Welcome to the Continuous Manufacturing Knowledge Center (CMKC) community! We're thrilled to have you as a member. The CMKC is a friendly online space for professionals to connect and discuss all things related to pharmaceutical continuous manufacturing. We want to provide an engaging, welcoming environment where CM professionals like you can learn, connect, and thrive.
Here are a few tips to help you get started:
Add your photo to help us recognize you and build trust among members.
Introduce yourself below.
Join a Group that aligns with your interests from our six topic Groups.
To ensure a great experience, we encourage you to abide by the golden rule: use the community how you would want others to use it. If you're unsure what to post, consider how you would feel if you came across the post yourself. Would you find it interesting, friendly, and welcoming? If you need assistance crafting a post, email us at cmkc@usp.org. We're here to help!
Once again, welcome to the CMKC community! We're excited to have you join us and look forward to your active participation.
My name is Nathaly Movilla Meza and I'm a doctoral student of Chemistry in the University of Puerto Rico, at Mayaguez. My advisor is Dr. Rodolfo Romañach and I've been working with him since 2019 in things related with Continuous manufacturing and Process Analytical Technology (PAT).
Hello everyone, my name is Julie and I work at USP Richmond AMT Lab-the newest analytical facility that USP just opened last Dec, and AMT lab is capable to provide PAT support of flow chemistry and continuous manufacturing to pharmaceutical industry partners, and I am very excited to join this CMKC community and looking forward to more engagement!
I am a professor of engineering at Clarkson University and a founder of a start-up company, Pharmacoustics Technologies, LLC.
My USP relevant interest is the applications of ultrasound and acoustics in CM, my focus is on the modernization of pharma manufacturing using advanced technologies, AI/ML, public blockchain technology as well as computer algebra and ultrasonics - of course-.
Below I include links to various aspects of my work, from research to teaching.
Çetin Çetinkaya, Professor and Jesanis Endowed Chair
| Director, Photo-Acoustics Research Laboratory |
| Dept. of Mechanical and Aerospace Engineering |
| W. H. Coulter School of Engineering |
| Clarkson University | 8 Clarkson Ave. CAMP 241 Box 5725 |
| Potsdam, NY 13699-5725, USA |
| | (315) 268-6514 |
| Spring 2023 Office Hours: Tuesday/Thursday 10:00-12:30 | By Appointment |
| Google Scholar Citations: |
scholar.google.com/citations?hl=en&user=Qcuq9QMAAAAJ&view_op=list_works&sortby=pubdate
Hello everyone, my name is Rajesh and working at syngene international Ltd as Corporate Quality assurance, the company will provide the customer Research oriented(CRO),The services will provide to drug Development to Commercial scale with world class infrastructure and I am very excited to join this CMKC community and looking forward to more engagement! Reframe
I am a senior manager of Product Quality and Analytical Method group at Digital & Innovation (D&I) of USP. I understand relatively well about the need of analytics in drug manufacturing and am interested in advancing technologies that provide quick and sufficient information for development and manufacturing control. I am looking forward to participating discussions in these areas.
My name is Vanesa Distaso, I am a Pharmacist and work in R&D, as a manager of pharmaceutical development.
We are not current using Continuous Manufacturing, but we are interesting in this technology. We are in a laboratory specialized in oral solid forms in Argentina.
I am looking foward to participate and learn a lot! Thanks, regards, Vanesa.
i am a professor for chemical engineering with specialization in particle and fluid flow simulations. I am interested in food and pharma processes, and "going continuous" is certainly also challenging from a "flow perspective".
If you want to see what I teach, it is best to join this (free and open) MOOC: https://imoox.at/course/dem
Hi I am Jithendra Baswa, I am Having 17 + years of experience in Pharmaceutical Microbiology, Sterility Assurance, Quality Management systems , Audit and compliance, QC laboratory compliance, Aseptic manufacturing Compliance in sterile Injectables ( Pharmaceutical injectables and vaccines)
My name is Hibre Terefe, Ph.D., Director of Research and Development, Clinical Development and Supply at Catalent Pharma Solution, a global CDMO at the Somerset, NJ site.
I am interested in Pharmaceutical Continuous Manufacturing and would like to expand my knowledge and expertise in this area. I believe this group is the right forum to exchange knowledge engage in discussions about PCM.
