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Aurigene Pharmaceutical Servicesは、高活性薬理物質(HPAPI)の開発と製造(最大OEL 0.1µg /m³)で20年以上の経験を持っています。 開発初期段階から商用生産まで多数のプロジェクトを手掛けており、弊社サイエンティスト、毒性、規制および分析の専門家チームが、世界中のクライアントの要件を的確に満たすべく従事しています。


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Aurigene PharmaceuticalServicesが高活性薬理物質(HPAPI)の開発と製造のニーズをどのようにサポートできるのか

  • 徹底した安全の取り組みと封じ込め管理
  • 高薬理活性の原材料、中間体、および、充填、ろ過、乾燥、分注、パッケージングなどのAPI用cGMPアイソレーターシステム(最大OEL0.1µg /m³
  • グラムから数キログラムまでの量の複雑な物質の供給
  • サンプリング、ディスペンス、反応、分離、乾燥プロセスからなるアイソレーター
  • 高封じ込め閉鎖ツールキット
  • アイソレータ内の負気圧
  • アイソレータ内の負気圧

Aurigene Pharmaceutical Services is

one of the leading contract research organization (CRO)

provides the best contract research manufacturing


APSL is experienced in providing end-to-end solutions in HPAPI development and manufacturing (up to OEL 0.1 microg/m3), for almost over two decades. With multiple projects being handled from early development to commercialization, our team of scientist, toxicologist, regulatory and analytical experts are ideally positioned to meet the requirements of our global clients.

At APSL classification of HPAPI molecules is done based on the risk assessment process which is a scientific approach by which potential exposure risk is assessed adequately and the appropriate control strategies is applied. The classification standard is a stepwise process on how to perform a risk-based safety assessment while handling potent compounds, how to determine whether the exposure risk is managed appropriately, and which options are available when selecting exposure controls. Assessments are performed on a case-by-case basis where the greatest exposure risk is given the highest priority.

Performance Based-Exposure Controls Limits

The performance-based approach is predicated by the inextricable association of two components: A hazard classification scheme used to assign compounds into one of a series of health hazard categories of increasing severity based on their inherent pharmacological and toxicological properties, and applying risk based corresponding predefined strategies known to provide the necessary degree of control to employees and the environment for compounds in those categories.

Table 1: PB-ECL Categorization

Environment criteria PB-ECL Band
  1 2 3 4 5
OEL (if known) microg/m3 1000 or More 100 - 999 10 – 99 1 - 9 < 1.0
Acute Exposure
Acute Toxicity Low Moderate High Extreme Highly extreme
Severity of acute (life threatening) effects Negligible Low Moderate High Extreme
Chronic Exposure
Sensitization Not a sensitizer Slight cutaneous allergic reaction Moderate/strong cutaneous reaction (Skin effect) moderate to strong respiratory allergic reactions (Skin contact or inhalation) Extreme Sensitizer
Mutagenicity Negative Negative Positive in some Mutagenic in Mutagenic in
      in vitro assays, not confirmed in vivo most relevant in vivo and in vitro Assays (heritable genetic damage) most cases
Carcinogenicity Negative Negative Some evidence in animals (limited evidence) Confirmed animal and human (Inhalation) Carcinogenic
Reversibility Readily Reversible Readily Reversible Moderately Reversible Slowly reversible Irreversible

Table 2: Exposure potential evaluation

  Low Medium High
Low (< 1Kg ) EP1 EP1 EP1 EP2 EP2 EP3
Medium (1Kg-10Kgs) EP1 EP2 EP2 EP3 EP3 EP4
High (>10 Kgs) EP2 EP3 EP3 EP4 EP3 EP4
Task Duration Short Long

New product development shall involve handling of high potent API drug substances at different stages with different concentration levels and physical forms. Such drugs being highly potent and cytotoxic in nature, the open handling of active drug substance or drug product can be a threat to the human and environment. With various options available for containment at source and considering the flexibility required during operations it is a critical to decide containment strategy. This decision must be balanced between control by design (engineering control) and procedural control without compromising on personnel safety, product quality, and process requirements, to provide a system that will meet the current and anticipated future needs for the facility. Choice of handling method will greatly influence system performance and design. Hence a containment control strategy is developed based on the various parameters affecting selection of containment system and standard established guidelines for the same. All state-of-the-art technology shall be reviewed to contain product and avoid human exposure. Different technological applications shall be evaluated to ensure containment expectation are met. This would include the sophisticated technology such as containment at source using split valves, alpha beta port technology isolator, cRABs (Closed restricted access barriers), Biosafety / Cytosafety cabinet / Fume hood etc. Process for defining a control strategy and selection of appropriate containment systems is covered in the subsequent sections of this document.


In practice, containment is a term used for providing engineering controls to achieve all the three namely

  • Protection of personnel from a product
  • Protection of environment from a product.
  • Protection of a product from personnel and environment.

Product Transfer operations involving hazardous material present a hazard to the operator. A suitable containment system will be selected at each operating steps that will reduce the level of exposure to below a safe, acceptable limit. Degree to which operators may be exposed to and harmed by release of hazardous materials during product handling operations depends on four main factors, namely:-

Physical form of the material

  • Scale of operation
  • Hazardous properties of the material
  • Methods used to handle the material

Exposure could be a result of direct contact with:-

  • Process material during transfer
  • Residuals or releases from mechanical or closed transfer system during plant Cleaning and maintenance operations.

Critical factors for Risk Assessment Process of handling HPAPI handling are:

a) Material form (Dustiness Potential)

Dustiness Characteristics
Low Pellet like, non-friable solids
Medium Granular or crystalline, visible dust, settles quickly
High Fine light powders with dust cloud potential
  • When dustiness potential of material is not known; then it is assumed as high for all solid material handling and low for all wet cake, slurry and solutions handling.

b) Duration of Task

Short term –A task duration of < 30 minutes is considered to be short
Long term ->30 minutes or longer

c) Scale of operation

Operation Scale
Lab < 1 Kg(solids) Small
Transfers in range 1- 10 Kg(solids) Medium
Large Scales production transfers- > 10 kg (solids ) Large

Our HPAPI facilities are equipped with instruments like HPLCs, GC, FTIR, TOC, auto-titratator, Dissolution tester with auto sampler.

QC offers the following facilitates

  • Sampling and testing of incoming materials,
  • In process and finished product,
  • Sampling and testing of water
  • Stability analysis
  • Sample preparation inside the isolator in a dedicated room
  • Calibration of instruments
  • Environmental monitoring
  • Sterility testing
  • Microbial limit testing
  • Endotoxin testing

APSL can handle molecules of OEL up to 0.1 μg/m3Protecting environment, people & product.

HPAPI development and manufacturing (OEL: 1-5)

Phase Development/PoC Pre-clinical/NGMP Early Phase Late Phase Commercial
Quantity 10-50g 100-250g 1-3kg 5-10kg 10-15kg
Facility Hyderabad Hyderabad Hyderabad Vizag Hyderabad Vizag Hyderabad Vizag
Capacity Lab Lab ~20 Lts to 2000 L ~160 L – 2000 L ~160 Lt to 2000

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