Expert Insights On Fill/Finish

81. 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.

82. 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?

83. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

84. B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing 8/9/2021

    After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.

85. Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product 8/6/2021

    It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.

86. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.

87. 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. 

88. A Better Approach To Aseptic Process Simulation For Lyophilized Products 5/9/2021

    Proposed 2020 revisions to EU Annex 11 with respect to aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on best practices for process simulation of the lyophilization unit operation. This article serves to address these expectations and present a risk-based, holistic best practice approach.

89. Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) 11/13/2019

    There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.

90. What Can We Learn From Compounding Pharmacies Producing Small Parenteral Batches? 11/11/2019

    Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?