Critical Environments Featured Articles
-
Cleanroom Fungal Contamination Control Strategies
9/28/2021
A fungal contamination outbreak can result in everything from product recalls, with the associated reputational brand damage, and production downtime through to actual harm to patients’ health.
-
Modularity Is Key To Flexibility, Scalability In Drug Delivery Device Assembly
9/20/2021
How can machine vendors meet customer requirements and streamline drug delivery device assembly from the prototyping phase up to commercialization? The answer is modularity.
-
Increasing mRNA Capabilities And Capacity
9/20/2021
The growing mRNA vaccine market ― projected to reach $127.3 billion by 2027 ― is fueling high demand for mRNA, which has resulted in a critical need to address mRNA manufacturing bottlenecks.
-
How To Find & Manage Biotech Consultants Effectively
9/6/2021
The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.
-
What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
9/3/2021
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
-
Choosing The Right CDMO For HPAPI Development, Manufacturing & Packaging
9/2/2021
Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.
-
10 Critical Validation Parameters For Microbiological Experiments
7/26/2021
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.
-
PIC/S Annex Update: What Is Your ATMP Control Strategy?
6/30/2021
Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.
-
Transforming Your Biopharma Automation Capabilities
6/24/2021
Single-use technology equipped with a scalable distributed control system allows for collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of business.
-
Best Practices For Designing Microbiology Experiments
6/23/2021
A sound scientific approach can be taken for running experiments and qualification of microbiological methods. This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection, specificity, and quantification.