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Solving Process Challenges Requires Flexibility To Explore Alternative Analytical Methods
Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products.
Breaking News
|
Clinical Trial Materials
|
Drug Development
|
Industry News
|
Scale-up/Technology Transfer
USP Offers Support for COVID-19 Antiviral/Vax Developers
Aims to help developers ensure quality of their materials as they scale up manufacturing to bring products into clinical development.
03.19.20
Breaking News
|
Chemistry
|
Drug Development
|
Industry News
|
Information Technology
Pistoia Alliance’s UDM Project Reaches Milestone
Latest UDM helps build comprehensive data model for chemical reactions to support Lab of The Future and AI adoption
02.25.20
Bio News
|
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Collaborations & Alliances
|
Industry News
3P Bio, In3Bio Enter Cancer Pact
New anti-tumor treatment is one step closer to the clinic on heels of new collaboration.
11.28.19
Bioanalytical Services
|
Clinical Trials
|
Industry News
|
Laboratory Testing
Recipharm Divests Bioanalysis Biz
Expands existing partnership with CTC Clinical Trial Consultants AB.
11.04.19
Planning Is Everything - Quality Control Testing in Cell and Gene Therapy
...
Novel Analytical Methods for Characterization and Lifecycle Management
...
10.28.19
A Witness to the Growth of Outsourcing
Observations from the 2019 Contract Pharma Conference.
Emil W. Ciurczak, DoraMaxx Consulting
10.15.19
Biologics, Proteins, Vaccines
|
Facilities
Fujifilm Eyes Being ‘Total Healthcare Company’
Invests nearly $900 million to acquire Biogen’s manufacturing hub in Denmark.
Tim Wright, Editor, Contract Pharma
10.15.19
Clinical Trial Materials
Overcoming the Small Molecule Bioavailability Challenge
Approximately 90% of preclinical compounds are estimated to face bioavailability challenges.
David Lyon, Sr. Research Fellow, Lonza Pharma & Biotech
10.15.19
APIs
Better Drug Manufacturing Strategies: Custom APIs
Today’s biopharma companies are turning to their contractors for long-term collaboration and much higher levels of support.
Tom Wilson, VP, Global Contract Manufacturing Leader, Pfizer CentreOne
10.15.19
Biopharmaceuticals & Analytical Testing Technology
Analytical technology and processes are evolving as the biologics industry continues to grow.
10.01.19
Breaking News
|
cGMP Manufacture
|
Fill/Finish
|
Industry News
Minerva, Catalent Enter Long-Term Commercial Supply Pact
Catalent will manufacture and package the finished dose form of Roluperidone at its facility in Schorndorf, Germany
09.24.19
Chemistry
|
Industry News
|
Laboratory Testing
CMC Pharmaceuticals Launches cGMP Lab Services
Addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines
09.17.19
Drug Discovery
Drug Discovery Technology Trends
Combining native mass spectrometry with fragment-based drug discovery in medicinal chemistry
Sally-Ann Poulsen, Professor of Chemical Biology, Griffith Institute for Drug Discovery (GRIDD), Griffith University
09.16.19
Validation
Pharmaceutical Process Validation: Product Quality, Safety and Efficacy
Validation must happen at each step of a manufacturing process.
Robert Glaser, CTO, Auvesy, Inc
09.16.19
APIs
|
Scale-up/Technology Transfer
Drug Substances: Scale-Up Challenges
A look at the necessary steps and evaluations needed in order to manage complexities and reduce timelines.
Anders Högdin, Senior Sales Director, Recipharm
09.16.19
QA/QC
|
Validation
Considerations for Analytical Method Validation Lifecycle Controls
ICH is set to implement new regulatory guidance dedicated to analytical method development
Paul Mason, PhD, Lachman Consultants
07.15.19
Promotions & Moves
Avomeen Appoints Head of Elemental Analysis
Mr. Ferencz will help clients comply with regulations such as USP 232 and USP 233, as well as California Proposition 65
06.17.19
QA/QC
Nitrosamines
How to address these unwelcome guests in the pharmaceutical world
Aloka Srinivasan, Ph.D., Lachman Consultant Services
05.07.19
Clinical Trial Materials
Clinical Manufacturing on Time and within Budget
The key to successful development and guiding a drug to approval is early planning.
David Brett, Team Leader Product and Service Management, Vetter
04.05.19
Scale-up/Technology Transfer
Scaling-Up Suspensions
A look at equipment and ingredient challenges with technical transfer and scale-up of suspensions.
Angela Holley, WDPrx; Robert Falconer, Falcon Pharma
04.05.19
Chemistry
|
Inspections
|
Microbiology
|
Process Validation
|
Regulatory Affairs
|
Supply Chain
|
Validation
Support Services
...
Bio News
|
Breaking News
|
cGMP Manufacture
|
Facilities
Goodwin Biotechnology Expands Capacity
Invests in doubling space available for cGMP capacity as it readies for further expansion of its biopharma manufacturing business
03.08.19
Drug Development
|
Preclinical Outsourcing
Early Development Trends
Catalent’s president of oral drug delivery, Jonathan Arnold, talks trends and challenges in the early phases of drug development.
Tim Wright, Editor, Contract Pharma
03.06.19
Biologics, Proteins, Vaccines
Preparing For Your CDMO Selection Process
Five questions that must be answered before starting your CDMO search.
