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Backward Thinking

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.

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Novo Nordisk Pharmatech A/S signs distribution agreement with DKSH for twelve countries in Asia Pacific.

Novo Nordisk Pharmatech A/S

Novo Nordisk Pharmatech A/S and DKSH, have partnered to provide high-quality cGMP quaternary ammonium compounds in twelve countries across Asia Pacific.

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RSSL introduces same-day mycoplasma testing service in UK

RSSL

Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global biopharmaceutical, pharmaceutical, and biopharmaceutical sectors, has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines.

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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.

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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Streamlining patient recruitment using EHR data

The field of (bio)pharmaceutical research is booming. Increasingly more innovative therapeutics are being developed with the ability to drastically improve the quality of life of millions of patients around the world. Rigorously testing each of these candidate drugs for their safety and efficacy is an essential part of the development process. As the number of clinical trials steadily increases, the search for patients who present a specific medical profile and are willing to participate intensifies.

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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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News and Press Releases

Sustainability, plastics and Brexit: Keynote speakers set to inspire at PPMA Total Show 2019

Experts from IKEA, the British Plastics Federation and The Sunday Times to create a forum for education, knowledge-sharing and debate
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White Papers

Technology Solutions - Driving efficiencies, quality and operational excellence

Worldwide Clinical Trials Ltd

Clinical trials involve the entry, analysis and reporting of millions of pieces of data; year-on-year, the amount of data required to manage efficacy and safety increases exponentially. Recently, solutions available to support this activity have grown in numbers and complexity. The rise of Tablets and Smart Phones combined with the growth of Cloud or SAS solutions has resulted in the technology landscape required to support complex, global studies becoming more confusing.
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Industry Events

CPhI Worldwide

5-7 November 2019, Frankfurt, Germany

Join the World's Largest Pharma Event As it Celebrates its 30th Anniversary! Taking place from 5-7 November 2019 in Frankfurt, Germany, the event will bring together more than 45,000 visiting pharma professionals from around the globe and over 2,500 exhibiting pharma companies from every stage of the pharmaceutical supply chain - from ingredients and machinery to outsourcing services, packaging and more!
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