Expediting Viral-Vector Based Vaccine Development for Covid-19: Solving the Supply Chain and Regulatory Challenges
As the impact of the Covid-19 pandemic continues to be seen across the world, government bodies, academic collaborations and pharma companies race to produce effective vaccine candidates. With more than 115 companies actively engaged in this endeavour, we see approximately 20% of these vaccine candidates focused on viral vector delivery systems, some already entering phase I clinical trials. Speed to clinic is of paramount importance, however, as producing a commercial vaccine can take many years; how then can we accelerate vaccine development with speed and safety in mind?
First entry into the heavily regulated world of GMP manufacturing and drug product release can challenging. Fortunately, working with experienced partners can guide and accelerate your progression from vector design to phase I manufacturing. In this presentation we will examine how integrated approaches to cell banking & testing; viral vector testing, cell culture media manufacturing and single use manufacturing solutions can be adopted into your production strategy to simplify progression and ensure rapid release of your drug product. Further we will present the regulatory testing requirements for each critical component and manufacturing process step and offer guidance on potential rapid release strategies.
Key Message of Webinar
- Sartorius viral vector expression platform integrated solutions will accelerate your vaccine development with speed and safety
- Sartorius cell culture media manufacturing services will increase safety of supply and continuity for vaccine manufacture and scale-up
- Sartorius ready to use buffer solutions will save time; money and provide quality assurance into your manufacturing process
- Cell bank manufacturing and testing of your MCB / WCB in a closed system with highly experienced production and quality professional ensures rapid movement from development to manufacturing
- Viral Vector regulatory biosafety testing is complex and time consuming, Sartorius can provide quality assured ready to use solutions to meet global regulatory standards and rapid testing solution strategies
Key Learning Objectives
- Sartorius integrated cell line testing & banking, viral vector testing, media manufacturing & single use manufacturing solution specific to viral vector manufacture
- Cell banking options and regulatory release requirements
- The complexity of ensuring viral safety from contaminating agents in a viral vector drug product and the methodologies to address this
- Viral Vector biosafety testing regulatory requirements for the Master Virus; Working Virus Seed Stocks, Bulk Harvest, Bulk drug Substance and Drug Product
- How to use rapid testing methods to accelerate the manufacturing process
スピーカー紹介
ロレイン・ボーランド
プロセス技術担当マネージャー
Lorraine Borlandは、バイオプロセス、細胞および遺伝子治療のシニアマーケティングエキスパートであり、30年以上の業界経験を持ち、cGMP |GLP品質保証、CDMO生物製剤製造のオペレーションディレクターからプロジェクト管理、事業開発、マーケティングまで。Lorraineは、ウイルス遺伝子治療、細胞治療、ウイルスワクチン、全細胞細菌ワクチン、プラスミドのプログラムを提供してきました。
ロレインは、BioPhorumの技術戦略とATMPのワークストリームで主導的な役割を果たすアドボカシー活動に深く従事しており、BIA製造諮問委員会(MAC)のメンバーでもあります。
エリカ・シュルツェ博士
事業開発および戦略的コラボレーションマネージャー
Ericaは、バイオプロセス技術の修士号と分子バイオテクノロジーの博士号を持つ薬剤師です。 ブラジル、カナダ、ドイツで研究職を歴任し、ワクチン、組換えタンパク質、遺伝子治療の生産の最適化に注力してきました。事業開発マネージャーとして、ザルトリウスの強みと市場の需要に合った新しいモダリティ、C&G、および従来の治療薬の機会を特定しています。重要なパートナーシップを形成し、クライアントに力を与える上での彼女のリーダーシップは、プロセス開発を最適化し、生産能力を強化する上で非常に重要です。