About BioQC
BioQC is a global knowledge platform for scientists, researchers and innovators involved in the development and manufacturing of biopharmaceuticals and biologicals.
We deliver in-depth, expert-driven content and facilitate meaningful discussions around the challenges and innovations in CMC and related areas. From FIH studies to market approval, we support every stage of drug development with expert insights delivered via articles, eBooks, webinars, expert forums, and a thriving user community.
At BioQC, we believe that knowledge sharing accelerates progress — leading to more robust processes, faster development timelines, and safer, high-quality medicines for patients worldwide.
BioQC Topics
We bring together specialists from all key disciplines involved in the lifecycle of biologics, covering CMC Management, including: Analytical Development & Quality Control (QC), Process & Product Development, Quality Assurance (QA) & Regulatory Affairs, Manufacturing, Laboratory Informatics & Data Integrity, and Guidelines & Compliance.
Dr. Christof Finkler
F. Hoffmann-La Roche AG
Dr. Pierre Lebrun
Cencora – PharmaLex
Anne Ries, PhD
Boehringer Ingelheim
Dr. Eric Rozet
GSK
Dr. Cyrille Chéry
UCB
Prof. Sandra Furlanetto
University of Florence
Dr. Patanachai “Kong” Limpikirati
Chulalongkorn University
Dr. Lars Geurink
Batavia Biosciences
Dr. Simona Cianetti
GSK
Dr. Joachim Ermer
Ermer Quality Consulting
Dr. Bingchuan Wei, MBA
Genentech
Francisca Galindo Garre, PhD
Johnson & Johnson Innovative Medicine
Jon Walker
LabWare North America
Ejvind Mørtz, PhD
Alphalyse
Dr. Adam Sutton
Merck
Dr. Lu Huixin (Lulu)
Health Canada
Melanie Clark
LabWare North America
Dr. Jennifer Rea
Genentech
Dr. Timothy Blanc
Eli Lilly and Company (retired)
Ramon de Groot
Limes Lab Support
Paul Schrevel
Solution Too
Carmilia Jiménez Ramírez, PhD
Miliar Biopharma Solutions
Dr. Joseph Glajch
JLG AP Consulting
Dr. Michael Dong
MWD Consulting
Gloria Slomczynski, MBA
Laboratory Informatics and Management Consultant
CMC (Chemistry, Manufacturing, and Controls)
- Quality Target Product Profile (QTPP)
- Product specifications
- Patient-centric Pharmaceutical Development
- Personalized Medicine
- Outsourcing
- Biosimilars
- Stability
- Reference standard management
- CMC knowledge management
- Product control strategy
- Critical Quality Attributes (CQAs)
- First in human (FIH)
Analytical Development & Quality Control (QC)
Analytical Development
- Method development
- Method transfer
- Method qualification and validation
- Total error concept
- Method implementation
- Updating Analytical Procedures
- Method Life-Cycle Management (MLCM)
- Lab automation
- ICH Q2(R2) – Validation of Analytical Procedures
- ICH Q14 – Analytical Procedure Development
- Analytical Quality by Design (AQbD)
- Cleaning verification
- Analytical Procedure Control Strategy
- PAT (Process Analytical Technology)
Quality Control (QC)
- Method implementation
- Batch testing and release
- Stability testing
- Safety testing
- Microbiological testing
- In-process control testing
- Compendial method compliance and testing
- Characterisation support
- Environmental monitoring
- Method qualification, validation and verification
- Method lifecycle management
- Reference Material Management
- Traceability and data integrity
- Equipment: IQ, OQ, PQ
- Equipment: Maintenance
- Equipment: Updating equipment
- Equipment: Calibration
- Laboratory efficiency (5S)
- Training and competency management
- Out-of-specification (OOS) and out-of-trend (OOT) handling
Process & Product Development
Process Development
- Protein purification
- Preparative chromatography
- Downstream processing
- Upstream processing
- Scale up
- Process characterisation
- Process Validation
- Process monitoring and controls
- Biosimilars
- PAT (Process Analytical Technology)
- Quality by Design (QbD)
- API / Drug Substance (DS) development
- Drug Product (DP) development
- Starting material characterisation
- Critical process parameters
Downstream Processing (DSP)
- Protein purification
- Preparative chromatography
- Filtration
- Viral clearance
- Purification
- Process impurities characterisation
Upstream Processing (USP)
- Bioreactors
- Cell culture media
- Expression platforms
- Cell culture and fermentation
- Cell-line selection
Formulation Development
- Excipients
- Formulation screening
- Extractables and leachables
Quality Assurance (QA) & Regulatory Affairs
- Dossier writing
- Regulatory strategies
- Change control/comparability
- Deviations and CAPA’s
- Audits and inspections
- IND/IMPD
- Post-approval changes
Manufacturing
