Pharma IQ Members

Artwork Matters

View All Posts
Andrew Love
In the last article I looked at the starting point of developing your organisation’s strategy, the legislation and its impact. In this article I discuss defining your solution, what to look for when picking your implementation partners and the key aspects to consider when resourcing the project team.
Tags:
May 16, 2016 by Andrew Love
Andrew Love
This article is the continuation of Andrew Love's series of articles on auditing of artwork processes and services. It takes the format of a series of tips to cover different aspects of an artwork services and the some of the issues you should consider if preparing for or undertaking an audit.
Tags: artwork matters | pharmaceutical packaging | Packaging and Labeling | Andrew Love
January 6, 2015 by Andrew Love
Andrew Love
This article is the continuation of Andrew Love's series of articles on auditing of artwork processes and services. It takes the format of a series of tips to cover different aspects of an artwork services and the some of the issues you should consider if preparing for or undertaking an audit.
Tags: auditing pharma artwork | pharma packaging | artwork matters | Andrew Love
December 14, 2014 by Andrew Love
Andrew Love
In this second entry in his series, Andrew Love gives his tips on auditing of artwork processes and services. Like some of his other articles, this takes the format of a series of tips to cover different aspects of an artwork services and the some of the issues you should consider if preparing for or undertaking an audit. This column covers Read more
Tags: Artwork | Process | quality control | pharma packaging | pharma artwork | artwork matters | Andrew Love
November 16, 2014 by Andrew Love

Making Tomorrow's Medicines

View All Posts
Tony Hitchcock
Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and Read more
Tags:
May 10, 2016 by Tony Hitchcock
Tony Hitchcock
When we look at the current trends with what we can refer to as “next generation therapeutics”, whether it be ADCs or cell and gene therapy products, one trend is very clear, products are becoming increasingly complex in their nature. Certainly, the complexity of the manufacturing processes used to produce them clearly reflects this; hand in hand Read more
Tags: manufacturing, pharmaceuticals, pharma, biotechnologies, biotech, biopharma, therapeutics, gene therapy, cell therapies, | disposable manufacturing | vaccinces, | CMOs | pharma firms | Big Pharma | SME pharma | drug developer | Tony Hitchcock | contract development
March 22, 2016 by Tony Hitchcock
Tony Hitchcock
At Cobra we have worked on the development of both naked plasmid DNA and viral gene therapy products for over 20 years. After some rather extended development times, it has been very rewarding to see a number progress out of Phase II clinical studies and customers wanting to take these products into Phase III studies.
Tags: manufacturing | technologies | Tony Hitchcock | processes | DNA | gene therapy | genomics | clinical evaluation | clinical experience
September 21, 2015 by Tony Hitchcock
Tony Hitchcock
With this year’s Disposables Solutions meeting in Munich rapidly approaching I will focus this blog on some of the issues which I hope will be covered in presentations and discussions.
Tags: disposables solutions | Tony Hitchcock | single-use systems | single- use | biomanufacturing
February 8, 2015 by Tony Hitchcock

Market Access, Trends and Outlook

View All Posts
Regina Au
Regenerative medicine or man-made regeneration has been influenced and advanced the most with 3D printing technology. Scientists using stem cells and/or various forms of scaffolding have taken advantage of these technologies in such a short period of time and many different human parts have been reproduced: skin, ears, nose, eyes, bone, and parts Read more
Tags: REgina Au | 3d printing | 3D Printing Biotech
May 15, 2015 by Regina Au

Biopharma Trends and Outlook

View All Posts
Eric Langer
The problem of leachables and extractables (L&E) in single-use devices continues to hound both suppliers and end-users, and remains one of the more challenging issues inhibiting regulatory acceptance of single-use devices.
Tags: leachables | extractables | leachables and extractables testing | single-use devices | Eric Langer | 12th Annual Report and Survey of Biopharmaceutical Manufacturing | biomanufacturing
April 19, 2015 by Eric Langer
Eric Langer
Single-use, disposable bioprocessing reached the Billion-Dollar club this year, and judging by suppliers’ sales growth, it continues to gain broad industry acceptance. The many advantages offered to CMOs and biotherapeutic developers have been well documented.
Tags: single-use | disposable bioprocessing
February 11, 2015 by Eric Langer
Eric Langer
Biopharmaceutical companies that get stuck with legacy technologies, including older stainless steel equipment, and older processes, end up watching as competitors transition to more efficient, cost-effective platforms. In this column Eric Langer breaks down the trends in the biomanufacturing industry and shows that the addition of single use Read more
Tags: biomanufacturing | single use systems | disposable solutions | pharma manufacturing | Eric Langer
October 22, 2014 by Eric Langer
Eric Langer
Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts Read more
Tags: Eric Langer | manufacturing | surve | biopharmaceutical | BioPlan Associates | R&D
December 14, 2011 by Eric Langer

Pharma Industry Excerpts

View All Posts
Tye Spillum
Within the last few years the Pharmaceutical industry has taken a change in direction. Outsourcing (CDMO - external manufacturing model) has become a normal course of business.
Tags: pharma outsourcing | CDMO
September 19, 2012 by Tye Spillum

The Q Pages

View All Posts
Peter Boogaard
But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above? The Quality Transformation is a culture of commitment to continual improvement
Tags: Quality by Design | Peter Boogaard | continual improvement | quality | QbD | ICH Q10 guidelines
February 19, 2012 by Peter Boogaard

Ensuring a Change for the Better

View All Posts
Cristina Falcão
Globalisation’s growth and prevalence of the pharmaceutical market, calls for proactive approaches to manage its risks, namely the size and complexity of value chains and the increased labor market competition. =
Tags: Cristina Falcão | pharmaceutical outsourcing | outsourcing | pharmaceutical manufacturing | offshore outsourcing | In-House CROs | CMOs | contract pharma | contract organisations | insourcing
July 31, 2011 by Cristina Falcão

Risk-Based Implementation of Single Use Systems

View All Posts
Stephen Brown
The deployment of Single Use Systems (SUS) has become a hot topic within the biopharmaceutical industry. From its origins in filtration technology and blood containers, the technology has developed rapidly. In the last couple of years and in response to end-user demand, all of the major suppliers have improved their capabilities and technology Read more
Tags: Stephen Brown | single use systems | SUS | downstream bioprocess | single-use system | SUS Implementation Plan | disposable solutions | biomanufacturing
June 30, 2011 by Stephen Brown