The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components for a holistic sterility assurance program needed for an aseptic manufactured product.
- Slippery Slope: Competitive Differentiation In Biopharma
- An Introduction To Biopharma Facility Design & Layout
- COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
- Inside Aruvant’s Gene Therapy Manufacturing Strategy
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
- Is A SPAC The Right Option For Your Emerging Biotech?
Big Bio: Inside SILS’ New Stake In Biocon
The sum of government vaccine mandates and a pandemic that’s turning endemic make simple math out of a $5 billion big bio deal.
Agency filings require accuracy, dialog, order, and precision. We caught up with two biopharma regulatory experts who have seen breakthrough therapy designation success to get their firsthand advice on how to get it done.
Araris Biotech AG CEO and co-founder Dr. Philipp Spycher says his company’s linker technology eliminates the antibody engineering requirement, is more stable and efficacious, and requires far less drug payload than those currently in use. Now it’s building a pipeline and seeking partnerships.
How Kyowa Kirin North America is strategically leveraging an incredible growth spurt to fuel its diversity & inclusion initiatives, attracting and retaining biotech talent that’s as diverse as its therapeutic portfolio.
Revolo Biotherapeutics is reaching for its share of the massive autoimmune disorder and allergy markets with novel protein-based therapies designed to reset the immune system. CEO Jonathan Rigby sat down with us on the heels of an IND approval for Revolo’s fourth Phase 2 clinical trial.
An Introduction To Biopharma Facility Design & Layout
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
Is A SPAC The Right Option For Your Emerging Biotech?
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
Forging A New Path Forward in Manufacturing Genetic Medicines
While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.
Is The FDA About To Reclassify Your Drug Product As A Device?
Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
BIOPROCESSING WHITE PAPERS
Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography
The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.
Accelerating Cell Line And Process Development8/27/2020
This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.
From Research To Commercial: A Seamless Supply Of Oligonucleotides4/24/2020
This white paper discusses how to meet the seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.
Can You Afford Not To Outsource Buffer Preparation?2/6/2020
The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.
How Integrated Market Intelligence Improves Aseptic Fill/Finish Outcomes10/13/2020
To offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering.
Stirred-Tank Bioreactors For COVID-19 Vaccine Development And Production7/6/2020
Bottlenecks arise from the use of two dimensional T-flasks and roller bottles. Stirred-tank biological control systems are essential to increased productivity in the development of COVID-19 vaccines.
BIOPROCESS ONLINE CONTENT COLLECTIONS
With the combination of market potential, rapidly improving manufacturing technology, and intense competition comes the necessity for biopharma companies to ensure the patent protection of their molecules early, and to plan strategically for protection beyond commercialization. To provide context and direction, we've procured this collection of fresh thought leadership columns from biopharmaceutical patent experts.More Content Collections
FEATURED PRODUCTS AND SERVICES
SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.