Biosimilar Manufacturing solution center

1. Essential Elements Of Technology Transfer 9/19/2023

   The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.

2. Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development 9/14/2023

   The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

3. Continuous Processing For Enhanced Monoclonal Antibody Production 9/14/2023

   Explore highlights from a recent webinar where experts from Cytiva and Chugai Pharmaceutical, a Roche company, discussed their unique collaboration for the continuous processing of mAbs.

4. New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters 9/11/2023

   The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

5. Survey Results Show What Could Finally Make Sustainability Stick 9/8/2023

   Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.

6. Have You Adopted A Manufacturing Execution System Yet? 9/7/2023

   Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.

7. Effective Quality CDMO Contracting 9/6/2023

   Choosing the right CDMO is a complex and difficult task and, given the regulatory framework within which the industry operates, it is essential that companies seeking a CDMO get the right partner. Let's look at what you should include in RFPs and other key considerations.

8. RFID-Based Unit-Level Traceability: Could It Be The Key To Operational Excellence For Fill-Finish Lines? 9/5/2023

   Radio frequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

9. Biopharma Manufacturing For Advanced Therapies: A Panel Discussion 9/1/2023

   Explore highlights from a panel discussion focused on improving biomanufacturing processes to help ensure the next generation of advanced therapies is both accessible and affordable to patients.

10. Enhancing Security Of Supply Of Cell Culture Media With Single-Use Bags 9/1/2023

    Biopharma manufacturers continue to face a challenging supply and demand landscape. Learn how Cytiva secured its single-use bag supply with in-house manufacturing of liquid media bags.