ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
Craig Morgan believes as stakeholders are increasingly aware that better study start-up (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
SCALE-UP & MANUFACTURING – Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
Craig Morgan believes metrics are indeed critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages.
TECHNOLOGY-ENABLED HEALTH – Digitally Connected Health Technologies: Blazing Meaningful Trails in Healthcare
Daniel Spors and Kyle Dolbow, PhD, say the overall digital health market is currently $76 billion, and is estimated to grow at 21%, and this space includes life sciences and medical device companies that are incorporating digital technology into their products and services, such as smart inhalers and remote therapy devices.
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
EXCLUSIVE ONLINE CONTENT
Thermo Fisher Scientific Inc. recently announced its intent to open multiple Global Customer Solution Centers. The new Global Customer Solution Centers will focus on meeting and exceeding the demands of scientists in food, beverage, pharmaceutical and biotech laboratories by developing critical workflows and integrated solutions that help advance chromatography and mass spectrometry worldwide.
Evonik Completes Multi-Million Dollar Expansion of its CMO Capabilities for API & Advanced Intermediates
Evonik, a global CMO leader for API and advanced intermediates, recently announced the completion of a €36-million expansion of its contract manufacturing capabilities in the US and Europe.
PAREXEL Advances Patient-Centric Drug Development With Introduction of its Patient Innovation Center
PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access.
Metrion Biosciences Limited and AMRI recently announced they have signed a new collaboration agreement. The alliance will promote Metrion’s electrophysiology and ion channel screening expertise to global pharmaceutical and biotechnology clients.
SunGen Pharma recently announced it has entered into a Manufacturing Agreement with Grand River Aseptic Manufacturing (GRAM) to manufacture generic injectable pharmaceutical products.