Library > Technical Papers
Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - Alkermes
22-Apr-2013 -
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
Application note
RECIPHARM: WHY CONTINUOUS AUDIT READINESS IS CRUICAL - Recipharm AB
15-Apr-2013 -
Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
Case study
Increasing Accuracy, Not Costs - Mettler Toledo
11-Apr-2013 -
Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects from retailer shelves. One major pharmaceutical manufacturer came to Mettler-Toledo CI-Vision hoping to reduce the rate of defective...
Technical / white paper
White Paper: Is My Method Still Valid? - SGS
26-Mar-2013 -
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics...
Technical / white paper
ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio
20-Mar-2013 -
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
Technical / white paper
What Makes 505(b)(2) Different? - Camargo
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Research study
Vcaps® Plus capsules: The next generation HPMC capsule for optimum formulation of Pharmaceutical Dosage forms - Capsugel
28-Feb-2013 -
Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issues during the product development.Vcaps® Plus HPMC capsules are made through a proprietary manufacturing process that eliminates the need for gelling...
Case study
VENDOR MANAGED INVENTORY - Recipharm AB
11-Feb-2013 -
VENDOR MANAGED INVENTORYCONTINUED GROWTH IN DEMAND FOR VMI Vendor Managed Inventory (VMI) can be defined as a means of optimising supply chain performance in which a chosen outsourced manufacturer partner is responsible for maintaining their customer’s inventory levels. The manufacturer has...
Technical / white paper
New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier
11-Feb-2013 -
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
Data sheet
Quantify biodistribution, enhance in vivo decisions - Molecular Imaging Inc.
04-Feb-2013 -
Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key advantages over pre-existing methods including:
full 3-dimensionality with tissue and sub-tissue localization
fine kinetics, targeting, binding and clearance pathways can be examined
clinical translatability
isotope multiplexing...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-Jan-2013 -
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
Technical / white paper
Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS
03-Dec-2012 -
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
Insight guide
Analytical Method Development and Validation — A CDMO Perspective - DPT Labs
28-Nov-2012 -
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...
Case study
Smaller pharma companies financially benefitting from CDMO partnerships - Recipharm AB
26-Nov-2012 -
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to market. Find out how risk-sharing practices initiated by Recipharm have made it possible for customers to closely collaborate and share rewards as...
Technical / white paper
INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES - SGS
19-Nov-2012 -
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials.
Technical / white paper
Lyophilized Pharmaceuticals: A Design Space Approach - Baxter
29-Oct-2012 -
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.