To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of active pharmaceutical ingredients (APIs) and associated intermediates. This presents a risk of cross-contamination that might not be detected when the solvent is tested before offloading into a manufacturing site distribution system. This article explores the risks and 11 mitigation options available to API manufacturers.
- Taking On The Talent Crunch In Biopharma, Cell & Gene Manufacturing
- The “New Normal”: Changing Perceptions on Bioprocess Intensification and Continuous Bioprocessing
- Keeping Clinicals On-Pace In The COVID-19 Age
- Important cGMP Considerations For Implementing Electronic Batch Records
- Incorporating Excipients Into QbD Studies For Drug Development — An Introduction
- Dr. Bobby Gaspar On Manufacturing, Commercialization Challenges
- FDA Steps Up Support For Advanced Manufacturing Technologies
Dr. Bobby Gaspar On Manufacturing, Commercialization Challenges
Orchard Therapeutics CEO Dr. Bobby Gaspar, M.D., Ph.D. is one of only a handful of gene therapy leaders to see the light of market-approved therapy. Here, he offers advice for those seeing manufacturing, regulatory, and reimbursement challenges for the first time.
With its ongoing Phase 1 clinical trial of ACE1702 for the treatment of HER2-expressing solid tumors, Acepodia founder, CEO, and president, Sonny Hsiao, Ph.D. and SVP of R&D, Mark Gilbert, M.D., make a case for fast, affordable, and effective off-the-shelf cell therapies.
In many gene therapy applications, an immune response barrier stands in the way of leveraging adeno-associated virus vectors. Here’s how Dr. Carsten Brunn’s clinical-stage firm Selecta Biosciences is addressing the challenge with its nanoparticle technology-based platform.
As scientific and investment interests in vaccine development advances crescendo on the back of COVID-19, Cincinnati-based biotech startup Blue Water Vaccines seeks to revolutionize the approach to influenza vaccinations. We caught up with CEO Joseph Hernandez for the story.
Urgent medical needs like COVID-19 therapeutics are fueling new interest in cell-based therapies, despite a years-long, uphill social battle. Here’s how one company’s persistent, global pursuit of safely harvested biologics is positioning it to address the greatest medical need of our time.
Important cGMP Considerations For Implementing Electronic Batch Records
Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
Incorporating Excipients Into QbD Studies For Drug Development — An Introduction
This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!
FDA Steps Up Support For Advanced Manufacturing Technologies
In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.
FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.
Developing Future Delivery Models For ATMPs: Practical Considerations
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.
7 Rules For Properly Interpreting Control Charts
It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
BIOPROCESSING WHITE PAPERS
Got Data? Using Informatics To Protect And Improve Your Business
Life science companies are realizing benefits from informatics in manufacturing. Are you ready to use data and analytics to improve decision making? There are things you can do now to get started.
8 Key Factors When Selecting A Powered Air-Purifying Respirator System
This white paper explores eight considerations in detail and could be helpful to EHS managers and supervisors looking to select a Powered Air-Purifying Respirator system for their particular application.
Beyond COVID-19: How Localization Strengthens Supply Chains
The coronavirus pandemic has already changed the way industry looks at localization and forming resilient supply chain capabilities. In the current climate, not having local capabilities could shutter your business.
Making The Medicine Go Down: Specialized Delivery Technologies
In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.
Can mRNA Disrupt The Biopharma Industry?
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel: A Guide For Adoption
The development of the Blazar™ Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
BIOPROCESS ONLINE CONTENT COLLECTIONS
As the initiative to combat the global pandemic continues to play out and consume supply chain resources, the fast-approaching requirements of the Drug Supply Chain Security Act (DSCSA) remain. To help biopharma supply chain pros juggle these equally high priorities, we've assembled a collection of columns on these supply chain considerations, authored by independent experts on the topics at hand. We trust you'll find their guidance valuable.More Content Collections