Looking forward for a vibrant discussion and knowledge exchange.
I'm Hirofumi Suzuki at Bayer Yakuhin Ltd. in Japan. I'm a member of Consortium of Continuous Pharmaceutical Manufacturing Japan (CCPMJ) and curious about Conitinuous Manufacturing.
My name is Hossein. I work at FDA. Below is the link to my LinkedIn profile and a brief bio. Looking forward to connecting and collaborating with you all.
Bio: Hossein has more than 10 years of experience at the FDA, private sector and in academia related to investigation and research of pharmaceutical manufacturing. In his current role as program manager in the Advanced Medical Products Manufacturing (AMPM) team in Office of Regulatory Affairs (ORA) within FDA, Hossein oversees developing and implementing projects related to advanced manufacturing. In his previous roles, He has been recognized as a leading expert in several areas of AM utilized in development of novel medical products such as ophthalmic implants, drug products containing nanomaterials (e.g., mRNA containing liposomes), polymeric implants and drug-device combinations. Specific examples of advanced manufacturing techniques that Hossein has experience in include but are not limited to end-to-end continuous manufacturing (CM) of drug substances and drug products, investigation of process analytical controls (PATs), 3D printing, continuous extrusion/blending/granulation/tableting and model-based controlled strategies (e.g., digital twin).
This is Affan Ali, I am a pharmaceutical regulator from Pakistan, I have 10 years of experience in different aspects of pharmaceuticals and biologicals from manufacturing of biologicals, quality control of pharmaceuticals, quality systems and GMP inspections. Currently I am working with WHO as a consultant to support Medicine Control Agency, The Gambia.
I am Saud Alhwaimel am a pharmaceutical technical and regulator from Saudi Arabia, I have mor than 20 years of experience in local authority and local pharmaceutical company in different aspects of pharmaceuticals and biologicals.
I am Sujey., I work in phamaceutical laboratory as a regulatory affairs specialist. I am interested in advancing technologies and documentation that provide fast and sufficient information for development and manufacturing control.
I am a scientist both by passion and profession having played a pro-active role in the academic institutions and research laboratories for over 10 years. Currently, I am striving to work in the filed of biopharmaceutics.
In terms of my academic background, I hold a PhD in Biochemistry from India and bring with me 5 years of postdoctoral research experience resulting into research papers of international repute. My PhD and postdoctoral research focused on screening, isolation, purification, extensive physico-chemical characterization, immobilization of thermostable enzymes like alpha-amylases and laccases and their exploitation for diverse industrial applications. In my most recent role, I served as a Scientist in a group focused on Novel Biologics and Biosimilars within the R&D industry in India. During this time, my responsibilities were extensive and multifaceted. My role required a high level of engagement in the analysis and interpretation of data related to protein/mAb characterization studies, and contributed in preparation of CMC documents for regulatory submission. Besides, preparation and review of other documents/reports like PDR, TTD, STP and SOP was also a part of my role.
Currently, I am also serving as an Academic Editor, Editorial Reviewer and also Section Editor (Special Issues) for several highly reputed research journals, thus adding my active contributions to the scientific community through participation in the scientific peer review process.
I have a keen interest in Continuous Manufacturing and am eager to enhance my understanding and skills in this field. I am confident that this group provides an ideal platform for sharing knowledge and participating in discussions related to PCM.
I bring over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable execution.
Currently at SomaLogic (now Standard BioTools), I am a Director of Program Management and lead the program management team responsible for high-profile complex life sciences programs and product commercialization.
At Invitae, I built the program management team focused on change management and integration of product and program development activities following the acquisition of an oncology diagnostics product portfolio.
As a founder and principal consultant at Forward Aspect, LLC I am passionate about providing strategic leadership on best practices of planning, business operations and execution for various organizations.
During my 5-year tenure at BioMeriux, formerly BioFire Diagnostics, I directed infectious disease IVD project pipeline across multiple departments.
Previously, I spent 6 years leading and performing due diligence assessment for a portfolio of early-stage ideas, technologies, licenses, start-up companies in the areas of life sciences, medical devices, software and engineering at the Technology & Venture Commercialization Office, University of Utah.
