Newsletter | November 7, 2024

11.07.24 -- Peptide Synthesis: New Market Research

SPONSOR

Webinar: Implementing PIC/S Annex 1: Contamination Control Strategy with QRM Principles

Be sure to attend on November 19th as we cover the fundamental principles of contamination control, including the identification and management of contamination hazards, risk mitigation strategies, and the alignment of these strategies with QRM methodologies. Participants will gain a clear understanding of how to organize and document contamination control measures across various processes, while ensuring regulatory alignment and minimizing the risk of non-compliance.

INDUSTRY INSIGHTS

Continuous Manufacturing: An Evolving Technology For Drug Substance Manufacturing

Discover the exciting developments in continuous manufacturing, and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

How To Prove A Sterility Assurance Level Of 10⁻⁶

Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process.

Constraints And Solutions For Biopharmaceutical Manufacturing

Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.

How A Top 5 Pharma Realized $20M In Annual Savings

A top 5 pharma company faced a threat to their flagship product and aimed to enhance profitability despite a high COGS. Learn about the solution that played a key role in overcoming this hurdle.

Elevating Quality Beyond Compliance

See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce.

Which Microscope Camera Is Right for You?

What are the key factors to consider when choosing the right microscope camera for your system and experimental needs?

The Impact Of Early Process Design On Your Supply Chain

Explore tips to optimize your network supply chain by using a minimal number of unique manifolds to address diverse unit operations requirements.

How Compounding Pharmacies Are Combating FDA Drug Shortages

Gain insight into the global impact of pharmacy compounding, which is critical in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

Smart Softgels: Driving Innovation In Pharma

Learn about how softgels are poised to facilitate innovation in the pharmaceutical industry as well as ongoing advancements in optimizing drug bioavailability through nano formulations.

How To Ensure A Successful Health Authority Inspection

Discover how to proactively prepare for successful Health Authority Inspections. Learn key strategies and post-inspection activities for regulatory compliance.

DataOps For Manufacturing: A 4-Stage Maturity Model

Examine a maturity model that was created to help you better understand where you are on your DataOps journey and where you need to go to achieve the results you expect.

Using Synthesis And Route Design Technology To Approach API Complexity

Leveraging computer-aided synthesis design technology and route scouting in the early stages of development can aid you in designing an efficient and cost-effective path to API manufacturing.

Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing

Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

Designing Shelf-Stable, Dry Powder Vaccines To Improve Global Access

Spray dry technology is being leveraged to create shelf-stable, dry-powder vaccines to treat and prevent the spread of tuberculosis which could significantly improve our global response to disease.

Does Your CDMO Have Sustainable API And RSM Strategies?

How can you be sure the CDMO you select has appropriate oversight and management of their RSM and API manufacturing supply chain, so you do not experience costly delays?

A Robust Extractables Data Package Helps Drive Patient Safety

Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

FEATURED EDITORIAL

Peptide Synthesis: New Market Research

Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.

SOLUTIONS

Formulation And Manufacturing Equipment

Partner With The Experts In Annex 1

System Monitoring Software To Maximize Lab Productivity

Cleaning And Disinfecting For Viruses And Other Pathogens

Primary Drug Containers

Advanced Automation System For Flexible Aseptic Filling

High Potency Manufacturing

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