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Pharmaceutical Manufacturing and Packing Sourcer |
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Industry Insight
PMPS Industry Advisor Robert Harris discusses today's global supply chain logistics challenges in pharma, and how biologics have come to take a greater share in the pharmaceuticals market.
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Pen and Auto-Injector Production
Springing to Life
Dr Tolga Goren of BAUMANN Springs investigates the growing role of springs in medical pens and auto-injectors. What are the development challenges that face a manufacturer of this small, yet essential, part of such an important device?
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Parenteral Delivery Trends
Packaging Patient Needs
As demand for injection devices increases, so does the number of new solution providers in this field, states Rasmus Renstad at SHL Group. He shares his advice on how to find your perfect partner, and how to give patients exactly what they want.
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Medical Device Identification
Labelled as Safe
The complexities of implementing the FDA’s unique device identifier system into medical device packaging can leave affected companies feeling daunted. Kevin Grygiel at PRISYM ID explains the advantages of label lifecycle management capability.
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Counterfeits Update
Time for Action
Aegate’s Graham Smith reports on the Falsified Medicines Directive and the recently published Delegated Regulation, and considers how implementation will work in practice at each point in the pharma supply chain.
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Serialisation Requirements
Mark My Words
What coding and marking options are available to manufacturers to help fight counterfeiters? Richard Nemesi at Videojet Technologies outlines a number of solutions that can enhance traceability, which in turn will protect product authenticity, consumer safety and brand reputation.
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Cold Chain Management
Logistical Nightmare
Mark Sawicki at Cryoport advocates the use of controlled facilities, dry vapour packaging and tracking to take control of the transport of temperature-sensitive pharmaceuticals for clinical trials.
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Pharma Air Freight
Better Together
Can pharma companies do more to enhance the supply chain? Pelican BioThermal’s Ira Smith believes that greater collaboration between shippers and 3PLs – and, ultimately, formation of a global regulatory standardisation – is key to success. |
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Q&A: Industry Efficiency
Collaboration is King
Mark Blanchard at BioPhorum Operations Group describes to PMPS how stakeholders throughout the pharma supply chain can work together better – by sharing knowledge, rather than adapting an “us versus them” mentality. |
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FlyPharma Event Preview
Pharma Takes Flight
Putting the spotlight on the benefits of collaboration between pharma shippers and logistics service providers, the FlyPharma Conference 2016 offers a great opportunity to network with like-minded industry decision-makers and gain insight into making the pharma supply chain stronger. |
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Device Studies
Responsive Performance
It can be both difficult and expensive for researchers to manage medical device clinical trials. However, Grant Dietrich at Cenduit explains that with the right interactive response technology, it could be made cheaper and more efficient.
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Supply Chain Operations
Waste Not, Want Not
Could Big Pharma’s resistance to change restrict manufacturers’ ability to apply a new, flexible approach to efficiency? Hugh Williams from Hughenden Consulting challenges the industry to be more open to an integrated, end-to-end supply chain.
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Continuous Manufacturing
Keep it Moving
Peter Webster at PCI Pharma Services and Duncan Betteley at S3 Process Ltd offer their views on continuous manufacturing methods as an alternative to batch production – and warn that pharma’s hesitancy to consider this approach causes it to fall behind the levels of progression other industries are experiencing.
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Safe Drug Storage
Kept in Check
Legislation protecting medical products against temperature increases during storage is strict, but necessary to ensure drug integrity. Air conditioning equipment has advanced considerably, but what do you do when things go wrong? Carl Webb at Andrews Sykes Specialist Hire reports.
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End of the Line
Wait and See
Outlining the implications of a possible UK ‘Brexit’ from the EU for pharma, Robert Harris wonders what might happen to the relationship between the EMA and the MHRA, as well as other healthcare bodies.
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News and Press Releases |
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PredictImmune announce issuance of new patent in the US in support of commercialisation
PredictImmune, developers of pioneering prognostic tools for guiding
treatment options and improving patient outcomes in immune-mediated
diseases, today confirmed its latest patent grant in the US. The US
patent is part of PredictImmune’s third family of intellectual property
(IP) relating to methods for predicting autoimmune disease risk. This
follows successful grants across the company’s first family of IP in the
UK and Europe in October 2018 and Canada in January this year.
More info >> |
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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CPhI & P-MEC China
18-20 June 2019, SNIEC, Shanghai, China
CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
More info >> |
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