Newsletter | August 2, 2024

08.02.24 -- A Holistic Approach To Container Closure Integrity

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AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

FOCUS ON FILL-FINISH

A Holistic Approach To Container Closure Integrity

Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

How Recent Trends Impact Bringing Your Molecule To Market

With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

Fluid Connection Technologies For Sterile Fill/Finish Process Design

Single-use technology and innovative fluid connections play a significant role in creating an effective, sterile fill/ finish operation that maintains the integrity of your biologic products.

Tips For Designing A Single-Use Manifold For Advanced Therapies

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

How To Reduce Five Key Risks In Fill/Finish

Explore how automation and best-practice solutions can help cell therapy manufacturers de-risk their fill/finish process.

FILL-FINISH SOLUTIONS

PharmaLok Clamps - Nordson MEDICAL

Flexible Filling Capabilities For Rigorous Demands - Argonaut Manufacturing Services

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Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific.

FOCUS ON SUPPLY CHAIN

Single-Use Supply And Sourcing: Eliminating Risk

Explore single-use technologies supply chain and reflect on what we’ve learned about supply chain security since COVID and mitigating the regulatory risks associated with multi-vendor qualification.

Advancements In Small Volumes Drug Freezing Techniques

Explore the benefits of different freezing techniques for small batches and their ability to meet the specific requirements and characteristics of different drug substances.

Single-Use Technologies: Trends And Top Tips For Making The Switch

Single-use technologies are an integral and rapidly growing part of the bioprocessing manufacturing landscape. Take a look at trends in single-use, plus top tips for making the switch.

How To Measure Particulate Contamination Levels In Single-Use Systems

Compare single-use system bags, focusing on their design, materials, and applications to better understand why controlling particulate levels is critical to maintaining product purity and efficacy.

SUPPLY CHAIN SOLUTIONS

Single-Use Flexible Freeze Containers For Bulk Drug Substance - W.L. Gore & Associates

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