Industry Insights
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Unlocking Potential: Exploring Treg Cell Therapy
Treg cell therapy holds immense promise for millions of patients grappling with debilitating diseases. Review strategies for manipulating Treg activity to unleash the full potential of immunotherapy.
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Driving Continuous Improvement With A Fully Integrated Quality System
A well-designed quality system has a global scope, incorporating guidelines from all relevant markets and assuring data quality and integrity through adherence to quality standards, policies, and procedures.
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Accelerate The Start Of Your Outsourced Pharmaceutical Project
In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).
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Supporting The Rapid Launch Of Pharmaceutical And Biopharma Products: A Contract Packaging Perspective
9/15/2020
Product launches see pharma and biotech companies handing over drugs with incredible value, both commercially and to the health of patients globally, to contract packaging partners. Many of the virtual and small biotech companies simply lack the infrastructure necessary to handle packaging and large pharma companies tend to outsource as contract service providers offer experience and significant surge capacity for short or extended periods of time.
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5 Characteristics Of The Automated Microbiology Lab Of The Future
4/24/2023
The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.
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Is The FDA About To Reclassify Your Drug Product As A Device?
9/27/2021
Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
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Taking Control Of Quality Tolerance Limits In Clinical Trials
1/8/2019
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs have historically been required for good manufacturing practice (GMP) activities, inferring limits at which significant actions must be taken to ensure the manufactured product achieves quality and usability limits.
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FDA’s Digital Health Technologies Framework Addresses Important Challenges
5/16/2023
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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How Well Are Your HCP ELISAs Covered?
3/27/2019
Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.
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Nickels & Dimes: What To Do When Your CDMO Charges You Unexpected Fees
12/17/2019
In many cases, the business development and sales teams from your organization and the contract service provider work separately. What happens when the invoices have unexpected costs?