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Expert content
- “At the end of the day, it is all about the patient”…
- 3D packaging rendering services
- 40 years at Sharp- a retrospective
- 7 key questions to consider for your next IND application
- A 20-year retrospective into the development of clinical trials
- A day in the life – Eddy Boom
- A day in the life – Emy Betten
- A day in the life – Sijmen Kingsbergen
- A day in the life – Sweitse de Wit
- A Day in the Life… Project and Sales Support
- A media fill validation approach to a flexible filling line
- A Quick Guide to Transferring a Commercial Drug Product to a New Fill Finish CMO
- A validation approach to a multiple equipment complex filling line
- A VHP validation approach to a multi chamber and complex flexible filling line with Q&A
- Addressing the challenges of packaging OSD and powder products with low humidity
- Adopting robotics automation and software
- An Introduction to Isolator Technology
- Analytical Formulation: What formulators must know about particle size reduction
- Analytical testing: Ten questions that accelerate drug development
- Aseptic Filling Challenges for Intravitreal Drug Products
- Aseptic filling of unstable drug products
- Aseptic Filling Techniques for Highly Viscous Drug Products
- Autoinjector assembly, labeling and packaging: Important questions to consider ensuring a successful autoinjector launch program
- Automated Vial Filling
- Automated Vial Filling & Lyophilization
- Beyond Lipids: The Science of LNP Manufacturing and Fill Finish
- Building flexibility into isolator-based filling lines
- Cartridge Filling on Semi-Automated Filling Line
- Challenges in Filling for Alum Drug Products: What Does a CDMO Need to Successfully Fill Alum Drug Products?
- Choosing the right clinical trial solution for distribution and supply optimization
- Clinical trial and commercial packaging trends and predictions
- Clinical trial challenges in China: How a Sharp and ClinsChain pairing is breaking down barriers
- Communicating occupational hazards through color
- Considerations for clinical packaging that will impact commercial-scale success
- Container Closure Integrity Testing (CCIT): New FDA Guidelines and What They Mean
- Container Closure Integrity Testing (CCIT): What you need to know
- COVID-19: A catalyst for change in global clinical trials
- Creating flexibility and efficiency in isolator-based filling with robotics and automation
- Current trends in the solid dose manufacturing and packaging arena
- Cutting losses in drug manufacturing: A new era in fill-finish technology
- De-risking clinical trial supply with an ‘all-under-one-roof’ solution
- Demystifying the role of the QP in the clinical trial supply chain
- Demystifying the role of the QP in the clinical trial supply chain
- Design and construction of a complex intramuscular injectable kit
- Develop and execute a winning drug launch strategy
- Developing an Efficient Pharmaceutical Secondary Packaging Approach for New Drugs
- Developing sustainable solutions to clinical trial packaging
- Digital transformation of batch records enhancing efficiency & compliance
- Disparity danger: feeling ready vs being ready for serialization
- Double Materiality in Sustainable Medicine Packaging
- Earth Day 2021: Reflecting on our collective environmental responsibility
- Earth Day 2022 – The best time to plant a tree was twenty years ago
- Eddy Boom: Line lead production
- Embedding continuous improvement in clinical services and commercial drug packaging
- Emy Betten: Projectcoördinator Clinical
- End-to-End Production at Sharp
- Energy and Expertise transform the outlook for Sharp Europe
- Engineering runs in fill finish: what are they and are they necessary?
- Enhancing quality and efficiency through digitized clinical secondary packaging processes
- Everything you need to know about Labeling, Kitting, Storage, and Distribution
- Expanding and ensuring continuity of service for ROWA Pharmaceuticals Ltd
- FAQs – Sharp expands its clinical operations to European facility
- Flex-filling and temperature controlled distribution solutions for your injectable drug product
- From Bench to Bedside: The Journey of Oligonucleotide Drug Development and Sterile Filling
- Fully automated sterile filling line
- Fundamentals of Developing Parenteral Drug Products
- Getting your product to the patient: what to know about labeling, kitting, storage, & distribution
- How to leverage clinical IRT to improve clinical trial efficiency
- Improving efficiency in ampoule packaging and labeling lines
- Introducing AI in the pharma supply chain is a journey
- Introducing the Future of Sterile Filling
- IRT or Inventory Management System (IMS)?
