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Pharmaceutical Manufacturing and Packing Sourcer |
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Manufacturing Data Management
Data on a Diet
Joe Rothman at Aegis
Analytical Corp applies the Lean philosophy to data and advocates data
warehouse solutions that are focused on process intelligence as a way to
iron out the creases in complex supply chains. |
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Manufacturing Plant Design
Plants with Agility
When considering the design of a new manufacturing plant, it is
important that one also anticipates the ‘future needs’ of the facility.
Wim Spook at Matcon Ltd UK looks at some of the measures to be taken,
from intelligent layout to how to handle a capacity boost. |
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Containment Systems
Think Inside the Box
Maurice Pitcher at Powder
Systems Limited discusses the importance of reliable and efficient high
containment systems in pharma processing and manufacturing, and points
out some essential design considerations that can make for safer and
more streamlined systems. |
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Water Purification
Pure and Simple
Pure water for the laboratory is a
key ingredient in pharmaceutical production. Mark Bosley at Purite puts
forward reverse osmosis water purification systems as an economical tool
for developers. |
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Sustainable Supply Chain
Green Agenda
Supply chain management
technologies are providing pharma companies with stronger green
credentials – as well as improved agility and responsiveness within the
supply chain – thereby leading to financial savings, as Sudeep Kumar
Mandhania at Infosys explores. |
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Temperature-Controlled Logistics
Chain Challenge: Part 2 of 2
Robert J
Hayes of Cold Chain Consultants (UK) Ltd stresses the importance of
avoiding mistakes in the early phases of the cold chain process, and how
temperature excursions can be minimised through effective packaging
solutions and awareness of the most commonly problematic stages.
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Supply Chain Risk
Quality Assured
Highlighting the increasing levels of
risk in today’s logistics and supply chain operations, Luc Huybreghts of
Pauwels Consulting advises on how to ensure product integrity
throughout the process, and which pitfalls a distributor should look out
for |
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Sustainable Packaging Design
Clean Living
Mark Church of Laminar Medica
looks at how the need for businesses to comply with
environmentally-friendly regulations will drive them to embrace these
challenges, thus leading the way to ensure sustainable survival in the
global economy. |
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Nanotechnology Drug Delivery
Thinking Small
With an ever increasing
number of new applications, nanotechnology is becoming a key element in
the drug delivery landscape of the future. Tim Harper at Cientifica Ltd
considers the impact this will have on the market and where the largest
gains will be seen. |
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53 Freeze-Drying Microscopy
Freeze Frame
John G Augustine of Smithers
Pharma Services shows how key data from freeze-dry microscopy can
facilitate the proposal of new lyophilisation cycle parameters,
improving the overall quality of the resulting product.
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Primary Packaging: Glass
Inner Strength
New drugs and sophisticated
production processes have created extensive challenges for high-quality
glass containers. Florence Buscke at SCHOTT Pharmaceutical Packaging
picks out the features new glass products must possess in order to
remain relevant. |
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Biomanufacturing
Get with the Programme
As with any manufacturing
operation, biopharmaceutical production stands to benefit from adopting
a Lean philosophy. Nigel J Smart at Smart Consulting Group analyses
some areas for process streamlining, including training of personnel. |
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Packaging and Labelling: Braille
Raising Information
Duncan Robinson at
Pillbox Design draws out the key issues in Braille packaging design,
giving a breakdown of some of the technological advances in packaging
for blind and partially-sighted people that are modernising the market. |
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Foil-Based Packaging
Selection Pack
Jez Clements at Cambridge Design
Partnership discusses material choice when designing a packaging
solution, pointing out the advantages of using foil, while also
addressing the particular issues that come into play with this option. |
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Blister Packaging
Pack and Blue
Blue dye testing methods for
pharmaceutical blister packaging can ensure a stronger, fail-safe
parameter that can elevate package integrity assurance to new levels, as
Oliver Stauffer of PTI explains. |
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The End of the Line
Exactly What it Says on the Tin
Richard Harrop has
some interesting experiences at the 2012 PDA Pharmaceutical Cold Chain
Management & Good Distribution Practice conference in Berlin. |
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News and Press Releases |
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CHDI Foundation extends collaboration with IRBM to accelerate development of Huntington’s disease therapeutics
IRBM, a global contract research organization (CRO), has strengthened
its position in neurodegenerative disease research following an
extension of its long-standing collaboration with CHDI Foundation, a
nonprofit biomedical research organization exclusively dedicated to
collaboratively developing therapeutics that substantially improve the
lives of those affected by Huntington’s disease (HD).
More info >> |
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events |
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Drug Delivery Partnerships 2019
28-30 January 2019, PGA National Resort & Spa in Palm Beach Gardens, FL
For 23 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies.
Year after year this event brings together top scientists and business development leaders from Biotech, Pharma, Generics, Specialty Pharma and Drug Delivery companies to share, discuss, and collaborate. If you work in drug delivery, commercialization/licensing, med device, formulation, biologics, biosimilars, and similar areas, you can’t miss this event!
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