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Autoinjector testing made safe efficient and flexible

ZwickRoell

The autoinjector market is one of the fastest growing markets across almost all pharmaceutical applications. Studies expect a global market volume of approximately USD 2.5 billion by 2020, with pre-filled autoinjectors representing the largest market segment. There are a variety of tests that can be performed on autoinjectors, and these are well-demonstrated by the Zwick product portfolio. The Ulm-based company and specialist in testing systems offers a variety of testing systems that are already being successfully used by multiple pharmaceutical companies.

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Recommendations Sourcing Human Biospecimens

BioIVT

The foundations for protecting human research subjects come from the ethical principles surrounding the Belmont report : Respect for persons, beneficence, and justice. The use of human biospecimens in research supports these principles with legal and ethical regulations - the most important of which is permission.(1) This permission may come directly from the donor or granted by others with authorization to protect the interests of biospecimen donors.

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Recommendations Sourcing Human Biospecimens

Digital Transformation of the Cold Chain

Sensitech EMEA

The Life Sciences cold chain is a seamless and interconnected global network of people, equipment, data and processes that helps to ensure the safety and integrity of our medicines and vaccines. Cold chain logistics spending totaled $13 billion in 2017, an investment designed to protect some $283 billion in Life Sciences cold chain products, growing at 19% annually.1 Sensitech Inc., a part of UTC Climate, Controls & Security, a unit of United Technology Corp., has played an essential part in the Life Sciences cold chain since 1990, providing a comprehensive set of solutions for manufacturers of biologics, prescription pharmaceuticals, clinical trial materials, and over-the-counter drugs. These solutions help to ensure product quality, patient safety, and regulatory compliance while helping to prevent theft and optimizing cold chain performance.

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Digital Transformation of the Cold Chain

The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation

BioPharmaSpec

1. Introduction As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.

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Advantages of Quantitative NMR for the Determination of Relative Response Factors

Novatia, LLC

Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.

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Advantages of Quantitative NMR for the Determination of Relative Response Factors

7 Common Myths about QP Training Debunked: A Guide for Senior Managers

RSSL

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.

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Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.

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Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.

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Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.

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News and Press Releases

c-LEcta signs Europe sales and distribution agreement with VWR for c-LEcta’s DENARASE®

• DENARASE® is now available through VWR’s sales channels in Europe • VWR, part of Avantor, is a leading global provider of product and service solutions to laboratory and production customers • Cooperation harbors the potential for c-LEcta’s product to gain additional share in a highly dynamic market
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White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
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Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
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