- IRT/RTSM: Key factors you need to know before choosing a solution for your trial
- Issues, developments and the future of primary packaging
- Leveraging commercial packaging expertise early to ensure successful scaling from the clinical stage
- Low-Loss Fill Process
- Low-volume / small-batch packaging challenges (in both the US and EU)
- Managing Temperature-Sensitive Drug Products in Fill Finish Operations
- Manual Filling Line
- Mapping the optimal supply chain for biologics, from formulation to clinic
- Mastering Lyophilization: Overcoming development and optimization challenges
- Minimizing volume losses in small-scale aseptic fill finish for high-value drug products
- Navigating Direct-to-Patient Clinical Trials: Distribution Challenges and Solutions
- Navigating the Fill Finish Process: A Step-by-Step Guide
- Navigating the trends and transformations of 2024
- Need for speed: the key to successful multi-market product launches
- New Qualified Person oversight regulations when importing IMP to the UK
- No Batch Too Small: Choosing the Right Fill-Finish CDMO for Small-Scale Batches
- No loose ends: Efficient and trusted pathways for launching drugs to market
- Optimizing Oligonucleotide Drug Products: Strategies for Formulation, Lyophilization, and Fill Finish Processes
- Optimizing your CDMO/CPO network for serialization
- Optimizing your direct-to-patient clinical trial logistics
- Overcoming Common Challenges in Fill Finish for Monoclonal Antibodies (mAbs)
- Overcoming Technical Challenges in Gene Therapy Product Fill-Finish Operations
- Q&A: Comparator and co-therapy drug sourcing for clinical studies
- Q&A: Körber’s Dividella NeoTOP x toploading system
- Quick Start Guide
- Rare Disease Day – 28 February 2018
- Reducing loss in fill finish for high-value drug products
- Reducing our carbon footprint: reducing plastics in our injectables packaging process
- Roadmap to a successful drug launch
- Robotic Filling of Syringes
- Secondary packaging for sterile injectables: Overcoming today’s design challenges
- Semi-Automated Filling Line
- Serialization 2.0 – what’s next?
- Serialization: Best practice for packaging line and site readiness
- Serialization: How Sharp responds to market demands
- Sharp – Leadership Q&A – BSM Acquisition
- Sharp and Braeburn win industry recognition for compliance packaging
- Sharp believes in… giving back
- Sharp believes in…employee welfare
- Sharp Clinical Services – improving, transforming, growing
- Sharp delivers a serialized packaging solution for the launch of Radicava for Mitsubishi Tanabe Pharma America
- Sharp Global Design Center sees a growing demand for kit design and serial number code customization
- Sharp ingenuity in clinical manufacturing reduces the duration and complexity for Phase III trial
- Sharp optimizes FOCUS clinical supply chain to ensure zero waste
- Sharp partners with Systech to deliver a revolutionary non-additive product authentication and supply chain security solution
- Sharp switches to CREDO boxes
- Sharp UK celebrates 30 years delivering clinical trial services
- Sharp UK extends offering to deliver medical device commercialization
- Sharp’s roadmap for a journey in lean leadership
- Sijmen Kingsbergen: Projectengineer Serialization
- Solar investment improves environmental performance and brings energy savings to Sharp
- Successful clinical supply strategies for solid oral dose trials
- Supporting Client Launches During COVID-19
- Supporting commercial gene therapies – transforming to patient-led demand model
- Supporting Staidson Biopharma’s EU clinical trials in COVID-19 lockdown
- Supporting the rapid launch of pharmaceutical and biopharma products
- Sustainability in Packaging Solutions: Unpacking Materiality and Climate Change Terminology
- Sweitse de Wit: Warehouse medewerker
- Syringe Filling on Semi-Automated Filling Line
- Technology and innovation: developing virtual audits in the pandemic
- The ABCs of Formulation Development
- The benefits of automation in clinical trials
- The essential role of Interactive Response Technology (IRT) in clinical trial supply
- The evolution of contract packagers: Delivering sustainability for injectables packaging
- The Future of Small Scale Sterile Filling Webinar Kickoff
- The new online technique for IPC and other advanced filling technologies
- The pros and cons of pooling supplies for clinical trials
- The role of QPs in meeting the challenges of increasingly complex supply chains
- The role of the modern QP – evolving responsibilities and challenges
- The science of viscous drug product filling: Pumps, pressure, and process optimization
- The value of torque testing and determining best practice
- Transforming Sharp into a LEAN organization
- Trends in global drug supply: An interview with Sharp’s Kevin Orfan
- Unique Challenges of Specialty Container Sterile Filling
- Value Stream Mapping at Sharp
- Vial Filling on Semi-Automated Filling Line
- Visual Inspection
- What is an engineering run, and do you need one?
