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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

Innovation at CPhI Worldwide: Duma Pocket – the pharmaceutical packaging that doesn’t look like medicine

Düsseldorf/Frankfurt, October 24, 2017. Patients prefer pharmaceutical packaging that does not give away its contents at first glance. With their oval shape, Gerresheimer’s extremely handy Duma Pocket containers look more like boxes of sweeteners, chewing gum or peppermints. The Duma Pocket is available in many different sizes and colors and with various closures. Gerresheimer is expanding its range of this tried-and-tested packaging with the addition of the 40 ml Duma Pocket CR Box and the 100 ml Duma Pocket CR 100 for large filling volumes.
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White Papers

Analysis of Biopharmaceuticals to Conform to ICHQ6B

RSSL

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%. In 2010 the average medicines expenditure per person within the UK was £271, and this is expected to increase with the ageing population. A significant and increasing proportion of these sales are protein-based biotherapeutics or biomolecules. Currently, these account for 19% of the total market, and are growing at twice the rate of traditional small molecule pharmaceuticals. It is predicted that close to 50% of the top 100 pharmaceutical products will be biomolecules by 2016. By far the largest segment of the biopharmaceutical market is the monoclonal antibody (MAb) with an estimated share of 25.6%, which corresponds to USD 51.1 billion.
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Industry Events

12th Annual Parallel Trade

6-7 February 2018, Holiday Inn Kensington Forum, London, UK

SMi Group is proud to announce the return of Europe’s only Parallel Trade conference. Back for the 12thyear, Parallel Trade returns to London on 6th-7th February 2018.
More info >>

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