FEATURE ARTICLES
As much as controlling the process is desirable in selecting a CDMO, the marketplace is constantly changing, adding an element of unpredictability. When this happens, work hard to control the things that can be controlled, but be prepared to adapt to events that are out of your control by revisiting your search criteria and priorities.
- Making FMEA More Robust With HACCP
- Repurposing An Aging Facility To Produce Cell & Gene Therapies: Layout & Design Considerations
- Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”
- Trends In Bioprocessing CDMO Selection
- The Global Regulatory And Quality Environment For Biopharma Outsourcing
- A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future
- CBER Takes On More Oversight Of Biologic & Biosimilar Master Files
GUEST COLUMNISTS
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Making FMEA More Robust With HACCP
Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.
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Repurposing An Aging Facility To Produce Cell & Gene Therapies: Layout & Design Considerations
Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.
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Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”
How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”
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Trends In Bioprocessing CDMO Selection
Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.
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The Global Regulatory And Quality Environment For Biopharma Outsourcing
It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.
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A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future
This article describes how process validation concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.
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CBER Takes On More Oversight Of Biologic & Biosimilar Master Files
This year saw a significant change in the process for submitting drug master files (DMFs) for biologic products: as of March 23, biologic-related DMFs are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER). This transition of responsibilities presents a number of challenges for sponsors accustomed to working under the Center for Drug Evaluation and Research ( CDER).
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Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products
The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.
PHARMA ONLINE WHITE PAPERS
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Identifying Enhanced Needle Solutions & Integrated System Solutions To Serve The Chronic Disease Market
In addition to wider uptake of home care, an increase in the number of biologics being manufactured, many by the same company, is driving ongoing innovation in drug delivery systems. Identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
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Towards A Better Process Outcome
In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.
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Steps Ahead: Planning For Future Equipment Surpluses From The Point Of Procurement
Planning and preparation are the keys to success in any enterprise, and making plans for the possibility of equipment liquidation from the time of procurement is no exception. There are clear advantages to planning for your facility’s future, especially if it includes the opportunity for cost savings or a new way to look at purchasing budgets.
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What Clinical Teams Should Know About The Benefits Of Auto-Injectors
For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
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CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy
Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.
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An Introduction to High Containment For Lyophilization Processes
Almost every pharmaceutical and biopharma lab in the world are using lyophilization in their daily processes. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredients, protein, collagen, peptide, oligonucleotides, chemical API, enzymes, and mAbs. This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Seven Trends Impacting Chemical Process Development
- Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage
- How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, And Risk
- 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine
- Liquid Retention Comparison In PC And PETG Containers
NEWSLETTER ARCHIVE
- 09.08.20 -- Discovering And Motivating Talent In Pharma: Redefining "Other Duties And Responsibilities"
- 09.05.20 -- Solid Dose Manufacturing Product Showcase
- 09.04.20 -- New Podcast Episodes: Bolt Biotherapeutics On Fundraising; RNAi Beyond The Liver; Myeloid Cells In Immuno-Oncology
- 09.03.20 -- The Global Regulatory And Quality Environment For Biopharma Outsourcing
- 09.02.20 -- Can Tablet Shape Impact Patient Acceptance?
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Whether you’re trying to coax a toddler into taking cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.
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PHARMA INDUSTRY EVENTS
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International Conference on Analytical and Bio analytical Techniques
September 8 - 9, 2020
Roissy-en-France -
2nd Edition of Cardiology World Conference
September 8 - 9, 2020
Paris -
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requireme
September 8, 2020
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International webinar on Cardiology
September 8 - 9, 2020
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CPhI North America
September 9 - 11, 2020
TRAINING COURSES
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It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
September 17 - 17, 2020
Online Training; 1:00 - 2:00 PM EDT US -
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
September 22 - 22, 2020
1pm-2:30pm EDT, Online Training -
Adverse Event Reporting: Avoiding Common Pitfalls
September 24, 2020
1pm-2:30pm EDT, Online Training -
Stability Programs – Key Factors in Meeting FDA/ICH Expectations
October 8 - 8, 2020
1pm-2:30pm EDT, Online Training -
21 CFR Part 11: Understanding the ERES Regulation for Compliance Success
October 13 - 13, 2020
1pm-2:30pm EDT, Online Training