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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Summer 2020

   
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Parenteral Technology Supplement
Has COVID-19 Altered the Drug Delivery Sector Forever?

John Vasilakos and Lisa Dick at Kindeva Drug Delivery

Recently, we’ve had a lot of discussions internally at our company about the overall regulatory strategy for one of our specific types of technologies. I think in having these discussions with a lot of the pharmaceutical and biotechnology companies – especially the smaller companies – there’s a lack of clarity regarding the regulatory path that some of these companies should take. For example, many of these companies think devices and drugs are each single products, but really, they should be considered as combination products. When considering the regulatory path, you have to consider that these two items are going to be used together. The regulatory processes you would take would very much depend on how you wanted to market the product. Also, one must consider if the drug and device are going to be packaged together or separately. There are a number of different options, and how one markets the product at the end of the day is very much dependent on that regulatory path.

 
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Adopting Connected Drug Delivery Devices

George I’ons at Owen Mumford Pharmaceutical Services

Against the backdrop of an ageing population and a rise in non-communicable diseases, digitally transforming the healthcare system is essential. Even before the current world health crisis, healthcare systems were feeling the strain due to increasing demand, which was placing more pressure on resources. If patient self-management and teleconsultations are not systematically developed and expanded, hard-pressed health services around the world will struggle to withstand the pressure.
 
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Longer-Lasting, Safer Syringes

Mitsubuishi Gas Chemical

Mitsubishi Gas Chemical (MGC) is a leading company in the field of oxygen barrier and absorbing technologies. Our special polymer, Nylon-MXD6, has been used for the middle layer of multilayer beverage bottles for many years to prevent oxidation and carbon dioxide’s evaporation of beverages. Additionally, our oxygen absorber, AGELESS®, has been used for IV solutions and pre-filled syringes to prevent oxidation of injectable drugs for more than 30 years.
 
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Choosing the Right Packaging

Cecilia Bassi at Bormioli Pharma

Packaging is a critical factor of success for parenteral medicine. In fact, packaging and drug formulation actually must go along in terms of development, and choosing the right container for a drug is all but an easy task. This is true in the pharmaceutical industry in general and, above all, when it comes to parenteral drugs.

Parenteral dosage forms differ from all other drugs because they are injected directly into the tissue through the primary protective systems of the human body, such as skin and mucous membranes.
 
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Combination Products: Common Use Errors and Design Considerations
 
Richard Featherstone and Linda Giesselink at Emergo by UL

Combination products, such as injection devices, inhalers, nebulisers, and drug patches, are increasingly being used by laypeople for self-administration at home. Regulators such as the FDA and the EMA want to ensure that all users – and laypeople in particular – can administer the correct dose at the right time to the right part of their body. Manufacturers have a responsibility to predict likely use errors and, wherever possible, to ‘design out’ the error such that the user automatically uses the product as intended. Designing the user interface such that use error is impossible, or unlikely, is the preferred and most effective approach to reducing use-related harm. The weaker alternative is to rely on instructions and training to avoid use errors; labelling and training are also valuable risk mitigations but should not be the primary ones.
 
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Enhancing Parenteral Packaging Security

Dr Liliane Pfeiffer at Schreiner MediPharm

Thanks to the EU Falsified Medicines Directive that has been in effect since February 2019, tampering with secondary medicine packaging has become more difficult. But, what about primary containers such as vials and syringes or autoinjectors? They continue to be exposed to the risk of tampering although first-opening indication for patient protection would be particularly important in these cases: a security gap that specialty labeling solutions and concepts can close.
 
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Feature topics
Strengthening Supply Chains with Graph Technology
 

Amy Hodler at Neo4j
 
 
Pharmaceutical, biotechnology, nutritional, and medical device industries have seen massive disruption. In many cases, supply chains have not been flexible enough to adapt to product shortages and increased demand for new substances and devices in the pandemic. Manufacturing and packaging operations that have been fine-tuned for efficiency over many years face requirements to pivot to new products almost overnight. Too often, understanding and changing complex data interdependencies in traditional structured query language (SQL) databases can delay the pace of change.
 
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Bearing Obsolescence Management

Chris Johnson at SMB Bearings

While the origin of the first bearing is unknown, Ancient Egyptian drawings depict tree trunks under sleds with liquid-lubricated runners used to move massive stone blocks. While not as old as Ancient Egyptian bearings, some bearings in use today may have been produced decades ago. So, what happens when manufacturers stop producing a certain type?

 
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Pharmaceutical Labelling
Packaging’s Data Evolution

Rob Ellinor at Domino Printing Sciences

The concept of product packaging has evolved from humble beginnings as a plain, loose wrapper, to a sophisticated, branded, and data-marked means of providing critical information throughout a product’s supply chain lifecycle.


 
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Cracking the Code Mark in Pharma Labelling

Richard Pether at Rotech Machines

Pharmaceutical labelling has always been a key part of a product’s integrity. The label carries vital information on the drug type and strength, as well as traceability information printed onto the label at the point of packaging.

 
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Hand Sanitiser Labelling and COVID-19 Interim Regulations

Alison Senyi at Nexreg Compliance

The current coronavirus (COVID-19) pandemic has had a global impact on people’s health and well-being. In the fight against the virus, the importance of using hand sanitisers and surface disinfectants has become the focus towards preventing and eliminating the spread of the virus.
 
