Selecting the right CDMO for your project is essential. Here is a practical 7-step process, along with key considerations and pitfalls to avoid along the way.
- Maintaining Harmony With Your CDMO Using 'The Middle Way'
- A Comprehensive Guide For Supplier Quality Agreements
- Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
- Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
- Safety Cabinets' Essential Role In EU GMP Annex 1
- Life Sciences Cybersecurity Incident Management: The End-to-End Approach
- Exploring Sanofi R&D's Batch Monitoring Initiative
GUEST COLUMNISTS
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Maintaining Harmony With Your CDMO Using 'The Middle Way'
Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.
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A Comprehensive Guide For Supplier Quality Agreements
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
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Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
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Safety Cabinets' Essential Role In EU GMP Annex 1
A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.
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Life Sciences Cybersecurity Incident Management: The End-to-End Approach
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
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Exploring Sanofi R&D's Batch Monitoring Initiative
The project established predictability during testing and release for the production of medicine to support clinical trials.
BIOSIMILAR WHITE PAPERS
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Quantitation Of Monoclonal Antibodies In Serum
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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Performance Characteristics Of The MobiusĀ® ADC Reactor For Conjugation10/22/2024
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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Establishing Commercial Manufacturing Services For ADCs6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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The Role Of Extractables Data In The Adoption Of Single-Use Systems8/29/2024
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
BIOSIMILAR APP NOTES & CASE STUDIES
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- MilliporeSigma Invests $76 Million To Expand ADC Manufacturing For Novel Cancer Therapies
- European Medicines Agency Confirms Acceptance Of Marketing Authorization Application For AvT05, A Proposed Biosimilar To Simponi® (golimumab)
- Meitheal Pharmaceuticals Secures Exclusive Commercial Licensing Agreement For Three Biosimilars In The U.S.
- US FDA Accepts Biologics License Application (BLA) For HLX14, Biosimilar Candidate Of PROLIA/XGEVA (denosumab)
- CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code And Pass-Through Payment Status For Tyenne (tocilizumab-aazg)
- AscellaHealth Releases Q3 2024 Specialty & Rare Pipeline Digest™: FDA-Approved Biosimilars Outpaces Cell And Gene Therapy Amid Complex Regulatory Challenges
- Alvotech And Teva Announce U.S. FDA Approval Of Additional Presentation Of SELARSDI™ (ustekinumab-aekn), Expanding Its Label To Include Further Indications Approved For Reference Product, Stelara® (ustekinumab)
- CHMP Recommends The Approval Of Dong-A ST's IMULDOSA, A Biosimilar To Stelara