When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.
- Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics
- What’s Process Intensification In Practice?
- System Impact Assessment: A Risk Management Framework For A COVID World
- Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
- 8 Biotech Startup Lessons From Heat Bio’s Jeff Wolf
- Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty
- Can Valneva Do What SmithKlineBeecham Couldn’t?
Can Valneva Do What SmithKlineBeecham Couldn’t?
As marketability goes—and despite a growing unmet medical need—Lyme disease vaccine programs have suffered a futile fate. With its VLA15 candidate, French specialty vaccine company Valneva is trying to change that. Recent positive Phase 2 data bodes well for the effort.
An at-home, self-administered, inhalable COVID-19 therapeutic is in the works. Given recent transmission spikes, troubling immunity data, and skepticism of a timely vaccine, it might be a critical tool in the effort to flatten the second curve.
Multiple of this company’s clinical-stage CAR T-Cell therapy candidates for solid tumor and blood cancers took cues from a discovery made by a renowned biologist trying to grow a genetically-engineered super fish.
Gone—for a while, anyway—are the days of pressing the flesh, pounding the pavement, and cross-crossing the conference scene with your pitch deck. Here’s how one successful startup biotech is maintaining its conduit to cash, despite travel restrictions and social distancing.
Fountain Therapeutics’ unique AI discovery platform prompted an invitation from Eli Lilly & Company to move Fountain headquarters to Lilly Gateway Labs. Here's how company CEO John Dimos, Ph.D. is squeezing the value out of the move, despite its execution during the height of the COVID-19 pandemic.
System Impact Assessment: A Risk Management Framework For A COVID World
Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.
Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.
Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty
Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.
Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions
In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.
Human Performance In Biopharma Operations — Your Problem Isn’t Error
This is Part 1 of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. In this part, we discuss key drivers for human performance improvement, compare lean manufacturing and human performance programs, and provide perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines.
Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products
This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"
Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity
Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants.
Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA
In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.
BIOPROCESSING WHITE PAPERS
Strengthen Your Chromatography Resin Supply Chain
This white paper explores key components of a chromatography resin supply chain program to help customers control their supply chains and ensure steady progress towards milestones.
Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes
Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.
Process Characterization: Ready For The FDA?
Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.
Golden Retriever Study: 5 Years Of Progress In Vet Health And Biobanking
An overview of a prospective cohort study of some 3,000 young Golden Retrievers, and how extensive data and biological samples will be used for future analyses of major diseases, disorders, or conditions..
Navigate The CMC Regulatory Landscape For Cell And Gene Therapies
The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.
Reducing The Risk During Cell And Gene Therapy Development And Manufacturing
While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.
BIOPROCESS ONLINE CONTENT COLLECTIONS
The world of aseptic systems has evolved faster in the last 5-10 years than it has over the history of the industry. This collection of articles from BioProcess Online covers the major aspects of our engineering concepts, successes and failures. The success and failures are equally important as lessons in our evolution and journey in achievement in this business. We hope you enjoy!More Content Collections
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Physician Compensation Update: What Providers Need to Know
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HIPAA HITECH Changes 2021 - What's New?
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Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
December 3, 2020
PowerPoint on the Fast Track: Presentations in Minutes not Hours
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Cutting Edge Issues in Virtual Care: Contracting and Compensating Physicians for Telehealth Services
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