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What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.

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What is process characterization?

What You Need To Know About Thermal Shipping Technologies

Temptime Corporation

This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.

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What You Need To Know About Thermal Shipping Technologies

How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction

Temptime Corporation

The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.

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How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction

Using Device Strategy to Drive R&D Productivity

Phillips-Medisize



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Using Device Strategy to Drive R&D Productivity

Managing GxP Environmental Systems to Ensure Data Integrity

Vaisala Ltd



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Managing GxP Environmental Systems to Ensure Data Integrity

High Potency Drugs – from Molecule to Market

PCI Pharma Services

PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30 years’ experience of managing potent molecules, PCI Pharma Services is the logical choice when selecting an outsourcing partner.

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Data Technology as a Catalyst for Growth in the Life Sciences

AIGENPULSE

The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.

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Tabletability, Compactability, and Compressibilty: What’s the Difference?

Natoli Engineering Company, Inc.

To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block of particles or granules into a single tablet can be complicated. That’s where common compression studies can help. This article explains how to develop tabletability, compactibility, and compressibility profiles.

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Tabletability, Compactability, and Compressibilty: What’s the Difference?

R&D to Product: How to Reduce Costly Scale-Up Problems

Natoli Engineering Company, Inc.

When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scaleup and performance of the formulation at production levels. Problems with capping/lamination and sticking/ picking are often first realized when a formulation is introduced to a level of compression required to supply market demand.

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R&D to Product: How to Reduce Costly Scale-Up Problems

Sterile Vials Made of Tubular Glass

Gerresheimer AG

Gx® RTF vials powered by Ompi EZ-fill® enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers.

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Sterile Vials Made of Tubular Glass
 
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News and Press Releases

Fifth Annual Peptides Congress: Registration Now Open

Join us at the forefront of industry innovation at the 5th Annual Peptides Congress, 16-17 April 2018 in London to shape the future of industry discussion. With over 700 peptides in clinical trials and an increasing industry focus on biologics, now more than ever is the time to focus on this revolutionary field!
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White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
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Industry Events

CPhI India 2017

27-30 November 2017, Bombay Exhibition Centre & MMRDA Grounds, BKC

Connect, network and interact with 1,400+ exhibitors at India's largest and leading pharmaceutical event. CPhI and P-MEC India is the gateway for you to meet the movers and shakers in India’s pharma industry to source high quality pharma solutions at the most competitive prices. Register today for free via: gotocphi.com/india2017
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