I'm pleased to connect and partner with all of you in progressing very important topics in our industry. My career spans 29 years in global pharma/biotech includes Process Development, Manufacturing, Facility Start Ups, Regulatory, and Quality for large and small, clinical to commercial stage organizations, across multiple modalities and dosage forms.
I'm currently the SVP of Quality and CMC Regulatory at ReCode Therapeutics, enabling the development of mRNA lipidnanoparticles for rare diseases, and CEO of Clarity Global, LLC Consulting, delivering efficient strategies to organizations transitioning from clinical to commercial operations.
I look forward to engaging with all of you on this platform.
As an Innovation Product Development Officer at ProductLife Group (PLG), a life sciences consulting firm, I am deeply engaged in advancing regulatory science, particularly in RNA therapeutics and Immuno-Oncology. Since joining PLG in June 2023, I have been responsible for conducting comprehensive scientific and regulatory assessments, aligning our projects with EMA and FDA guidelines.
I actively collaborate with startups, universities, and biotech companies to spearhead cutting-edge research and development initiatives. My role includes managing scientific follow-ups and developing methodological frameworks.
In addition, I coordinate digital projects in Regulatory Affairs and Life Sciences, ensuring that all software solutions meet stringent quality systems and regulatory standards.
I am Pharmacist & I have total 15 years experience in Pharmaceutical company. I worked 13 years in QC analytical section, and two years in AR&D section (running). I worked in Stability and Instrument section. As I am directly involved with the analytical activity, troubleshooting of Analytical Instruments and various analytical challenges.
As an enthusiastic Individual, I am always looking for the advancement of the technology and various cutting edge technology. I dream of a simple technology for Qualitative and Quantitative analysis of the molecules. I want to know more about practical implementation of PAT and CM.
I am an expert user of:
HPLC, Dissolution, RAMAN, NIR, UV, IR, XRD, ICP, AAS, Malvern, Polarimeter, Refractometer, Raman Microscope, IPC Instruments, all type of analytical activities of small molecule analysis.
My name is Yleana Lugo, and I’m excited to be joining this group! I bring over 17 years of experience in the pharmaceutical industry, with a PhD in Chemistry specializing in spectroscopic technology and PAT. My background includes working with PAT applications for IPC and RTR in both batch and continuous manufacturing environments, as well as involvement in regulatory submissions. I’m eager to stay current on new applications and regulations and look forward to collaborating with all of new.
I currently run Sentronic US Corp., which develops NIR PAT solutions targeted towards the pharmaceutical industry, with a particular focus on CM in OSD pharma manufacturing. Prior to that, I developed chemometric models and PAT implementation strategies as part of the Vertex Pharmaceuticals process analytical chemistry team.
Prior to my adventure in CM, I was a chromatographer. USP was a great resource for chromatographer and I'm optimistic they'll be just as successful as a knowledge center for CM!
Katie Baumer @ on — Edited @ on
Welcome to the Continuous Manufacturing Knowledge Center (CMKC) community! We're thrilled to have you as a member. The CMKC is a friendly online space for professionals to connect and discuss all things related to pharmaceutical continuous manufacturing. We want to provide an engaging, welcoming environment where CM professionals like you can learn, connect, and thrive.
Here are a few tips to help you get started:
To ensure a great experience, we encourage you to abide by the golden rule: use the community how you would want others to use it. If you're unsure what to post, consider how you would feel if you came across the post yourself. Would you find it interesting, friendly, and welcoming? If you need assistance crafting a post, email us at cmkc@usp.org. We're here to help!
Once again, welcome to the CMKC community! We're excited to have you join us and look forward to your active participation.
Nathaly Movilla @ on
Hi everyone!
My name is Nathaly Movilla Meza and I'm a doctoral student of Chemistry in the University of Puerto Rico, at Mayaguez. My advisor is Dr. Rodolfo Romañach and I've been working with him since 2019 in things related with Continuous manufacturing and Process Analytical Technology (PAT).
Atul Dubey @ on
Hello world!
Nathaly, welcome to our CMKC. I hope you will find engaging discussions, great content and contribute to them!
