A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.
- Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: Sizing Up The First Wave
- Next Steps For AI, Machine Learning In Biopharma
- A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs
- Inside Wugen’s Off-The-Shelf CAR T Mission
- Advancing The State Of Aseptic Processing: Let’s Get Serious
- Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics
- What’s Process Intensification In Practice?
What’s Process Intensification In Practice?
I understand why “process intensification” is a buzzword embraced by the vendor and consulting communities. Now I want to know what the term means to biopharma companies, and whether—and how—you’re implementing it.
With apologies to Tom Petty, as biotechs go it’s the starting that’s the hardest part. No one knows this more than Jeff Wolf, who’s responsible for more than a few biotech startups. We caught up with Wolf for a candid talk on the toughest aspects of birthing a biopharma.
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.
A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs
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.
Advancing The State Of Aseptic Processing: Let’s Get Serious
It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics
All partners in the vaccine supply chain recognize that the supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and corrective and preventive actions of supply chain issues and technical support for analytical challenges need to be addressed.
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.
BIOPROCESSING WHITE PAPERS
Manufacturing: CDMOs, Blockchain, And Distributed Ledger Technology
CDMOs and pharma developers can improve supply chain transparency with distributed ledger technology. Learn the integration, cost, governance, and accountability challenges DLT presents here.
An Introduction To High Containment For Lyophilization Processes
This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.
Critical Factors Of Fill Finish Manufacturing For Large Molecules
Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.
More Efficient Bispecific Antibody Purification With Fewer Steps
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Three Options To Viral Vector Manufacturing Capacity
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.
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.
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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LIFE SCIENCE INDUSTRY EVENTS
Digital Marketing for Healthcare - Connecting Audience to Industry Online
December 8, 2020
Physician Employment Agreements: Items to Consider
December 14, 2020
The Healthcare Quality Improvement Act: The Quest for Immunity in Your Peer Review Process
December 15, 2020
Designing Compliant Physician Compensation Models With Stark Law Reform on the Horizon
December 16, 2020
Structuring and Auditing Physician Medical Director and Administrative Arrangements: Key Stark Law Considerations
December 17, 2020