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eBook Series

15-1-January-eBookPublished electronically as registration required PDF downloads, the eBook platform affords BPI the opportunity to educate the industry on cutting- edge scientific themes that are currently or will soon be impacting and changing biopharmaceutical development. Limited sponsorship with qualified lead generation ensure excellent investment return.

January 2017: Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Specialty Devices An introduction on aseptic processing explores why fill and finish of both liquid and lyophilized drug products is so often outsourced. Sections follow on traditional container–closures (vials and ampules); prefilled syringes; injection pens, cartridges, and other specialty devices; and trends such as automation and serialization.

March 2017: Extractables and Leachables: Standardizing Approaches to Manage the Risk Single-use technologies bring concerns over extractables and leachables. Risk assessment addresses their probability of migrating into products. Sup-pliers provide “generic” information, but sponsors must perform their own evaluations. Regulatory and industry experts would like to see standardized testing. But how close are we to making that a reality?

May 2017: BPI Lab: Essential Technologies Behind the Scenes of Biopharmaceutical Development Many analytical methods and technologies used in pre-clinical development have important roles in commercial development including process characterization, quality assurance and control, clearance, validation, and other laboratory functions.

July/August 2017: Emerging Countries The biopharmaceutical industry is maturing to global significance. What once was the purview of Europe and North America is now the growing business of other countries. Some are emerging into prominence: e.g., China, India, Singapore. This publication examines what it takes for such countries to succeed: a commitment to quality, innovation, IP protections, and GMPs.

September 2017: Postapproval Strategies Biomanufacturers may need to make changes to approved processes as they gain experience in commercial manufacture and testing (or as regulatory expectations evolve). Some changes require health authority review and approval; others don’t. Risk assessments and data gathering help preclude adverse impacts to product quality, safety, or efficacy. This publication addresses strategies for such continued improvements.

October 2017: Noninvasive Delivery Biopharmaceutical delivery is mostly limited to injections/infusions. Less invasive approaches could improve patient compliance and safety/ efficacy. But challenges come with oral, transdermal, nasal, pulmonary, and ocular routes of administration. To present the state of the art, this publication reports on a February 2017 interdisciplinary meeting organized by the Catalent Applied Drug Delivery Institute (CADDI).

November 2017: Bioprinting 3D printing (“additive manufacturing”) holds great potential for cell and tissue therapies. But it may also lead to innovations in drug product testing and process development. 4D printing introduces the dimension of time through “smart” variations based on temperature, moisture, light/energy, stress, and so on. This publication explores current and future applications.