- What is the significance of the United Nations Global Compact?
- What’s Involved in Designing Effective Lyophilization Cycles?
- Where Drug Product is Lost in Fill Finish and How to Limit It
- Why automate your clinical inventory management?
- Why demand is rising for secure and climate-controlled gene therapy services
- Why implement aggregation alongside serialization now?
- Why Lean Management is simple but hard
- Why your container closure choice matters in sterile fill finish
Testimonials
Solutions
- Analytical Services
- Autoinjector & Pen Assembly, Labeling and Packaging
- Automated Filling Line
- Blisters: Primary and Secondary
- Bottles: Primary and Secondary
- Cartridge Filling
- Clinical Trial Technology Solutions
- Clinical Trials Storage and Distribution
- Clinteract
- Clinventory
- Comparator Drug Supply
- Contract Manufacturing
- Design Services
- Development
- Direct-To-Patient Solutions
- Disposable Pen Assembly and Packaging
- EU and UK Qualified Person Services
- Fill Lines
- Gene Therapy Clinical Trial Services
- Gene Therapy Commercial Packaging
- Injectables Packaging
- Kitting
- Labeling and Secondary Packaging
- Low Loss Manual Line
- Lyophilization Development
- Lyophilization Services
- Manual Filling Line
- Method Development
- Pen assembly
- Pharmaceutical Analytical Services
- Pharmaceutical Product Development
- Pouches and Sachets: Primary and Secondary
- Pre-Filled Syringe Assembly, Labeling and Packaging
- Primary Packaging
- Project Management for Clinical Services
- Project Management for Commercial Packaging
- Semi-Automated Filling Line
- Serialization and Aggregation
- Sharp Sterile Development Process & Approach
- Specialty Filling
- Stability Programs
- Sterile Filling Services
- Sterile Formulation Development Services
- Sterile Manufacturing
- Sterile Syringe Filling
- Sterile Vial Filling
- Sustainable Packaging Solutions
- Terminal Sterilization
- Vial Labeling and Packaging
- YpsoMate® Device Assembly, Labeling and Packaging
Events
Posts
Blog
Company News
- Berkshire Sterile achieves its first commercial drug approval by the FDA
- Berkshire Sterile adds non-destructive weight checks to their low-loss fill line
- Berkshire Sterile announces Dr. Xufeng Sun as Vice President of Formulation and Technology Transfer
- Berkshire Sterile awarded $185,000 in tax incentive awards for Job Growth
- Berkshire Sterile client receives FDA approval on product indicated to reduce risk of hearing loss for childhood cancer patients
- Berkshire Sterile debuts its innovative “low loss” GMP fill process
- Berkshire Sterile Enhances Data Integrity with New Data Management System
- Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
- Berkshire Sterile Manufacturing adds new IMA lyophilizer to support development work
- Berkshire Sterile Manufacturing Announces Plans to Expand Lyophilization Capacity
- Berkshire Sterile Manufacturing expands services to include R&D and Tox lot formulation and filling
- Berkshire Sterile Manufacturing opens sterility isolator for onsite sterility testing
- Berkshire Sterile Manufacturing purchases new equipment to offer improved analytical testing and expand their cGMP laboratory
- Berkshire Sterile Manufacturing, LLC Rebrands to Sharp Sterile Manufacturing, LLC
- Berkshire Sterile Provides a New Offering for Small Volume Filling
- Berkshire Sterile Secures Over $230,000 in Training Grants
- Berkshire Sterile to offer formulation, lyophilization, and method development services
- Berkshire Sterile to unveil new sterile filling line
- Berkshire Sterile validates new sterile fill process to significantly limit product loss
- Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process Receives FDA Green Light
- Sharp – Leadership Q&A – BSM Acquisition
- Sharp’s Emissions Reduction Targets Validated by Science Based Targets initiative
Customer resources
- All Sharp Packaging US facilities now landfill free
- Alnylam Pharmaceuticals partners with Sharp on packaging RNA interference (RNAi) therapeutics for Europe
- Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
- Berkshire Sterile Manufacturing Appoints New President
- Global pharma industry supplier to officially open £9.5 million facility in Rhymney
- Gov. Wolf Announces Packaging Manufacturer Bringing Hundreds of New Jobs to Lehigh Valley Region after Expanding with Third PA Location
- Introducing ClinsChain – Pharmaceutical Logistics and Distribution
- Sharp acquires Berkshire Sterile Manufacturing
- Sharp acquires Daiichi Sankyo Inc.’s pharmaceutical packaging facility in Bethlehem PA
- Sharp acquires stake in Berkshire Sterile Manufacturing
- Sharp Acquires US Pharmaceutical Packaging Facility