- Scale up
- Supply chain
- Facility design and engineering
- Raw material release
- Cleaning verification
- Packaging, labelling and distribution
Laboratory Informatics & Data Integrity
- LIMS – Laboratory Information Management Systems
- ELN – Electronic Laboratory Notebooks
- LES – Laboratory Execution Systems
- SDMS – Scientific Data Management Systems
- CDS – Chromatography Data Systems
- Data integrity – ALCOA, ALCOA+
- Audit trails and user management
- System validation – CSV, CSA
- Part 11 and Annex 11 compliance
- Master data management
- Data lifecycle management
- Electronic records and electronic signatures
- Interface management – instrument and ERP integration
- Cloud validation and SaaS compliance
Guidelines & Compliance
- GMP – Good Manufacturing Practice
- GLP – Good Laboratory Practice
- GCP – Good Clinical Practice
- GDP – Good Documentation Practice
- ICH – International Council for Harmonisation
- USP – United States Pharmacopeia
- EP – European Pharmacopoeia
- JP – Japanese Pharmacopoeia
- EMA – European Medicines Agency
- FDA – Food and Drug Administration
- EudraLex – EU pharmaceutical legislation
- WHO guidelines
- ISO standards
BioQC Solutions
Through expert forums, webinars, published articles, executive summaries, video articles, a user community, and the Insights eNewsletter, BioQC ensures that cutting-edge insights are easily accessible online to the global scientific community.
This is especially beneficial for scientists, researchers, or industry innovators who cannot attend in-person conferences and events.
BioQC Team
Prof. Dr. Cari Sänger-van de Griend
Scientific Director
Prof. Dr. Cari Sänger–van de Griend is a founder and scientific consultant at Kantisto and an associate professor at Uppsala Universitet in Sweden. Cari holds an MSc in BioPharmaceutical Sciences from Universiteit Leiden and a PhD and Habilitation in Analytical Pharmaceutical Chemistry from Uppsala Universitet. She has previously worked with Astra Pain Control, AstraZeneca, Solvay Pharmaceuticals, and Abbott Healthcare Products, focusing on small molecules, therapeutic proteins, vaccines, and nucleotides. In her daily role, Cari supports industry, institutes, and academia in the realm of (bio)pharmaceutical analytical chemistry and Analytical Quality by Design (AQbD). She is dedicated to sharing knowledge and fostering scientifically sound decisions with the patient in mind.
Dr. Ewoud van Tricht
Scientific Director
Dr. Ewoud van Tricht has over 18 years of experience in the (bio)pharmaceutical industry. He has worked on small molecules, antibodies, proteins, viruses, and cell therapies at companies such as Abbott Healthcare Products, Janssen Vaccines, and Sanofi Cell Therapy. Alongside his full-time career, he completed a Bachelor’s, Master’s, and PhD in Analytical Chemistry. Ewoud specialises in Analytical Quality by Design (AQbD), having developed and implemented strategies to enhance pharmaceutical methods. He is passionate about optimising processes, coaching teams, and driving innovation through AQbD, Agile, and Lean methodologies, always striving for efficient and impactful results.
Dean Graimes
Managing Director
Dean’s career has been entirely focused on media and publishing. His experience encompasses aviation, economics, medical, and scientific fields. He has worked for Reed Elsevier, Thomson Financial, Advanstar, and, most recently, Separation Science, which he co-founded. Dean has developed over 300 online events and forums in pharmaceutical methods and analysis, environmental science, food science, and clinical science, attracting 60,000+ scientists. He is passionate about creating essential content, bringing communities together, and aligning vendors with their end customers.
Jeroen Reiniers
Commercial Director
Jeroen Reiniers began his career in strategy and corporate development at Arthur Andersen & Co., McKinsey & Co., and Reed Elsevier, where he primarily focused on the media, information services, and workflow solutions sectors. Following this, he took on sales, marketing, and business development roles at LexisNexis, Elsevier (ScienceDirect and Voyager ILS), and Thomson Reuters Scientific (Web of Science, Thomson Pharma, and Derwent Innovation). Over the last 15 years, Jeroen’s knowledge and skills have driven the growth of Eclipse Business Media (including Separation Science, Chromatography Forum, and Analytical Training Solutions). His primary strengths encompass fostering customer success, driving sales growth, and reshaping marketing efforts.
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