Aubray Prevot @ on
Hi everyone,
I am a Marketing specialist working for different companies that are developing solutions for CM and especially to controle CQAs
I will be very delighted to share and debate around in-line/online QC processes applied for CM.
Thanks for welcoming me!
Aubray
Julie Yin @ on — Edited @ on
Hello everyone, my name is Julie and I work at USP Richmond AMT Lab-the newest analytical facility that USP just opened last Dec, and AMT lab is capable to provide PAT support of flow chemistry and continuous manufacturing to pharmaceutical industry partners, and I am very excited to join this CMKC community and looking forward to more engagement!
Sincerely
Julie
Cetin Cetinkaya @ on
Hi Everyone,
I am a professor of engineering at Clarkson University and a founder of a start-up company, Pharmacoustics Technologies, LLC.
My USP relevant interest is the applications of ultrasound and acoustics in CM, my focus is on the modernization of pharma manufacturing using advanced technologies, AI/ML, public blockchain technology as well as computer algebra and ultrasonics - of course-.
Below I include links to various aspects of my work, from research to teaching.
Çetin Çetinkaya, Professor and Jesanis Endowed Chair | (315) 268-6514 |
| Director, Photo-Acoustics Research Laboratory |
| Dept. of Mechanical and Aerospace Engineering |
| W. H. Coulter School of Engineering |
| Clarkson University | 8 Clarkson Ave. CAMP 241 Box 5725 |
| Potsdam, NY 13699-5725, USA |
|
| Spring 2023 Office Hours: Tuesday/Thursday 10:00-12:30 | By Appointment |
| Google Scholar Citations: |
scholar.google.com/citations?hl=en&user=Qcuq9QMAAAAJ&view_op=list_works&sortby=pubdate
| ResearchGate Profile: |
www.researchgate.net/profile/Cetin_Cetinkaya
| Patents/IP: |
patents.justia.com/inventor/cetin-cetinkaya
| Course Materials: ES223 and ME455 |
moodle.clarkson.edu/course/view.php?id=23824
www.engineeringvibration.com
SAKIBANDA RAJESH @ on
Hello everyone, my name is Rajesh and working at syngene international Ltd as Corporate Quality assurance, the company will provide the customer Research oriented(CRO),The services will provide to drug Development to Commercial scale with world class infrastructure and I am very excited to join this CMKC community and looking forward to more engagement! Reframe
Weidong Zhao @ on
Hello, Everyone,
I am a senior manager of Product Quality and Analytical Method group at Digital & Innovation (D&I) of USP. I understand relatively well about the need of analytics in drug manufacturing and am interested in advancing technologies that provide quick and sufficient information for development and manufacturing control. I am looking forward to participating discussions in these areas.
Vanesa Distaso @ on
Hi everyone!
My name is Vanesa Distaso, I am a Pharmacist and work in R&D, as a manager of pharmaceutical development.
We are not current using Continuous Manufacturing, but we are interesting in this technology. We are in a laboratory specialized in oral solid forms in Argentina.
I am looking foward to participate and learn a lot! Thanks, regards, Vanesa.
Rudi Oliveira @ on
Hi all,
I am a senior scientist working in process development and scale-up of APIs. I have started my flow / continuous journey over 8 years ago.
Looking forward to participate in this forum aiming to consolidate the use of continuous technologies in the pharmaceutical industry.
Cheers
Stefan Radl @ on
Hey,
i am a professor for chemical engineering with specialization in particle and fluid flow simulations. I am interested in food and pharma processes, and "going continuous" is certainly also challenging from a "flow perspective".
If you want to see what I teach, it is best to join this (free and open) MOOC: https://imoox.at/course/dem
Looking forward for exciting interactions!
cheers
Stefan
JITHENDRA KUMAR BASWA @ on
Hi I am Jithendra Baswa, I am Having 17 + years of experience in Pharmaceutical Microbiology, Sterility Assurance, Quality Management systems , Audit and compliance, QC laboratory compliance, Aseptic manufacturing Compliance in sterile Injectables ( Pharmaceutical injectables and vaccines)
Hibre Terefe @ on
My name is Hibre Terefe, Ph.D., Director of Research and Development, Clinical Development and Supply at Catalent Pharma Solution, a global CDMO at the Somerset, NJ site.