- Sharp Adds New Talent in Global Operations and Finance to Senior Leadership Team
- Sharp Adds New Talent with Clinical Leadership Appointments
- Sharp announces £9 million investment in European Clinical Services Centre of Excellence
- Sharp announces alliance with serialisation technology leaders TraceLink, Systech, Covectra and Domino
- Sharp announces preferred partner agreement with Berkshire Sterile Manufacturing
- Sharp announces strategic partnership with Santen Pharmaceuticals
- Sharp Appoints EU Qualified Person (QP)
- Sharp Appoints Grace Breen as SVP Global Quality
- Sharp appoints Kevin Orfan as President of Sharp Packaging US
- Sharp Appoints New Leader to its Global Clinical Services Business
- Sharp appoints Sascha Sonnenberg as Global Head of Business Development, Sharp Clinical Services
- Sharp begins validation phase of £9.5 million Clinical Services Centre of Excellence
- Sharp believes in… Giving back
- Sharp celebrates International Women’s Day
- Sharp Clinical broadens global client support with Business Development appointments
- Sharp Clinical Launches Direct-to-Patient Service With New Partnerships
- Sharp Clinical officially opens £9.5 million facility in Rhymney
- Sharp Clinical Services welcomes Dave Wilson as Head of Operations
- Sharp Clinical Supports Development of Novel COVID-19 Vaccines and Treatments
- Sharp completes first phase of $23 million investment in Clinical Services facility
- Sharp completes relocation to $23 million clinical services facility in Bethlehem, PA
- Sharp enhances clinical IRT solution with latest investment
- Sharp expands clinical services operations at its EU Heerenveen facility
- Sharp Expands Commercial Packaging Capabilities to UK Facility
- Sharp Expands its Clinical Operations to European Facility
- Sharp Expands its Commercial Capabilities to UK Facility
- Sharp expands its reach to China through partnership with ClinsChain
- Sharp has achieved landfill-free status across its global facility network
- Sharp implements cloud-based QMS and strengthens quality leadership
- Sharp investing $11m in injectable and cold chain capabilities
- Sharp invests $10M in biologics and injectables packaging equipment
- Sharp invests $21M to expand US packaging capacity and capabilities
- Sharp Invests In New Gene Therapy Packaging and Distribution Capacity at EU Heerenveen Facility
- Sharp joins the Science Based Targets initiative (SBTi) to set greenhouse gas emissions reduction targets
- Sharp Joins the United Nations Global Compact
- Sharp launches Clinventory Inventory Management System (IMS) for clinical trials
- Sharp purchases new land as part of $17 million capacity expansion
- Sharp receives MHRA approval for Clinical Services Centre of Excellence
- Sharp selects TraceLink to achieve DSCSA compliance for 100+ pharmaceutical manufacturers
- Sharp selects Werum IT Solutions as strategic MES partner
- Sharp Services announces expansion in Pennsylvania to facilitate growth in sterile injectable market
- Sharp Statement on the Impact of COVID-19 (Dutch)
- Sharp Strengthens Senior Leadership Team with Two Appointments
- Sharp Supports UNICEF
- Sharp UK celebrates 30 years delivering clinical trial services
- Sharp welcomes the EU Falsified Medicines Directive to advance pharmaceutical authentication and patient safety
- Supporting Client Launches During COVID-19: Sharp Packaging US Supports Launch of Two Cancer Therapies
Drug Product Development
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Equipment
- Berkshire Sterile Enhances Data Integrity with New Data Management System
- Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
- Berkshire Sterile Manufacturing adds new IMA lyophilizer to support development work
- Berkshire Sterile Manufacturing purchases new equipment to offer improved analytical testing and expand their cGMP laboratory
- Berkshire Sterile Provides a New Offering for Small Volume Filling
- Berkshire Sterile validates new sterile fill process to significantly limit product loss
Growth
- Berkshire Sterile announces Dr. Xufeng Sun as Vice President of Formulation and Technology Transfer
- Berkshire Sterile awarded $185,000 in tax incentive awards for Job Growth
- Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
- Berkshire Sterile Manufacturing adds new IMA lyophilizer to support development work
- Berkshire Sterile Manufacturing Announces Plans to Expand Lyophilization Capacity
- Berkshire Sterile Manufacturing expands services to include R&D and Tox lot formulation and filling
- Berkshire Sterile Manufacturing purchases new equipment to offer improved analytical testing and expand their cGMP laboratory