Ajinomoto Bio-Pharma Services
03.06.19
Bio News
|
Bioanalytical Services
|
Biologics, Proteins, Vaccines
|
Breaking News
|
Industry News
|
Process Development
3P Expands Analytical Capacities and Capabilities
Invests roughly $500K in area expansion and equipment upgrades
02.28.19
Bio News
|
Collaborations & Alliances
|
Drug Development
|
Industry News
|
R&D
Idifarma, Palobiofarma Enter Partnership
Under the agreement, Idifarma will handle the full pharmaceutical development of Palobiofarma’s PBF-2897
10.26.18
Bio News
|
Drug Development
|
Drug Discovery
|
Facilities
|
Industry News
|
R&D
KBI Biopharma BVBA Launches Belgium Lab Operations
Labs are co-located with JSR Life Sciences’ Amsphere A3 European mfg. site & represent KBI’s first Europe service offerings
08.29.18
Bio News
|
Collaborations & Alliances
|
Drug Development
|
Industry News
Gyros, Cygnus Sign Agreement
To enable the development of new Gyrolab immunoassay kits to further support customers working in biotherapeutics development
07.12.18
Information Technology
Putting Data Integrity in Quality Agreements
With growing regulatory scrutiny, sponsors are focusing more on data integrity in supplier quality agreements.
Robert Marohn, ClinLogic, LLC
06.12.18
Bio News
|
Breaking News
|
Clinical Trials
|
Collaborations & Alliances
|
Drug Development
|
Drug Discovery
GE, XPH Enter FlexFactory Agreement
To scale up, digitize & accelerate manufacturing processes for their cell therapy clinical trials & future commercialization
06.07.18
R&D
Newsmakers: Charles River
Charles River Expands
Kristin Brooks, Managing Editor
05.07.18
Halo Pharma to Highlight Topical Drug Product Capabilities
Global pharmaceutical companies outsource topical products to the growing CDMO
04.18.18
Bioanalytical Services
|
CRO News
|
Facilities
|
Industry News
SGS Launches New Large Molecule Bioanalytical Services
8,400-square meter lab includes the installation of Sciex instruments
12.07.17
Analytical Services
|
Methods Development
Analytical Method Transfer Best Practices
Avoiding the perils of analytical method transfer
Wayland Rushing, Director, Scientific Affairs, EAG Laboratories
11.07.17
Analytical Methods for Predicting Protein Stability in Lyophilized Formulations
...
11.07.17
Drug Development
|
Drug Discovery
AAPS Annual Meeting Preview
Sessions address Pharmaceutical Excipients, Emerging Partnership Models, Drug Delivery Strategies, and more
Online Exclusives
11.01.17
Drug Development
Making Medicines: Speeding the Path from Idea to Patient
Speeding the path from idea to patient
Dan Bowles and Michael Tracey, Cambrex
10.11.17
GMPs/GCPs
What are GMPs?
And why do we need them in contract work?
Emil W. Ciurczak, DoraMaxx Consulting
09.06.17
Cytotoxics and High Potency Manufacturing
High Potency APIs: Some Bad News, Some Good News
The growing use of HPAPIs has created some challenges in the lab, while at the same time offering advantages as well.
Emil W. Ciurczak, DoraMaxx Consulting
07.18.17
cGMP Manufacture
|
Solid Dosage/Creams/Ointments
Newsmakers: Lee Karras
Meeting the demand for pediatric dosage forms
06.06.17
Bioanalytical Services
Current Trends in Analytical Testing
Improved analytical methods continues to be a current need for nearly every aspect of biopharma manufacturing
Eric S. Langer, BioPlan Associates
05.09.17
cGMP Manufacture
|
Promotions & Moves
Berkshire Sterile Manufacturing Names QC VP
Wigington to assume responsibility for analytical and microbiological activities
04.11.17
Reality and Un-Reality: Continuous Processing in Pharmaceutical Manufacturing
...
Girish Malhotra, President, EPCOT International
04.03.17
Analytical Services
|
Industry News
AMPAC Quadruples Analytical Services Capacity
Adds 13,000 sq.-ft. of new lab space
03.30.17
Chemistry
|
Drug Development
Know Your Drug: A Solution to Dissolution
Examining key strategies for solubility and dissolution assessment of new drug products, drug product intermediates and APIs
Luís Sousa, Mafalda Paiva and Pedro Serôdio, Hovione
03.07.17
Bioanalytical Services
|
Industry News
Sartorius to Acquire Essen BioScience
Expands bioanalytics portfolio with cell analysis platform for research and drug discovery
03.03.17
APIs
|
Chemistry
|
Cleaning Validation
|
Clinical Trials
|
Toxicology
|
Validation
Limiting APIs in Manufacturing Effluent
An approach for setting limits on pharmaceuticals discharged in manufacturing effluent
Joan Tell, Robert Drinane, Bruce Naumann, Jessica Vestel, and Gregory Gagliano, Merck & Co., Inc.
06.02.16
Capsules
|
Validation
Sometimes You Need to Spend to Save
Exploring the importance of investing to develop new analytical methods
Emil W. Ciurczak, DoraMaxx Consulting
05.05.16
Breaking News
Immunome Promotes Max Rosett to Chief Financial Officer
Siren Biotechnology, Catalent Partner for Manufacturing of AAV Gene Therapies
Nuvalent’s NVL-655 Granted Breakthrough Therapy Designation by FDA
Johnson & Johnson Agrees to Acquire Proteologix
Veranova, Phorum.AI Partner on Generative AI Chemistry Optimization
View Breaking News >
CURRENT ISSUE
May 2024
CDMOs: The Cornerstone of Biopharmaceutical Innovation
Pharma 4.0: CDMOs Digitalize to Enhance Customer Value
CEO Spotlight: Gaston Salinas
Parenteral Perspectives
The Transformative Potential of Gene Therapy
Creating Solutions for CDMOs: An EPCMV Firm’s Perspective
Single-use Fermenters for Microbial Biopharma Development & Manufacturing
View More >