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Top Stories
The recall was issued because of a defective delivery system; the units affected had possible package leakage.
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Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.
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Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
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PODCAST
Andrew Bulpin, head of Process Solutions Strategic Marketing and Innovation, MilliporeSigma discusses the company's Emprove Program, winner of the 2016 CPhI Award for Regulatory Procedures and Compliance.
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At the 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop, industry and regulatory experts will address current topics related to container closure for device and delivery systems, including the future of delivery devices, biocompatibility testing, best practices in leachables and extractables, supply chain considerations and strategies/expectations to meet current regulations.
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Industry News
A drop in US drug approvals was noted but this trend was not yet seen in Europe.
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The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
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Supplier News
MilliporeSigma's new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.
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GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Bio/Pharma News
Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington's disease in nearly a decade.
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The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.
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SGS (Webcast - 05/24)
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FORMULATION
Design of experiment plays a crucial role in the optimization process of formulation development.
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PEER-REVIEWED RESEARCH
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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QUALITY
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
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ANALYTICS
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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Titration in Early Drug Discovery and Development
Live Webinar: Thursday, March 16 at 10am EDT
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CPhI North America Planning Guide
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Albemarle Corporation's Fine Chemistry Services business has more than 40 years of experience, dedicated to custom manufacturing.
CPhI North America Booth #1259
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Capsugel designs, develops, and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health & nutrition industries.
CPhI North America Booth #2719
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At CPhI North America, Catalent will showcase its OptiForm® Solution Suite and OptiForm Solution Suite Bio, which combine predictive and high throughput screening technologies to identify the most stable and efficient drug form for both small and biological molecules.
CPhI North America Booth #310
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CMIC CMO USA Corporation specializes in the formulation development and GMP commercial manufacturing of solid dosage products with expertise in sustained and controlled release.
CPhI North America Booth #2600
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CordenPharma is your full-service Contract Development & Manufacturing (CDMO) partner for APIs, Drug Products, and Packaging Services.
CPhI North America Booth #2160
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Events
April 24–26, 2017
April 25–26, 2017
May 16–18, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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