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Practical Tips to Navigate the New Normal

Gurdip Singh at Kallik

The life science sector is in a period of unprecedented transformation. Pharmaceutical manufacturing and packaging businesses have responded swiftly to requirements to pivot their business, producing and packaging new drugs and devices. This is in the context of unparalleled disruption to the supply chain.
 
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Packaging Potent Products
The Trend Towards Continuous Improvement

Fabian Stöcker at SCHOTT

Fabian Stöcker: I think there has been a lot of innovation, particularly in the last five to seven years. One major trend in packaging is that it was previously offered in what we would call a ‘bulk format’, this means the packaging was not washed or pre-sterilised. Now, we are seeing improvements in the supply chain.
 
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Achieving Zero Defects in a Pandemic

Massimo Mainetti at Datwyler

As the COVID-19 pandemic continues to unfold, the industry is working tirelessly to identify an effective treatment and vaccine. Amid the pressure to produce a vaccine in such a short time frame, there is also the pressure to ensure no valuable time and resources are wasted. Naturally, treatments that are being considered are large molecule drugs, which require manufacturers to address challenges with achieving zero defects and silicone contamination stemming from packaging and delivery.
 
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Making Progress Toward Sustainable Packaging

Martina Christiansen at Hoffmann Neopac

If any phrase can be aptly applied to these uncertain times, it is ‘safety first’. We used to say it to our children playing outside; now we say it to ourselves as we remain inside.
 
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COVID-19: The Effects on the Supply Chain
Nutraceuticals to See a Post-COVID-19 Immunity Boom

Dominique Baum at AYANDA


The economic impact caused by COVID-19 has been felt globally. With non-essential businesses temporarily closing down and consumers being more conservative with their money than ever before, spending is at an all-time low. However, according to data from Euromonitor’s national stock-out reports, it is clear that demand has been growing in the nutraceuticals space, and in particular, for immunity formulations.

 
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Counterfeiting in the Time of COVID

Mike Isles at ASOP EU and Marietta Ulrich-Horn at SECURIKETT

The demand generates the offer. Where there is an acute lack of protective equipment, testing, and medication in the fight against the coronavirus, product fraud is growing rapidly. Even in exceptional times such as these, criminals do not shy away from putting counterfeit and inferior goods into circulation, directly putting the public, healthcare workers, and patients in harm’s way.
 
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Smart Indicators for Time and Temperature in Healthcare

Nora Murphy at Timestrip

The coronavirus pandemic has brought into sharp relief a number of issues in the healthcare and medtech sectors, which were perhaps less well known previously. Among these is the monitoring of temperature and storage time on products that have a defined shelf life, or are most sensitive to their environment – everything from biological specimens and pharmaceutical products to the humble hospital curtain. Greater sensitivity to infection issues means that today’s healthcare professional needs to consider best practice in the deployment of disposable indicators for time and temperature.

 
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How Have Pharma Supply Chains Coped During the Pandemic?

Manuel Leal Sánchez at Idifarma, Tony O’Sullivan at ChargePoint Technology, and Sascha Sonnenberg at Sharp Clinical Services

The health crisis created by COVID-19 has shaken the pharmaceutical industry and the whole world. This is forcing many companies to rethink their supply chains in order to reduce their dependence on suppliers of raw materials and finished products from distant countries. Companies are instead opting for manufacturers that are typically closer and can guarantee supply in critical conditions.

 
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Collaboration in Pharma
Responding Better to Supply Chain Distribution

John Bermudez at TraceLink

The COVID-19 pandemic has highlighted critical weaknesses in the global pharmaceutical supply chain. These pain points have illustrated that it is more important than ever for pharma companies to look beyond their ‘four walls’ and seek new solutions and digital infrastructures to address these challenges.

 
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Synergistic Relations

Fran DeGrazio at West Pharmaceutical Services, Inc

In this fast-paced and complex technical and regulatory environment, pharmaceutical and biotechnology companies are looking for new ways to become more efficient while building processes that deliver new drugs to market in a timely, cost-effective manner.


 
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From Manufacturing to Supply

Randy Peoples at DHL and Ira Smith at Peli BioThermal

The rise of industry concern about green initiatives has been growing for decades. This has had an impact on how individual citizens view their own decisions regarding their actions, the policies of their governments, and the actions of companies they patronise.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

PharmaFluidics awarded VLAIO research grant

Ghent, Belgium – June 2, 2020 PharmaFluidics NV, innovative player in the field of analytical chromatography with its unique high-resolution µPAC™ micro-Chip technology, announces that it has been awarded a € 613 k grant from Flanders’ Innovation & Entrepreneurship Agency (VLAIO). The grant will run over two years and will support the further optimization of PharmaFluidics’ manufacturing flow, and to develop complementary new surface-modified µPAC™ products.
More info >>

White Papers

Translating Cancer Genomics Into A Personalised Approach For Cancer Patients

PRA Health Sciences (PRA)

Over the past few decades, the approach to prevention, diagnosis and treatment of cancer has radically shifted from organ-based to morphology-based and most recently, to genetics-based. Personalized or precision medicine (tailoring a treatment for a patient’s particular disease at a precise time point) is being performed every day at different levels in the clinical setting.
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