of this move to sustainability according to the Packaging Sustainability A Changing Landscape report from PMMI The Association for Packaging and Processing Technologies include brand perception competitive pressure environmental advocates topdown company culture and good stewards of the planet

Next Generation Biorepositories for Transformative Medicine

For centuries naturalist collected and curated various flora and fauna from around the world with the idea that these collections would provide important information about natural world Biobanking was started with a similar purpose like collection of biospecimen as an inventory to be utilised for scientific research

SBV Technology and Eradicating the Risk of Contamination in Aseptic Manufacturing

The global CMO Market is growing at a CAGR of per cent between and The growth is attributed to increased outsourcing of generic drugs by Big Pharma companies Additionally medium and small pharma and biopharma companies who do not possess adequate infrastructure will also outsource thereby driving the market Presently nonsterile drug manufacturin...


Measures to promote the use

Healthcare systems in many countries provide universal health coverage which entails a high impact on health system budgets from therapeutic decisions Sustainability demands that clinical judgments be balanced in part by budget restraints


The constant requirement for the targeted delivery of therapeutically active agents has been the key driver in particle engineering and processing within the pharmaceutical industry


Overall death cases from Ovarian Cancer OC accounts to be the highest among different gynaecological malignancies affecting cervix uterus and ovaries



The pharmaceutical industry is undergoing a transformation It is transitioning from a closed internal integrated discovery and development business model generating blockbuster drugs by large pharmaceutical companies to a more open external collaborative model where drug products are more diversified treatments are personalised demand variability i...


Deliberate disordering can improve your strategic marketing planning

In any large life science company strategic marketing planning is a carefully organised timetabled and structured process


Development of a robust control strategy for manufacturing

By the Global Topical Drug Delivery market is expected to exceed more than US Billion


Manufacturing trends offering benefits

In the early st century one of if not the primary goal of a pharmaceutical facility was to maintain large production lines and attain exceptional productivity and product throughput

Drug Substance Scale-up

Impacting successful outcome

In moving a drug substance to commercial scale manufacture chemists face many scalability and processing challenges

Systematic Framework for Implementation of RTD-based Control System into Continuous Pharmaceutical Manufacturing Pilot-plant

Residence Time Distribution RTD is a probability distribution function that describes how long a fluid or powder element spends inside a given operation Currently the Continuous Manufacturing CM is evolving as a preferred platform for pharmaceutical products involving solid dosages forms Therefore the pharmaceutical industries are going through a p...


Spray drying is an important unit operation first patented in Essentially the technique involves the pumping of a solution through a nozzle into a drying chamber where the solvent is rapidly removed by hot gas to yield a dry powder


The key to successfully developing and shepherding a drug to the approval stage and beyond lies in careful planning right from the start of development Any and all issues that may arise during the process should be considered during this planning phase

Dissolution Prediction of Polymer-Coated Multiparticulates using In-Line Process Analytical Technology

Process Analytical Technology PAT is a mechanism for measuring and controlling process performance parameters and Critical Quality Attributes CQAs with the goal of ensuring final product quality Comprehensive implementation of PAT can compensate for process variability within normal operating conditions to ensure process and product quality is mana...


Wet Granulation WG process is a critical step for the production of many pharmaceutical dosage forms During this stage a liquid usually water is combined with a blend of active ingredients and excipients to form homogeneous granules with suitable properties to further processing The establishment of the end point of the wet granulation process i...

Multifunctional Nanoparticles for Check Point Inhibition and CAR-T Therapy

Rational of Reprogramming TumourImmune System The important role of our immune system is to recognise the foreign substance from the healthy cells and eliminate the foreign object from the body while maintaining the normal cells unharmed To do this the body immune cells such as lymphocytes and monocytes utilise unique check point molecules which...


3D Printing opens the doors of possibility for pharmaceutical and medical device industries

Pharmaceutical manufacturers and consumers alike can look forward to a rapid evolution in the way medicine is manufactured and brought to market New possibilities in D printing are opening doors for both pharmaceutical research and applications such as personalised drug dosing complex drug release profiles and even bio printing The implications are...

