VIDEOS AND WEBINARS

• The Fundamental Outsourcing Question All Sponsors Face

  To end our Outsourced Pharma Live event on strategies for quality and regulatory outsourcing challenges, Chief Editor Louis Garguilo emphasizes the crucial question to ask when selecting a CDMO.

• How To Connect Quality And Regulatory “At The Hip”

  Our Outsourced Pharma Live panel of experts introduce challenges and strategies to ensure your internal – and external partners’ – quality and regulatory professionals work together.

• File First In Europe, Then The U.S.?

  Karla Knower, Global Head of Regulatory Affairs, Paradigm Biopharmaceuticals, answers a challenging question from an attendee at a recent Outsourced Pharma Live.

• The Nature Of Quality Management Needs To Change

  In these 3 minutes, Bikash Chatterjee, an Outsourced Pharma Board Member, discusses how the current drug development and manufacturing landscape necessitates different approaches for quality teams.

• The Wrong Way For Your CDMO To Upgrade Facilities

  Christine Feaster, who has worked for top 50 pharma and start-up organizations, relates a case study as a warning to sponsors when CDMOs look to upgrade facilities and add capabilities.

• Today’s Quality And Regulatory Workforce Challenges

  Erin O'Brien (Biogen), Christine Feaster (QxP), and Bikash Chatterjee (Pharmactech Associates) discuss new workforce realities and tactics at sponsors and CDMOs that followed the "great resignation."

• Quality Agreements, Inspections, And PQS

  Karla Knower of Paradigm Biopharmaceuticals informs Outsourced Pharma Live attendees about quality agreements, inspections, and implementing a Pharmaceutical Quality System (PQS).

• Accelerated Approval Pressures Starting Materials

  Our panel of outsourcing experts discuss the need for speed in today’s development of drugs and therapies, and how that impacts the quest for and maintenance of quality starting materials.

• The Outsourcing Context Has Changed. Have You?

  Bikash Chatterjee, Pharmatech Associates explains how the scope of quality, regulatory, technical, and CMC development professional has changed dramatically.

• Managing Multiple Partners – And Materials – From Around The Globe

  Two development and manufacturing outsourcing professionals – one based in Australia and one the east coast of the U.S. – begin our discussion on global outsourcing.

• Workforce Challenges Key To Outsourcing

  Christine Feaster of QxP Consulting starts our discussion by focusing on a key to various realms of outsourcing: today’s workforce.

• Small Molecule APIs: From Pre-RSM To Final API

  As a leader in small molecule manufacturing, Ajinomoto Bio-Pharma Services has over 40 years of experience providing high quality APIs and intermediates for pharmaceutical companies throughout the world.

• Ajinomoto Bio-Pharma Services Capacity Update June 2023: Cell & Gene

  Ajinomoto Bio-Pharma Services is a leading provider in biologics manufacturing, using patented technologies and providing impeccable quality for 25 years. We specialize in cGMP plasmid production including for vaccine and gene therapy applications.

• Ajinomoto Bio-Pharma Services Capacity Update June 2023: Small Molecule

  Discover how Ajinomoto Bio-Pharma Services' new labs, flow units, and expanded capacity can help you to fulfill all your small molecule needs.

• Ajinomoto Bio-Pharma Services Capacity Update June 2023: Biologics

  Ajinomoto Bio-Pharma Services is a leading provider of biopharmaceutical CDMO services. Learn about the new high speed multi-purpose fill finish line in Aji’s commercial manufacturing facility located in San Diego, CA.

• CDMOs Will Tell You Anything. What Are You Telling Them?

  How do you know when CDMOs are overstating their case? Our panelists remind us, we need to be careful not to overstate our case to the CDMOs as well.

• Your CDMO As Consultant

  How consultative should CDMOs be? How much advice should you take in? How should you work with independent consultants? Our panelists consider the subject of CDMO as consultant.

• Just Ask The Question!

  Praveen Prasanna can’t recall the number of times he’s advised colleagues when they are concerned or wondering about a service, technology, timeline, or specific development, “Just ask the question!”

• Subjective And Quantitative Analysis Of Your External Partner

  Hear great advice from Jo Anne Valentino on turning what appear as more subjective criteria for judging contract partners into quantifiable analysis.

• CDMO Pricing For Viral Vectors And Cell & Gene Services

  Kenneth Lock of Carisma Therapeutics relates his experiences when it comes to costs and pricing from CDMOs in the CGT industry and shares insights on transparency and partner relationships.

• The Final Decision: Who Selects The Winning CDMO?

  Three of our experienced professionals weigh in, in detail, on who within the drug organization makes the ultimate decision when selecting a CDMO, and some aspects around that decision.

• Make Your RFP Work For You

  Putting the time and effort into the request for proposal or request for information so it clarifies what exactly is being asked of the CDMO is essential.

• Understanding Must Haves And Nice To Haves

  The services or data that might be nice to have need to be balanced with the resources needed for those that must be completed or delivered for project success.

• Our All-Star Panel All Start With A Key Point On CDMO Selection

  Chief Editor Louis Garguilo points out an interesting thread running through each of the professionals on the panel for the Outsourced Pharma Live: Which CDMO Is Best For You?

