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Pharmaceutical Manufacturing and Packing Sourcer |
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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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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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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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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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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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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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News and Press Releases |
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Albumedix announces recombinant human albumin supply partnership with FUJIFILM Wako Pure Chemical Corporation for the Japanese, Chinese and Hong Kong markets
Nottingham, UK – 29th March 2021 – Life Science Newswire – Albumedix Ltd.
(‘Albumedix’), an enabler of advanced therapies and world leader in
recombinant human albumin (rHA), announced today that they have entered
into a distribution agreement with established and well recognized
reagent supplier FUJIFILM Wako Pure Chemical Corporation (FUJIFILM Wako)
in Japan and China including Hong Kong.
More info >> |
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White Papers |
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Comparator Sourcing in Oncology Trials
Clinical Services International
This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics.
More info >> |
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