Residence Time Distribution (RTD) Model

Novel applications to continuous pharmaceutical manufacturing

The Residence Time Distributions RTD can be determined experimentally through the injection of a tracer material into the process in the form of a pulse or a step To achieve this the outlet tracer concentration is measured until the effects of the injection settle down A key aspect to be considered during the experimental determination of resid...

Drug Concentration Assurance of Continuous Tablet Manufacturing

Advanced process control strategy

Currently pharmaceutical companies are going through a paradigm shift from conventional batch to Continuous Manufacturing CM process integrated with advanced automation and control system In CM Real Time Release Testing RTRT can be facilitated by the development of a highly efficient control system that can monitor and correct process variables in...

Pharmaceutical Crystallisation

Emerging process intensification technologies

Solution crystallisation is the formation of a crystalline solid state from a homogeneous solution Different methods exist to create the driving force for crystal nucleation and growth Common crystallisation methods are based on strategies to lower the solubility eg via cooling or the addition of a socalled antisolvent or to increase the solute con...

HPAPI Qualification Testing

Considerations in containment testing

Growing demand for High Potency Active Pharmaceutical Ingredients HPAPI and the rising prevalence of therapy areas such as oncology immunesuppressants and hormonebased products are fuelling the need for high potency handling capabilities As the use of high potency containment systems is rising manufacturers are looking at more innovative containmen...

System Engineering for a Novel Continuous Pharmaceutical Manufacturing Process

Pharmaceutical industries as well as regulators eg FDA are strongly promoting smarter Continuous Manufacturing CM Few pharmaceutical products have been recently approved by US Food and Drug Administration FDA to manufacture in continuous line and several others are on the way There are several advantages but also different scientific challenges for...

Modelling and its Applications in Solids-based Continuous Pharmaceutical Manufacturing Processes

In recent years the pharmaceutical industry has been actively involved in exploring advanced manufacturing processes that can help reduce the manufacturing costs and improve the product quality One of the most promising route is the switch from batch to Continuous Pharmaceutical Manufacturing CPM processes The continuous production mode enables a s...

Safe and Secure

Packaging\\\'s role in combating counterfeit drugs

According to data released by the United States Food and Drug Administration USFDA approximately per cent of all pharmaceuticals sold globally are counterfeit Whilst counterfeiters are active around the world not all markets suffer equally Unsurprisingly the World Health Organization WHO reports that developed nations such Europe and the USA are...

The Rise in Sterile Manufacturing

A focus on containment

Containment is key during aseptic processing and this has led to the development of new transfer methods that are both enclosed and minimise the requirement for operator intervention In this article Christian Dunne global product manager of AseptiSafe at ChargePoint Technology discusses modern containment methods and the advent of split butterfly v...

Cultural Excellence as the Foundation

For effectiveness of the quality system

In pharmaceutical companies it is universally understood that a robust Pharmaceutical Quality System PQS provides key elements of assurance and oversight for pharmaceutical manufacturing and quality control laboratory processes It ensures that patients are provided with medications that are safe effective and reliably produced at a high level of qu...

A Hard Pill to Swallow

Measuring texture in novel oral dosage forms

Oral drug delivery is one of the most convenient and most common methods of delivering medication Its simplicity and costeffectiveness have made it particularly popular with manufacturers in the pharmaceutical industry but it is not always the most popular with consumers The trouble with tablets Traditionally orallyadministered drugs are disp...

Real-Time in- Line Monitoring

For high shear wet granulation

High Shear Wet Granulation HSWG a critical step in many applications in the pharmaceutical industry transforms fine powder blends into more freeflowing granules optimised for solid dosage form production Manufacturers rely extensively RealTime inLine Monitoring For high shear wet granulation on granulation as it can enhance blend uniformity minimis...

A Novel Continuous Pharmaceutical Manufacturing Pilot-Plant

Advanced model predictive control

Continuous Manufacturing CM is evolving into a preferred platform for pharmaceutical products involving solid dosage forms The US Food and Drug Administration FDA has recently approved some pharmaceutical products to be manufactured in continuous line with several others on the way Therefore the pharmaceutical industry is going through a paradigm s...

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