Industry Insights
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When Considering Adipose Mesenchymal Stromal/Stem Cells
8/31/2022
Regardless of your favorite nomenclature for adipose tissue-derived hMSCs (hAD-MSCs, MSC(AT),AT-MSCs), there really is more beneath their story than meets the eye.
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The Importance Of Analytical R&D To Sterile Fill/Finish
Parenteral drug product development and production rely on the careful integration of supporting elements, with analytical support as key. Analytical support is required at all stages of the product’s life cycle, from early development to commercialization.
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Building Effective Multi-Year Process Development Programs I: Estimating hMSC Lot Size Ranges
1/13/2022
In this blog we outline a development program that could tailor accordingly to meet your final product platform needs, with target cell lot size foremost in mind.
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Pulling Double Duty: Packaging Considerations For Combination Products
1/2/2020
Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.
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Individual Or Pooled cGMP Audits — How To Choose The Right Format
7/3/2018
On-site cGMP audits are an important part of creating and maintaining a compliant, reliable, and secure supply chain that safely provides high-quality clinical and commercial drug products when and where needed. An important auditing decision is whether to use an individual or pooled audit.
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The Patient-Centric Clinical Supply Chain For Cell And Gene Therapies
8/1/2022
This article explores how delivering cell and gene therapies to patients requires new levels of agility, flexibility and innovation in the logistical management of supply.
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The Dating Game – Trust & Compatibility In Outsourcing Partnerships
5/12/2020
By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.
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Computerized Systems Validation And Audit Trail Requirements
10/18/2021
A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.
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Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences
9/3/2020
Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.
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How To Establish Growth Promotion Tests For Pharmaceutical Culture Media
1/7/2019
The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.