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Pharmaceutical Manufacturing and Packing Sourcer |
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Industry Insight
Graham Hughes casts his eye over a selection of articles from this issue of PMPS.
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Robotic Innovations
Auto Assembly
Alan Spreckley from ABB observes that pharma manufacturers are finally taking the lead from the food and beverage sector – more and more are implementing robotics in their production processes, and discovering a wide range of improvements.
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Spotlight
Coming Home
US initiative Save Your Factory, set up by FANUC Robotics, argues that moving manufacturing overseas is not always the best option. It believes that the many advantages offered by robotic and automated solutions may well persuade North American companies back to domestic soil.
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Temperature-Assured Packaging
Hot Topic
New design concepts are constantly emerging with a view to improving product and packaging performance and integrity. Liam Holmes from Sonoco Thermosafe considers a recent case study where single-use options were compared to reusable, sustainable solutions in order to achieve greater temperature assurance.
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Ambient Temperature Solutions
A New Profile
Richard Wood at DS Smith Plastics Cool Logistics hopes that a universal formula for developing ambient temperature profi les will revolutionise the temperature-controlled packaging industry, and highlights the need to rely on actual data rather than assumption.
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Regional Labelling
A Common Language
As the trend for expansion into the BRIC countries continues, Vince Postill at PRISYM ID asks whether it is possible to fi nd a global approach to local language labelling for clinical trials?
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Freeze Drying
Lyophilisation: The Truth
Freeze drying is plagued by numerous misconceptions regarding the best way to integrate the process into existing production lines. Katriona Scoffin at Biopharma Technology Ltd walks us through ten of the most common lyophilisation myths.
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User-Friendly Dosage Forms
A Taste of Your Own Medicine
Patient compliance has always been a complex issue, especially with certain groups such as children or the elderly. Overcoming bitter-tasting APIs to create user-friendly alternatives to solid tablets is key to solving this problem, says Detlev Haack at Hermes Pharma.
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Fast Dissolve Formulations
Quick Thinking
A better understanding of tablet structure could prove instrumental to the production of fast dissolve dose forms, and lyophilisationbased formulations in particular should tackle speed of dispersion and palatability issues, claim Rob Travers and Leon Grother of Catalent Pharma Solutions.
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Device Design
Driving Innovation
Drug delivery and medical
devices are playing an increasingly intelligent and customisable role in patient
therapy management. Peter Wallrabe from Gerresheimer item GmbH investigates the
development of a new device from start to finish. |
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Falsified Medicines Directive
Code Word
Manufacturers will be encouraged to implement anti-counterfeiting measures before the European Falsified Medicines Directive becomes mandatory in 2017. Harry Thomason of Travtec emphasises that careful consideration of the way coding is printed on packaging will be crucial to maintain accuracy.
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GDP Guidelines
Temperature Control
Two experts from Intelsius – Alex Roskoss and Stephen Healy – combine their knowledge to provide both scientific and business views on the European Union’s new Good Distribution Practice guidelines, and debate how far these changes will affect supply chains.
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Leak Detection
Break With Tradition
Philip Stevenson at Sepha compares the variety of methods used to detect leaks in blister packaging. He reveals that long-established destructive methods are slowly being replaced as non-destructive options come to the fore.
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Secondary Packaging
All Wrapped Up
Primary packaging concerns are always on the radar of pharma companies when improvements are considered. However, Martin Leeming at TrakRap reminds us that secondary packaging is a key area of innovation which has the potential to deliver huge benefi ts.
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The End of the Line
Emerging Safely
Richard Harrop suggests the best way to go about entering emerging markets with a temperature-controlled product, and highlights the challenges a new competitor might face.
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Clinical Supplies
Keeping it Cool
Emerging markets can provide pharma companies with huge opportunities to cut costs and reach new patients, but Rachel Griffiths at Biotec Services International stresses that these benefits come with many new challenges.
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Q&A: BRIC Expansion
Market Research
Growth into BRIC markets is a hot topic in the pharma industry right now. However, Reenita Das at Frost & Sullivan warns that moving production overseas is not as straightforward as it is often made out to be.
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News and Press Releases |
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Envigo launches PATHWAY an optimized safety assessment solution to enable first in human clinical trials
11 March 2019, East Millstone, N.J. – Envigo, a leading provider of
non-clinical contract research services and research models, announced
today the launch of PATHWAY – an integrated solution that optimizes
non-clinical safety assessment programs to enable first-in-human
clinical trials. PATHWAY is designed to manage the complexity of the
entire safety assessment process on behalf of the company’s
pharmaceutical and biotechnology customers by integrating safety
assessment study types and bioanalytical support with scientific and
regulatory consulting, program design and project management.
More info >> |
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White Papers |
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
DrugDev
With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >> |
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Industry Events |
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INTERPHEX 2019
2-4 April 2019, Javits Center, New York
At INTERPHEX, find all of the State-of-the-Art Solutions you need to
Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier
pharmaceutical, biotechnology, and medical device development and manufacturing
event and sponsored by Parenteral Drug Association (PDA). Dedicated to
Innovation, Technologies and Knowledge, the show focuses on the entire product
development life cycle.
More info >> |
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