• Transactional Or Relational? Both Can Work Out With Your CDMO

  Jo Anne Valentino of JAValentino Consulting (and former Novartis Executive Director) speaks about relationships, partnerships, cultural fits and other key elements for getting it right with your CDMO.

• Looking for An External Partner Starts With An Internal Investigation

  Kenneth Locke, Carisma Therapeutics starts looking at the real needs and objectives of his own organization before turning outwards to select the best CDMO.

• Top 3 Factors For Working Successfully With CDMOs

  Marty Hughes, Cidara Therapeutics explains the most important factors for a CDMO relationship: How much development do you need? Who is the project manager? Is there new technology?

• Opening Thoughts On Selecting Your CDMO

  Watch Chief Editor Louis Garguilo’s Intro To Outsourced Pharma Live: What CDMO Is Best For You?, and meet the panel of experts discussing best practices for CDMO selection.

• Providing Value Optimized, Time Saving Oligo Solutions

  Whether you are in the beginning research stages or ready to take your product to market, our scalable, high quality, and custom oligo and peptide solutions provide the quantities you need using the most reliable, robust, and cost-effective process available.

• Rising To Meet Increasing Demand For Microbial Based Biologics

  The production of your biotherapeutic deserves the reliability and peace of mind that only a trusted and experienced microbial fermentation partner can provide. Ajinomoto Bio-Pharma Services is a recognized leader in recombinant protein, plasmid DNA, and critical raw material manufacturing for vaccine and gene therapy applications.

• Custom Pharmaceutical Packaging, Labeling And Shipping Services

  Consolidate your supply chain by having your packaging integrated with your product manufacturing.

• Aseptic Vial Filling

  We offer a unique range of formulation and aseptic filling in vials, prefilled syringes or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

• Aji Bio-Pharma and Catalisti

  The HANU, a new photo-flow reactor, provides better process control, less risk in hazardous chemistry, less solvent use, and is better for the environment.

• New High Speed Multi-Purpose Fill Line

  Our fully contained and integrated OPTIMA line utilizes scan isolated barrier technology to ensure the required sterility for fill finish while offering flexibility to meet your cGMP, clinical, and commercial drug product manufacturing needs.

• OPTIMA 7000 Fill Line

  Ajinomoto Bio-Pharma Services is a leader in aseptic filling, offering a wide range of capabilities for vials with our OPTIMA 7000 fill line. The OPTIMA VFVM 7000 safely processes various types and classes of biopharmaceutical products in 2 mL to 100 mL sizes.

• A Fill Finish Manufacturing Partner With Resources, Solutions, And Agility

  We offer a unique range of formulation and aseptic filling in vials, prefilled syringes, or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

• Fully Integrated CDMO Services To Improve The Health Of Humankind

  We provide therapeutic drug development and manufacturing services to biotechnology and pharmaceutical companies worldwide. We have the power to make your therapeutic vision a reality — from pre-clinical through commercial production.

• From Bench To Batch: Strategies For Scaling HPAPI Production

  Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.

• Oligonucleotide Therapeutics: Bridging From Research To Commercial

  Examine the development and manufacturing expertise required to seamlessly transition from research to commercial stages to ensure smooth operation from early to late stage development.

• Plasmid Production: Utilizing An Integrated Project Teams Approach

  Learn how an integrated project teams approach and efficient project management help to maintain timelines and avoid detrimental delays.

• Ajinomoto Bio-Pharma Services Capacity Update March 2023: Cell & Gene

  Ajinomoto Bio-Pharma Services is a leading provider in biologics manufacturing, using patented technologies and providing impeccable quality for 25 years.

• Leveraging Expertise For Plasmid Production Success

  Review how ensuring the consistency and yield of your plasmid production can help you de-risk the outsourcing process and ultimately reduce costs on your path to market.

• Delivering Top Quality Fill Finish Manufacturing

  Bringing an innovative parenteral drug product to market requires a fill finish manufacturing partner with the resources and solutions to deliver top quality products and the agility to meet your needs.

• Best Practices To Avoid Common Pitfalls In Plasmid Sourcing

  Explore the benefits of partnering with an experienced CDMO and learn the best practices to ensure seamless plasmid production.

• Considerations For Complex Formulations: How To Simplify Your Outsourcing

  Experts share the necessary development and manufacturing considerations for a smooth tech transfer, exploring these challenges in depth, and discuss the questions you should be asking your manufacturer.

• Pros Of Working With A GMP-Based Plasmid Manufacturer

  Leveraging the consistent supply and quality systems of a GMP-based plasmid manufacturer ensures high-quality production and a cost-effective process as you aim to bring your novel therapeutic to market.

• Plasmid Manufacturing For Gene Therapies: An Outsourcing Partnership

  With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise and equipment for plasmid DNA production is critical.

• Shifting Strategy: Advanced Approaches To Plasmid Production

  Explore the benefits of working with a CDMO that has extensive plasmid experience and integrated project teams across the production process.

• Sustainable Approaches To Oligonucleotide Manufacturing

  An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.

• Ajinomoto Bio-Pharma Services Capacity Update October 2023: Biologics

  Review Aji Bio-Pharma’s array of clinical through commercial manufacturing capabilities as well as the new high speed multi-purpose fill finish line in its state-of-the-art facility.