06.18.21 -- Patenting Antibodies: The 4 Tactics To Use In 2021 pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
05.11.21 FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
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In this free live webinar, we will provide an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe when developing a vaccine. We will discuss the different packaging characteristics, assess the syringe platform, and present what Stevanato Group can offer to support pharma partners in delivering a safe and effective vaccine.
Featured Editorial
On April 14, 2021, the FDA released a new guidance,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance and shares how to submit public comments for FDA consideration.
04.19.21 How To Navigate Compliance With FDA s 21 CFR Part 11
CUE Biopharma CEO Dan Passeri, JD joins the
Business of Biotech to discuss the development of their Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares how the CUE-100 series of candidates in its pipeline are being developed to address a scourge of HPV-related head, neck, and other cancers. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Kyle Neuman, SAFE Identity
21 CFR Part 11, the FDA s regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?
04.06.21 A Risk Assessment Checklist Of Nitrosamine Impurities In Oral Solid Dose Drugs
Treatment for advanced cases of lung cancer is challenging. Delivery by inhalation is an ideal way to circumvent many of the drawbacks associated with lung cancer treatment.
Attend this webinar to understand the pros and cons of existing therapies and learn why spray drying is a useful particle engineering technique for the manufacture of pulmonary lung cancer treatments.
By Amol Galande, Ajay Pazhayattil, and Sanjay Sharma
Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits.
CMOs Continue To Exceed Sponsor Expectations
By Kate Hammeke, VP of Market Research, Industry Standard Research (ISR)
@ISRreports
We would like nothing more than to celebrate the 10th year of Life Science Leader’s CMO Leadership Awards with our community, in person.
The community that has positively contributed to successful outsourcing partnerships for the past decade by sharing their outsourcing philosophies and practices, the criteria they use to select CMOs, their perceptions and interactions with contract manufacturers, and how the CMOs they have worked with in the recent past have performed across a variety of metrics. A decade in, the overarching goal of the awards remains the same: to help simplify the complex and time-consuming process of choosing and qualifying a contract manufacturer.