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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

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>


White Papers

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.
More info >>


Industry Events

BIO-Europe 2018-24th Annual International Partnering Conference

5-7 November 2018, Bella Center Copenhagen, Denmark

The 24th annual BIO-Europe® event is the largest biotechnology partnering conference held in Europe. Over 4,000 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.
More info >>

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