化学、製造、管理 (CMC) サービス

創薬

• IND申請前CMCサポート 
• ソルト&ポリモーフィックセレクション 
• BCS/バイオエンハンスメント 
• 製剤選択 
• in silico/モデルを活かしたCMC支援 
• Phase1の 仕様と手法 
• 初期安定性  
• 初期の治験用製品 
• 生体分子分析アッセイの開発 

前臨床

• 原薬のIDキーとなる出発物質、原料サプライヤー 
• 技術移転 
• スケールアップ 
• 長期的な毒性/臨床試験用に供給を継続  
• 放射性標識物質 
• 分析試験法の適格性確認およびバリデーション

臨床

• 初の商業用イメージ薬品製品の設計 
• 重要な試験の準備 
• 商業サプライチェーン 
• プロセス適格性評価/バリデーション済みのバッチ キャンペーン戦略 
• 登録の安定性  
• NDA/BLA 申請書類準備 

市販後調査

• 代理店からの質問への対応（情報リクエスト、CRL） 
• ブリッジング/バイオウェーバー戦略 
• 承認後のCMC変更のサポート 
• 製品ライン拡張（PLE）のための処方サポート 

原薬

• 原薬合成、出発物質、原価 

• 物理化学的特性評価  

• バイオ医薬品における上流および下流の処理 

製剤と供給

• 複数の投与形態 - 経口、非経口、局所、経皮 

• 特殊製剤 - 生物学的製剤、長時間作用型注射剤、配合剤、小児用製剤、凍結乾燥製剤、無菌充填/仕上げ

分析と品質

• フェーズに応じた分析方法の開発 

• フェーズに応じたAPI/製剤のリリース仕様 

• プロセス開発と品質設計（QbD） 

戦略

• CMCプロジェクト管理 

• CDMOの評価と監督 

• バイオウェーバー、生物学的同等性、IVIVCのための戦略 

• デューデリジェンス 

• 製造/サプライチェーン 

• 同等性評価（バイオ医薬品） 

規制関連

• 新薬臨床試験開始申請 (IND) 前、EOP2、NDA申請準備サポート 

• 規制当局との交渉、やりとり、会議同席 

Deven Shah, PhD

Senior Director, Integrated Drug Development

Deven Shah is Certara’s Chemistry, Manufacturing & Controls (CMC) lead helping clients with their drug development CMC needs.  Deven also supports the Certara Global Health practice area spending a significant amount of time attending to the Bill & Melinda Gates Foundation work.

Before joining Certara, Deven held positions of increasing responsibility and most recently as the Head of Pharmaceutical Development at Noven Pharmaceuticals and CMC/Preclinical Development Leader at GSK.  Deven’s impressive background includes extensive experience leading cross-functional matrixed teams comprising of senior leads and hands on experience of CMC development across all phases in formulation development & drug delivery for diverse routes of administration & therapy areas.  He also has extensive experience with conducting due diligences, managing biotech alliances, & identifying potential CROs for robust product development.  Deven has contributed to regulatory filings spanning from pre-IND to NDA filing stage as well as represented organizations in the regulatory interactions with global agencies.

Deven received his B.Pharm from Jadavpur University in Calcutta, India and Ph.D. (Pharmaceutics & Drug Delivery) from the University of Southern California.  He was the recipient of the Procter & Gamble award for excellence in graduate research in Pharmaceutics and Drug Delivery for his Ph.D. work.

Hien-Anh (HA) Bruno, PhD

Associate Director

Dr. Hien-Anh Bruno is an Associate Director in the Certara’s Chemistry, Manufacturing & Controls (CMC) group

Hien-Anh (HA) focuses on technical operations for novel therapeutics discovery and development, with an emphasis on clinical bioanalytical assays and CMC manufacturing processes across all therapeutic modalities (complex biologics, cell and gene therapies as well as small molecules).

HA works closely with toxicology, regulatory strategy and clinical pharmacology teams to ensure all aspects of CMC plus bioanalytical assays are compliant and ready for clinical trials and global regulatory submissions.

She has a track-record of building multiple teams/facilities, leading projects spanning from discovery, pre-clinical assessment to cGMP drug manufacturing, and has helped 40+ clients in developing and validating clinical PK/PD/ADA assays. Prior to joining Certara, she led the CMC team at Aceragen, managed the core R&D services at Exicure, assembled the tissue culture division at SAMDI Tech (a Charles River company), and led technical operations at Enzyme by Design Inc.

She obtained her PhD in Biochemistry at the University of Grenoble, her first postdoc training in System biology and Bioinformatics at the Institute Curie, and her second postdoc training in Structural Biology at the University of Illinois at Chicago.