- Berkshire Sterile Secures Over $230,000 in Training Grants
- Berkshire Sterile to offer formulation, lyophilization, and method development services
- Berkshire Sterile validates new sterile fill process to significantly limit product loss
In The News
- Berkshire Sterile awarded $185,000 in tax incentive awards for Job Growth
- FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat ‘Butterfly Children’
- Patient with Second Historic Pig Heart Transplant Treated with Novel Investigational Antibody Therapy Produced at Berkshire Sterile Manufacturing
News
- All Sharp Packaging US facilities now landfill free
- Alnylam Pharmaceuticals partners with Sharp on packaging RNA interference (RNAi) therapeutics for Europe
- Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
- Berkshire Sterile Manufacturing Appoints New President
- Global pharma industry supplier to officially open £9.5 million facility in Rhymney
- Gov. Wolf Announces Packaging Manufacturer Bringing Hundreds of New Jobs to Lehigh Valley Region after Expanding with Third PA Location
- Sharp acquires Berkshire Sterile Manufacturing
- Sharp acquires Daiichi Sankyo Inc.’s pharmaceutical packaging facility in Bethlehem PA
- Sharp acquires stake in Berkshire Sterile Manufacturing
- Sharp Acquires US Pharmaceutical Packaging Facility
- Sharp Adds New Talent in Global Operations and Finance to Senior Leadership Team
- Sharp Adds New Talent with Clinical Leadership Appointments
- Sharp announces £9 million investment in European Clinical Services Centre of Excellence
- Sharp announces alliance with serialisation technology leaders TraceLink, Systech, Covectra and Domino
- Sharp announces preferred partner agreement with Berkshire Sterile Manufacturing
- Sharp announces strategic partnership with Santen Pharmaceuticals
- Sharp Appoints EU Qualified Person (QP)
- Sharp Appoints Grace Breen as SVP Global Quality
- Sharp appoints Kevin Orfan as President of Sharp Packaging US
- Sharp Appoints New Leader to its Global Clinical Services Business
- Sharp appoints Sascha Sonnenberg as Global Head of Business Development, Sharp Clinical Services
- Sharp begins validation phase of £9.5 million Clinical Services Centre of Excellence
- Sharp Clinical broadens global client support with Business Development appointments
- Sharp Clinical Launches Direct-to-Patient Service With New Partnerships
- Sharp Clinical officially opens £9.5 million facility in Rhymney
- Sharp Clinical Services welcomes Dave Wilson as Head of Operations
- Sharp completes first phase of $23 million investment in Clinical Services facility
- Sharp completes relocation to $23 million clinical services facility in Bethlehem, PA
- Sharp enhances clinical IRT solution with latest investment
- Sharp expands clinical services operations at its EU Heerenveen facility
- Sharp Expands Commercial Packaging Capabilities to UK Facility
- Sharp Expands its Clinical Operations to European Facility
- Sharp Expands its Commercial Capabilities to UK Facility
- Sharp expands its reach to China through partnership with ClinsChain
- Sharp has achieved landfill-free status across its global facility network
- Sharp implements cloud-based QMS and strengthens quality leadership
- Sharp investing $11m in injectable and cold chain capabilities
- Sharp invests $10M in biologics and injectables packaging equipment
- Sharp invests $21M to expand US packaging capacity and capabilities
- Sharp Invests In New Gene Therapy Packaging and Distribution Capacity at EU Heerenveen Facility
- Sharp joins the Science Based Targets initiative (SBTi) to set greenhouse gas emissions reduction targets
- Sharp Joins the United Nations Global Compact
- Sharp launches Clinventory Inventory Management System (IMS) for clinical trials
- Sharp purchases new land as part of $17 million capacity expansion
- Sharp receives MHRA approval for Clinical Services Centre of Excellence
- Sharp selects TraceLink to achieve DSCSA compliance for 100+ pharmaceutical manufacturers
- Sharp selects Werum IT Solutions as strategic MES partner
- Sharp Services announces expansion in Pennsylvania to facilitate growth in sterile injectable market
- Sharp Strengthens Senior Leadership Team with Two Appointments
- Sharp UK celebrates 30 years delivering clinical trial services
- Sharp welcomes the EU Falsified Medicines Directive to advance pharmaceutical authentication and patient safety
- Supporting Client Launches During COVID-19: Sharp Packaging US Supports Launch of Two Cancer Therapies
Sterile Filling
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White Paper
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