I am interested in Pharmaceutical Continuous Manufacturing and would like to expand my knowledge and expertise in this area. I believe this group is the right forum to exchange knowledge engage in discussions about PCM.
Looking forward for a vibrant discussion and knowledge exchange.
Thanks
Hirofumi Suzuki @ on
Hi everyone!
I'm Hirofumi Suzuki at Bayer Yakuhin Ltd. in Japan. I'm a member of Consortium of Continuous Pharmaceutical Manufacturing Japan (CCPMJ) and curious about Conitinuous Manufacturing.
Looking forward for exciting discussion.
Thank you.
Hirofumi
Hossein Birjandi Nejad @ on
Hi everyone.
My name is Hossein. I work at FDA. Below is the link to my LinkedIn profile and a brief bio. Looking forward to connecting and collaborating with you all.
--Hossein
-----------------------------------------------------------------------
LinkedIn Profile: www.linkedin.com/in/hosseinbirjandinejad
Bio: Hossein has more than 10 years of experience at the FDA, private sector and in academia related to investigation and research of pharmaceutical manufacturing. In his current role as program manager in the Advanced Medical Products Manufacturing (AMPM) team in Office of Regulatory Affairs (ORA) within FDA, Hossein oversees developing and implementing projects related to advanced manufacturing. In his previous roles, He has been recognized as a leading expert in several areas of AM utilized in development of novel medical products such as ophthalmic implants, drug products containing nanomaterials (e.g., mRNA containing liposomes), polymeric implants and drug-device combinations. Specific examples of advanced manufacturing techniques that Hossein has experience in include but are not limited to end-to-end continuous manufacturing (CM) of drug substances and drug products, investigation of process analytical controls (PATs), 3D printing, continuous extrusion/blending/granulation/tableting and model-based controlled strategies (e.g., digital twin).
Affan Ali @ on
Hi everyone,
This is Affan Ali, I am a pharmaceutical regulator from Pakistan, I have 10 years of experience in different aspects of pharmaceuticals and biologicals from manufacturing of biologicals, quality control of pharmaceuticals, quality systems and GMP inspections. Currently I am working with WHO as a consultant to support Medicine Control Agency, The Gambia.
My full profile can be viewed at Dr Affan Ali | LinkedIn
I am looking forward to learn and share my knowledge with this prestigious community.
Best Regards,
SAUD ALHWAIMEL @ on
Hi everyone,
I am Saud Alhwaimel am a pharmaceutical technical and regulator from Saudi Arabia, I have mor than 20 years of experience in local authority and local pharmaceutical company in different aspects of pharmaceuticals and biologicals.
Sujey Elizabeth Martinez Navarro @ on
Hello Everyone..!!!
I am Sujey., I work in phamaceutical laboratory as a regulatory affairs specialist. I am interested in advancing technologies and documentation that provide fast and sufficient information for development and manufacturing control.
Nivedita Jaiswal @ on
I am a scientist both by passion and profession having played a pro-active role in the academic institutions and research laboratories for over 10 years. Currently, I am striving to work in the filed of biopharmaceutics.
In terms of my academic background, I hold a PhD in Biochemistry from India and bring with me 5 years of postdoctoral research experience resulting into research papers of international repute. My PhD and postdoctoral research focused on screening, isolation, purification, extensive physico-chemical characterization, immobilization of thermostable enzymes like alpha-amylases and laccases and their exploitation for diverse industrial applications. In my most recent role, I served as a Scientist in a group focused on Novel Biologics and Biosimilars within the R&D industry in India. During this time, my responsibilities were extensive and multifaceted. My role required a high level of engagement in the analysis and interpretation of data related to protein/mAb characterization studies, and contributed in preparation of CMC documents for regulatory submission. Besides, preparation and review of other documents/reports like PDR, TTD, STP and SOP was also a part of my role.
Currently, I am also serving as an Academic Editor, Editorial Reviewer and also Section Editor (Special Issues) for several highly reputed research journals, thus adding my active contributions to the scientific community through participation in the scientific peer review process.
I have a keen interest in Continuous Manufacturing and am eager to enhance my understanding and skills in this field. I am confident that this group provides an ideal platform for sharing knowledge and participating in discussions related to PCM.
