Manufacturing

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.

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...

ADVANCES IN SPRAY DRYING FOR THE IMPROVED DELIVERY OF POORLY SOLUBLE DRUGS

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

CLINICAL MANUFACTURING ON TIME AND WITHIN BUDGET

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...

GEP MODELS FOR SCALING UP WET GRANULATION PROCESSES IN PLANETARY MIXERS

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...

USHERING IN THE FUTURE OF PHARMA

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...

Added Costs for Added Protections

The impact of implementing safety features in pharmaceutical packaging and labelling

The global pharmaceutical market is a complex and dynamic industry that is continuously evolving in response to a variety of market influencers The landscape of the pharmaceutical market has changed significantly with the rise of generic drugs and the rapid expansion of mergers and acquisitions Many companies are reevaluating the location of their...

Continuous Manufacturing

Are we there yet?

In US FDA issued guidance document PAT A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance To encourage the pharmaceutical industry to adopt novel manufacturing methods it cited industry resistance as follows the pharmaceutical industry generally has been hesitant to introduce innovative systems into the manu...

Pharmaceuticals are in Good Hands with Turkish Cargo

As Turkish Cargo we have been awarded with IATAs Center of Excellence for Independent Validators CEIV in Pharmaceutical Logistics at our Istanbul hub With this strength we aim to offer our customers the most reliable means of transport As an air freighter speed of delivery wide network and safety are some aspects of our efficiency When it comes to...

The Impact of Implementing Safety Features in Pharmaceutical Packaging and Labelling

Every year over millions of dollars are being spent to develop drugs that not only provide the required patient treatment but are also safe for human consumption in a set of forms With huge investments putin at the stage of manufacturing are companies set to take up equivalent responsibility in following safety standards while marketing them Severa...

Responding to the Needs of an Evolving Industry

In todays competitive healthcare market pharmaceutical and medical manufacturers rely on partners with a deep understanding of not only the industrys challenges and requirements but also of its opportunities and promise for growth The pharma market is everevolving and everchanging Companies have the responsibility to provide the appropriate answers...

Trends in Pharmaceutical Packaging and Delivery

The global pharmaceutical market is evolving driven by greater international regulatory requirements for improved quality as well as local healthcare policy such as the expansion of universal health coverage for Chinas nearly billion citizens launched in its annual spending projected to grow about per cent in both and according to Deloitte rese...

Immunogenicity of Protein Biotherapeutics

The development of recombinant DNA technology has dramatically increased the use of protein biotherapeutics such as antibodies hormones and enzymes These are useful in the treatment of a wide range of diseases including cancerous conditions infections diabetes and rheumatoid arthritis The relative success of these new drugs has stimulated the devel...

Towards the Operationalisation of Production Systems

Simultaneously increasing effectiveness and efficiency

Historic development of contemporary production systems Although the Toyota Production System TPS was developed as a specific production model for Toyotas unique circumstances in the s such as lack of natural resources lifetime employment practices enterprise unions need for an increased variety of products in smaller quantities Sugimori et al Lee...

Innovation Challenges in Manufacturing

Regulatory agencies in charge of protecting the population against health risks have a large burden divided mainly between two large areas The first is a direct consequence of the mission that is to effectively protect the population against health risks across the diverse industrial sectors and activities which might generate risks This implies th...

Modularisation in Biologics Manufacturing

Recent trends and developments

Design construction and installation of complete modular production facilities for pharmaceuticals and biopharmaceuticals have in recent years been widely accepted According to Gilroy and Martini modular construction of a pharmaceutical manufacturing facility refers to construction of all or part of a new or renovated facility built at a remote loc...

Antibody Drug Conjugates in Reducing Disease Burden

Immense Promise with Some Challenges

The global market for oncology drugs has seen a steady growth in recent years with cancer being the leading area of healthcare spending Market estimates show that in the global spending on oncology drugs reached US billion including supportive care growing at a CAGR of per cent in the period from This trend is expected to continue in to wher...

Unlocking the value

PLM solution in packaging and labelling

Effective package management is an increasingly critical capability for pharmaceutical companies Pressure to maximise the potential of current product portfolios due to thin pipelines has now propelled several companies to enhance packaging to add more value to the consumer as well as to reduce Cost of Goods Sold COGS Better packaging brings benefi...

Using Chemometrics in PAT

Investigating data from the process

Industry of today is generating large amount of data Data that comes from raw materials excipients media and the process Most processes consist of a series of operations steps and are also equipped with instrumentations collecting parameters as the process is in operation The chemometrical analysis of the numerous data collected from such processes...

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...

RFID in Pharma

An Asian perspective

RFID in healthcare is a small part of the global RFID market today but it is growing rapidly to become a US billion business by the end of A large part of this will be the tagging of pharmaceuticals for many purposes including RFIDenabled smart packaging that records usage data such as when each tablet was removed These patient compliance monitori...

Superdisintegrants

An economical alternative

Orally disintegrating tablets ODT are an innovative technology which disintegrates rapidly usually in a matter of seconds without the need for water providing optimal convenience to the patient Conventional tablets and capsules pose difficulty for swallowing in patient groups such as elderly children and patients mentally retarded uncooperative nau...

Ultra Performance Liquid Chromatography (UPLC™)

High performance liquid chromatography HPLC has proven to be the predominant analytical technology used in laboratories worldwide during the past plus years One of the primary drivers for the growth and continued use of HPLC has been the evolution of the packing materials used to effect the separation An underlying principle of HPLC dictates tha...

Micro and Nanotechnologies

From R&D to drug delivery

Micro and nanotechnologies will support pharmaceutical companies in their development strategy by providing solutions to Discover new drug candidates and therapeutic pathways Reduce new therapies development time Facilitate drugs launching with adapted delivery systems Provide better treatment performances Extend pharmaceutical products l...

BaychroMAT® CellCount

A platform for online analytical measurements

Biotechnology will continue to experience aboveaverage growth in the coming years The primary reasons for this are the increasing content of biotechnological active substances red biotechnology in drug products and regenerative fuels such as bioethanol or biodiesel white biotechnology which have become commercially attractive in light of the high p...

Pharmaceutical Manufacturers

Embracing Lean Six Sigma

Today pharmaceutical manufacturers are focused as never before on reducing operational costs while ensuring compliance Cost pressures are increasingly acute as many pharmaceutical manufacturers see a dwindling product pipeline as well as greater competition from generics To ensure that their bottom lines remain solid pharmaceutical manufacturers ar...

Anti-Counterfeiting Technologies

What makes them effective?

The fight against counterfeiting tampering and diversion of pharmaceuticals is a global and complex challenge No doubt the traditional definition of drug safety has acquired the additional dimension of drug securityor more precisely security of the supply chain and custody of the chain But consumers accustomed to their governments protecting them f...

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