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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

Crunch Time: The Impact of Serialisation Requirements on Packaging Operations

PCI Pharma Services

The deadlines for including unique product identifiers on prescription drugs is putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the target. Here, we look to the experience of a company that is ahead of the curve for lessons on how to manage and ease the transition to serialisation.

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Migration safe pharmaceutical labels improve patient safety

UPM Raflatac

Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail testing and result in significant launch delays or costly recalls. This white paper presents how pharmaceutical companies can ensure that the final label constructions achieve their business, regulatory and patient safety goals.

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High-tech Packaging for High-tech Medicine

West Pharmaceutical Services, Inc.

As more biologics and biosimilars come on to the global pharmaceutical market, they can and will present unique packaging and containment challenges. For materials that are sensitive to glass or that may require larger-dose volumes or custom configurations, cyclic olefin polymers may offer a solution. These novel materials for drug container closure systems can provide a needed alternative to traditional glass containment systems for advanced therapeutics.

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High-tech Packaging for High-tech Medicine

Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test

Wickham Laboratories Limited

Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.

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Considerations for Choosing the Right Wearable Drug Delivery System

West Pharmaceutical Services, Inc.

For patients with chronic conditions, the use of injectable biologic therapies is on the rise. Biologics, while providing considerable therapeutic benefit, can also present several challenges for both drug manufacturers and patients. In particular, many biologics are highly viscous and others require large doses to be injected slowly over time. This can make it difficult to deliver a consistent dose every time, potentially impacting medication adherence.

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Considerations for Choosing the Right Wearable Drug Delivery System

Stripping the confusion out of PVC curtains... and a new seat range.

Teknomek Ltd

With the ever-growing trend towards modularisation of clean rooms and laboratories; Teknomek have responded with a new range of PVC strip curtains, suitable for use in environments where maintaining clean airflow is critical. This new PVC curtain range includes specialist perforated and electrostatic discharge alternatives to the standard options of clear and polar (-25oC) versions.

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Stripping the confusion out of PVC curtains... and a new seat range.

Maximize the ROI of Your Post-Approval Research

Bioclinica

Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!

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Maximize the ROI of Your Post-Approval Research

Achieve full compliance with tamper-verification pharma solutions

UPM Raflatac

UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive on packaging for prescription drugs and high-risk, over-the-counter medicines. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.

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Achieve full compliance with tamper-verification pharma solutions
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News and Press Releases

Synpromics announces a research collaboration with GE Healthcare to extend the toolbox for production of biologics

Edinburgh, UK, 4th January 2017 – Synpromics Ltd, the leading synthetic promoter and gene control company, is pleased to announce a research collaboration with GE Healthcare to jointly develop customised synthetic promoters optimised for GE Healthcare’s proprietary biopharmaceutical manufacturing platform.
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White Papers

BioT ULT Transporter

BioCision

The growth of biobanking, cell therapy, and complex biopharmaceutical therapies like cancer vaccines has created a strong need for products and processes to ensure the stability of temperature­-sensitive biospecimens. Proper collection, handling, characterization, packaging and shipping of these materials is critical, as poor sample handling impacts researchers working on discovery with patient samples, as well as clinicians treating patients with cutting edge therapies. This white paper describes in detail the BioCision BioT™ ULT Transporter, the first-of-its-kind dry ice-based portable cooling system that maintains a stable -75° to -50°C environment for over 24 hours on one charge of dry ice, enabling reliable handling and transfer of valuable temperature-sensitive biospecimens as part of a larger cold chain standardization process.
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Industry Events

INTERPHEX 2018

17-18 April 2018, Javits Center, New York, USA

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA).
More info >>

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