Olena Gligorich @ on — Edited @ on
I bring over 16 years of business and biotechnology industry leadership experience to advise companies on how to achieve their goals through directing decision making and impeccable execution.
Currently at SomaLogic (now Standard BioTools), I am a Director of Program Management and lead the program management team responsible for high-profile complex life sciences programs and product commercialization.
At Invitae, I built the program management team focused on change management and integration of product and program development activities following the acquisition of an oncology diagnostics product portfolio.
As a founder and principal consultant at Forward Aspect, LLC I am passionate about providing strategic leadership on best practices of planning, business operations and execution for various organizations.
During my 5-year tenure at BioMeriux, formerly BioFire Diagnostics, I directed infectious disease IVD project pipeline across multiple departments.
Previously, I spent 6 years leading and performing due diligence assessment for a portfolio of early-stage ideas, technologies, licenses, start-up companies in the areas of life sciences, medical devices, software and engineering at the Technology & Venture Commercialization Office, University of Utah.
Apri Loui @ on — Edited @ on
Hello Friends and Colleagues!
I'm pleased to connect and partner with all of you in progressing very important topics in our industry. My career spans 29 years in global pharma/biotech includes Process Development, Manufacturing, Facility Start Ups, Regulatory, and Quality for large and small, clinical to commercial stage organizations, across multiple modalities and dosage forms.
I'm currently the SVP of Quality and CMC Regulatory at ReCode Therapeutics, enabling the development of mRNA lipidnanoparticles for rare diseases, and CEO of Clarity Global, LLC Consulting, delivering efficient strategies to organizations transitioning from clinical to commercial operations.
I look forward to engaging with all of you on this platform.
Very Best,
April
Linkedin: https://www.linkedin.com/in/awloui
Melissa Bou Jaoudeh @ on
Hi everyone,
As an Innovation Product Development Officer at ProductLife Group (PLG), a life sciences consulting firm, I am deeply engaged in advancing regulatory science, particularly in RNA therapeutics and Immuno-Oncology. Since joining PLG in June 2023, I have been responsible for conducting comprehensive scientific and regulatory assessments, aligning our projects with EMA and FDA guidelines.
I actively collaborate with startups, universities, and biotech companies to spearhead cutting-edge research and development initiatives. My role includes managing scientific follow-ups and developing methodological frameworks.
In addition, I coordinate digital projects in Regulatory Affairs and Life Sciences, ensuring that all software solutions meet stringent quality systems and regulatory standards.
Best regards,
Sharmin Afroz @ on
Hello Everyone,
I am Pharmacist & I have total 15 years experience in Pharmaceutical company. I worked 13 years in QC analytical section, and two years in AR&D section (running). I worked in Stability and Instrument section. As I am directly involved with the analytical activity, troubleshooting of Analytical Instruments and various analytical challenges.
As an enthusiastic Individual, I am always looking for the advancement of the technology and various cutting edge technology. I dream of a simple technology for Qualitative and Quantitative analysis of the molecules. I want to know more about practical implementation of PAT and CM.
I am an expert user of:
HPLC, Dissolution, RAMAN, NIR, UV, IR, XRD, ICP, AAS, Malvern, Polarimeter, Refractometer, Raman Microscope, IPC Instruments, all type of analytical activities of small molecule analysis.
Yleana Lugo @ on — Edited @ on
Hello Everyone,
My name is Yleana Lugo, and I’m excited to be joining this group! I bring over 17 years of experience in the pharmaceutical industry, with a PhD in Chemistry specializing in spectroscopic technology and PAT. My background includes working with PAT applications for IPC and RTR in both batch and continuous manufacturing environments, as well as involvement in regulatory submissions. I’m eager to stay current on new applications and regulations and look forward to collaborating with all of new.
Owen Rehrauer @ on
Hello everyone,
I currently run Sentronic US Corp., which develops NIR PAT solutions targeted towards the pharmaceutical industry, with a particular focus on CM in OSD pharma manufacturing. Prior to that, I developed chemometric models and PAT implementation strategies as part of the Vertex Pharmaceuticals process analytical chemistry team.
Prior to my adventure in CM, I was a chromatographer. USP was a great resource for chromatographer and I'm optimistic they'll be just as successful as a knowledge center for CM!